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PubMedDate not supplied

Efficacy and tolerability of oral ondansetron versus prochlorperazine in the prevention of emesis associated with cyclophosphamide-based chemotherapy and maintenance of health-related quality of life.

This study compared the efficacy and tolerability of oral ondansetron (8 mg twice daily [BID] for up to 3 days) with those of phenothiazine prochlorperazine (10 mg BID for up to 3 days) in 133 cancer patients receiving cyclophosphamide-based chemotherapy. In addition, the study evaluated the impact of these treatments on patients' health-related quality of life, measured with both the Functional Living Index-Cancer and the Functional Living Index-Emesis questionnaires. The first dose of study drug was administered 30 minutes before initiation of chemotherapy. Patients received a rescue antiemetic at their request or if the investigator deemed it necessary. There was a statistically significant difference in the number of patients with no emetic episodes over the 3-day study period: 60% in the ondansetron group compared with 21% in the prochlorperazine group. Twenty-five percent of ondansetron-treated patients compared with 68% of prochlorperazine-treated patients experienced three or more emetic episodes, rescue medication use, or withdrawal from the study due to emesis or adverse events. Among patients with at least one emetic episode, the mean time to emesis was significantly longer (13 hours and 37 minutes) in the ondansetron group compared with the prochlorperazine group (9 hours and 30 minutes). Nausea and appetite scores did not differ significantly between groups. The score on the vomiting subscale of the Functional Living Index-Emesis was significantly more favorable in the ondansetron group compared with the prochlorperazine group, indicating better maintenance of health-related quality of life in ondansetron-treated patients. Both treatments were well tolerated. The most common potentially drug-related adverse event was headache, which occurred in significantly more (16%) ondansetron-treated patients compared with prochlorperazine-treated patients (3%). The results of this study demonstrate that oral ondansetron 8 mg BID for up to 3 days is more effective than prochlorperazine 10 mg BID for up to 3 days in the prevention of emesis associated with moderately emetogenic chemotherapy.

Adult↗
PubMed2001

Imiquimod-elicited emesis is mediated by the area postrema, but not by direct neuronal activation.

The immunomodulator, imiquimod, has been shown to have antiviral and antitumor properties in animal models. It also has been reported to alter cytokine levels in both animals and humans. However, because imiquimod appeared to be emetic, studies were conducted to determine the degree of sensitivity, and the pathways involved. Subcutaneous administration of > or = 10 mg/kg imiquimod to ferrets elicited emesis with latencies as short as 2'; 12 and 15 mg/kg were optimal doses. Emetic responsiveness was eliminated by complete ablation of the area postrema, but was unaffected by bilateral supradiaphragmatic section of the vagus nerve. This indicates that the emesis is produced by an activation of the chemoreceptor trigger zone B the area postrema. Ferret brain stem slices (450 microm) were preincubated in oxygenated Krebs-Ringer and then mounted in a submerged slice recording chamber. Extracellular recordings of spontaneous and ionophoretically evoked activity of area postrema neurons were obtained for up to 8 h, while the effect of bath-applied imiquimod was determined. Under control conditions, neurons showed a low frequency spontaneous discharge. Introduction of imiquimod (concentration range, 1 x 10(-7) to 5 x 10(-8)M) had no effect on neuronal firing. With ionophoresis of glutamate from an independent micropipette, a brief excitatory response was obtained. We conclude that imiquimod does not directly excite area postrema neurons. It is likely that imiquimod causes synthesis and release of some unknown emetic substance(s), very possibly cytokines.

Aminoquinolines↗
PubMed1993

Prevention of emesis by ICS 205-930 in children receiving cytotoxic chemotherapy.

Nausea and vomiting are among the most frequent and severe acute side-effects of cytotoxic therapy and are not optimally controlled by conventional antiemetics. This situation warrants the evaluation of new classes of antiemetic agents such as the 5-HT3 receptor antagonists. 19 children with a median age of 9 years (range 2-16 years), treated with cytotoxic drug combinations that had previously caused nausea and vomiting refractory to conventional antiemetics, were given the selective 5-HT3 receptor antagonist ICS 205-930. The drug was given intravenously (i.v.) at 0.2 mg/kg (maximum 5 mg) during the chemotherapy infusion period and was continued orally for up to 5 days in chemotherapy courses containing cisplatin. The number of emetic episodes was recorded and the response was scored according to following scale: grade 1 = no nausea, no emetic episode; grade 2 = up to four episodes of vomiting and less than 5 h of nausea; grade 3 = five or more than five emetic episodes and/or nausea for at least 5 h. The 19 patients received a total of 169 various courses of chemotherapy combined with ICS 205-930. A score of 3 was observed during one course only, a score of 2 in 37 out of the 169 courses, including the four courses with cisplatin. The drug was very well tolerated. Side-effects possibly related to ICS 205-930 were mild to moderate headache in 4 patients during seven courses overall and obstipation in 3 patients during 11 courses. The results strongly suggest that ICS 205-930 is a highly effective and safe antiemetic agent in non-naive pediatric patients receiving non-cisplatin cytotoxic chemotherapy and who had failed conventional antiemetic treatment.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed2002

Emesis: antiemetic effect of cyclophosphamide at central receptors of multitransmitter system in the cat.

The antiemetic and emetic actions of the anticancer drug cyclophosphamide injected intracerebroventricularly (i.c.v.) and intravenously (i.v.) through chronically implanted cannulae were investigated in unanaesthetized cats. Cyclophosphamide in single doses was injected into the cerebral ventricles and intravenously for 5 consecutive days. The antiemetic effect was regularly obtained, whereas the emetic effect was unpredictable and of low incidence. The antiemetic effect of i.c.v. and i.v. cyclophosphamide was assessed, when the neurotoxic (mydriasis, restlessness, emesis, ataxia, muscular weakness) signs subsided, against i.c.v. noradrenaline- and clonidine-induced emesis. Noradrenaline-induced emesis was dose-dependently and dose-independently inhibited with i.c.v. and i.v. cyclophosphamide. On the other hand, i.c.v. cyclophosphamide inhibited the clonidine-induced emesis in dose-independent manner, while i.v. injection of the anticancer drug had no significant effect on the emesis. The inhibition of emesis was consistently obtained and no significant differences in the antiemetic potency were found between 1 and 5 consecutive days of treatment with cyclophosphamide. However, the inhibition of noradrenaline-induced emesis was dose-dependent only after first administration of i.c.v. cyclophosphamide. It is assumed that noradrenaline acts at alpha-adrenoceptors within the area postrema and clonidine at alpha-adrenoceptors within and outside the area postrema as well as at muscarinic cholinoceptors, 5-hydroxytryptamine, dopamine and histamine H1 and H2 receptors, outside the area postrema, of multitransmitter system subserving the central regulation of emesis. It is suggested, therefore, that the antiemetic effect of cyclophosphamide at the receptors of the multitransmitter central emetic system is non-specific. In general, the antiemetic effect, even non-specific, of an anticancer drug could have practical implication. Namely, when a combination of two or more anticancer drugs are used for chemotherapy, the emesis could not occur if one of them could antagonize the emesis induced by other anticancer drug/s. Finally, cyclophosphamide injected i.c.v., but not i.v., evoked shortlasting emesis in about 20% of cats. Since the emesis was unpredictable and of low incidence it was not possible to study the mechanism/s and site/s of action of the anticancer drug.

Animals↗
PubMed1997

The efficacy of a combination of ondansetron, methylprednisolone and metopimazine in patients previously uncontrolled with a dual antiemetic treatment in cisplatin-based chemotherapy. The French Ondansetron Study Group.

BACKGROUND: Cisplatin is one of the most effective cytotoxic drugs used in the treatment of certain neoplasms, but is also one which most frequently induces nausea and vomiting. Combination of corticosteroids with ondansetron enables greater control of emesis than that obtained with ondansetron alone, but some patients still experience symptoms. The objective of this randomised, double-blind, multicentre, parallel group study was to examine the benefit of the addition of metopimazine (MPZ), a dopamine receptor antagonist, to the combination of ondansetron + methylprednisolone (O + M) in the prevention of cisplatin-induced nausea and vomiting in patients uncontrolled [i.e., at least one emetic episode (vomiting and/or retching) or moderate or severe nausea] during their previous course of cisplatin based chemotherapy, despite antiemetic treatment with a combination of a 5-hydroxytryptamine3 receptor antagonist (5HT3) with a corticosteroid. The impact of the treatment on the patients' quality of life was also evaluated using two specific questionnaires the FLIC (Functional Living Index for Cancer), and the FLIE (Functional Living Index for Emesis). PATIENTS AND METHODS: The intent-to-treat population consisted of 338 patients; 168 patients received the triple combination of ondansetron, methylprednisolone and metopimazine (O + M + MPZ), and 170 patients received ondansetron plus methylprednisolone (O + M). Tumour type was comparable in the two treatment groups, the most prevalent being lung cancer. Patients in group O + M + MPZ received ondansetron as an 8 mg intravenous injection prior to chemotherapy on day 1 followed by 8 mg tablets b.i.d. from D2 to D3, methylprednisolone as a 120 mg intravenous injection prior to chemotherapy on D1 and followed by 16 mg tablets b.i.d. from D2 to D3, and metopimazine as a 40 mg intravenous injection prior to chemotherapy on D1 and followed by 15 mg capsules b.i.d. on D2 to D3. Patients in group O + M received treatment with ondansetron and methylprednisolone as above. RESULTS: Analysis of the primary efficacy criterion (absence of emetic episode throughout the course of chemotherapy) revealed a success rate of 53% in the group receiving O + M + MPZ and 38% in the group receiving O + M (P = 0.008). Analysis of the secondary efficacy criteria (nausea grade, number of emetic episodes and global patient satisfaction on D1 and from D2 to D3) showed a statistically significant difference between the two groups, in favour of the O + M + MPZ treatment. The scores obtained with the FLIC and FLIE questionnaires did not reveal any significant differences between the two groups. Treatment was well tolerated in both groups. CONCLUSION: The study showed that the addition of MPZ to the combination O + M was an effective and well tolerated antiemetic treatment, with a 15% increase in efficacy compared to the combination in patients not controlled during their previous course of chemotherapy. The addition of metopimazine to existing regimens containing 5HT3 receptor antagonist and steroid combination should be considered for patients who fail on their previous course.

Adolescent↗
PubMed1992

Ondansetron is effective in decreasing postoperative nausea and vomiting.

The efficacy of ondansetron, a selective 5-HT3 receptor antagonist, in preventing postoperative nausea and vomiting in surgical patients was studied. Fifty women were randomized in a double-blind manner to receive either two 8 mg doses of intravenous ondansetron or two doses of placebo vehicle: the first given just before general anesthesia induction and the second 8 hours later. During the first 24 postoperative hours, the number of emetic episodes was recorded and the subjects rated their nausea on a scale from 0 to 10. Ondansetron-treated subjects had fewer emetic episodes (p less than 0.001) and lower subjective nausea scores (p less than 0.001). The number of complete responders (no emetic episodes and no rescue therapy) was 1 of 24 (4%) and 15 of 26 (58%) in the placebo and ondansetron groups, respectively (p less than 0.001). Ondansetron is clearly more effective than placebo in the prophylaxis of postoperative nausea and vomiting. The adverse event profile for ondansetron was similar to that of placebo.

Abdomen↗
PubMed1999

Antiemetic efficacy of granisetron plus dexamethasone in bone marrow transplant patients receiving chemotherapy and total body irradiation.

Few trials exist regarding the antiemetic efficacy of granisetron in bone marrow transplant (BMT) recipients conditioned with high-dose chemotherapy and total body irradiation (TBI). In this single-center, open-label, prospective, trial, the antiemetic efficacy and safety of granisetron plus dexamethasone were evaluated in 26 patients conditioned with cyclophosphamide-containing regimens (the majority receiving 60 mg/kg per day on 2 consecutive days), and TBI (12 Gy divided over 4 days). Daily intravenous doses of granisetron 1 mg plus dexamethasone 10 mg were given 30 min prior to chemotherapy or radiation, and continued for 24 h after the last conditioning treatment for a median of 6 days (range 3-9). Emetic control was defined by the number of emetic episodes occurring within a 24 h period, or the requirement for rescue medication for nausea or vomiting. A total of 25 patients completed 186 evaluable treatment days. Response (emetic control by treatment days) was complete in 50% of patients, major in 48%, minor in 2%, and there were no failures. Adverse effects were minor, with diarrhea (15%), headache (14%), and constipation (11%) reported most often. Based on these results, the antiemetic regimen of granisetron plus dexamethasone appears effective and well tolerated during BMT conditioning with high-dose cyclophosphamide and TBI.

Activities of Daily Living↗
PubMed2000

Granisetron (Kytril) plus dexamethasone for antiemetic control in bone marrow transplant patients receiving highly emetogenic chemotherapy with or without total body irradiation.

This prospective trial evaluated the efficacy and toxicity of granisetron for antiemetic control in patients receiving high-dose cyclophosphamide (CY)-containing regimens with/without TBI for bone marrow (BM) or peripheral blood stem cell (PBSC) transplantation or PBSC mobilization. Granisetron 1 mg i.v. plus dexamethasone 10 mg i. v. were administered daily 30 min before chemotherapy or radiation for a median of 5 days. Response was defined as the number of emetic episodes per 24 h: complete response, 0 and no emetic rescue; major response, 1-2; minor response, 3-5; failure, >5. One hundred patients were enrolled. Ninety-eight received CY-containing regimens and 26 of these additionally received TBI (12 Gy divided over 4 days). Response was complete on 216 (47%) of a total 456 patient days, major on 222 (49%), minor on 14 (3%), and failure on 4 (1%). Mean number of emetic episodes per patient per day and breakthrough medication required per patient per day was 0.24 (range 0-8) and 0. 40 (range 0-8), respectively. Adverse effects were minimal, with headache (20%) reported most frequently. Based on these results, granisetron plus dexamethasone is an effective and well-tolerated antiemetic regimen in BMT/PBSCT recipients conditioned with high-dose chemotherapy with/without TBI. Bone Marrow Transplantation (2000) 25, 1279-1283.

Adult↗
PubMed2002

The effect of dexamethasone upon patient-controlled analgesia-related nausea and vomiting.

Ninety female patients were enrolled in this randomised, double-blind, placebo-controlled study to compare the anti-emetic effect of intravenous dexamethasone 8 mg with saline control in preventing patient-controlled analgesia-related nausea and vomiting following major orthopaedic surgery. The prophylactic administration of dexamethasone 8 mg significantly reduced the overall incidence of patient-controlled analgesia-related nausea and vomiting (p<0.001) and the need for rescue anti-emetics (p<0.01). Furthermore, patients who received dexamethasone showed a higher incidence of complete responses (no vomiting or need for rescue anti-emetic for a 24-h postoperative period) than those who received saline (p<0.05). We conclude that dexamethasone 8 mg may be valuable for preventing patient-controlled analgesia-related nausea and vomiting in women undergoing major orthopaedic surgery.

Adult↗
PubMed2003

A comparison of cyclizine, ondansetron and placebo as prophylaxis against postoperative nausea and vomiting in children.

Nausea and vomiting is a relevant and common problem with unfavourable sequelae in children undergoing some plastic surgery procedures. There is a lack of anti-emetic trials performed in children, with only a few investigating the roles of the older anti-emetic agents such as cyclizine compared with newer ones such as ondansetron. This randomised, controlled, double-blind study examined the effectiveness of a single dose of ondansetron (0.1 mg x kg-1), cyclizine (20 mg) and placebo (normal saline) in the prevention of postoperative nausea and vomiting in 150 children (mean age 3.6 years) undergoing plastic genitourinary procedures. Rates of previous postoperative nausea and vomiting and motion sickness were comparable across the groups. Postoperative vomiting was significantly reduced with ondansetron prophylaxis (p = 0.006) but there was no detectable anti-emetic effect with cyclizine. Furthermore, cyclizine caused pain on injection (p < 0.001).

Analgesics, Opioid↗
PubMed1999

Dimenhydrinate for prevention of post-operative nausea and vomiting in female in-patients.

Dimenhydrinate is an inexpensive antihistaminic drug, that is frequently used as an anti-emetic during anaesthesia. The popularity of the drug is contrasted by the lack of modern studies concerning its efficacy in reducing the incidence of post-operative nausea and vomiting. Thus, dimenhydrinate was compared with placebo in this prospective, randomized, double-blind study. One hundred and thirty-three female in-patients were studied. They were stratified according to the type of surgery (laparoscopic cholecystectomy, thyroid resection or knee arthroscopy) to ensure an homogeneous distribution in both groups. General anaesthesia was induced with etomidate, fentanyl, vecuronium and maintained with enflurane in N2O/O2. Neuromuscular block was reversed with pyridostigmine/atropine. Patients in the dimenhydrinate group (n = 67) received 62 mg dimenhydrinate intravenously after induction of anaesthesia. Placebo patients (n = 66) received saline. Administration of dimenhydrinate (and placebo) was repeated three times during the 48-h study to mitigate the short half-life of the drug. Post-operative analgesia and anti-emetic rescue medication was standardized. Episodes of vomiting, retching and the need for additional anti-emetics were recorded. Nausea was assessed using a 10-cm visual analogue scale. Post-operative nausea and vomiting was rated as 'none', 'mild', 'moderate' and 'severe' using a fixed scoring algorithm. There were no differences between the two groups with regard to biometric data, type of surgery and distribution of risk factors for developing post-operative nausea and vomiting. In the dimenhydrinate group, more patients remained completely free from post-operative nausea and vomiting compared with placebo (dimenhydrinate: 38.8%; placebo: 15.1%; P = 0.004). The incidence of severe post-operative nausea and vomiting was also reduced from 39.4% to 14.9%. No relevant side effects were observed. Intra-operative dimenhydrinate, followed by three further administrations after surgery, reduces the incidence and the severity of post-operative nausea and vomiting without side effects. However, there still remained an unacceptable high number of patients who were not prevented completely from experiencing post-operative nausea and vomiting.

Adult↗
PubMed1999

An assessment of prochlorperazine buccal for the prevention of nausea and vomiting during intravenous patient-controlled analgesia with morphine following abdominal hysterectomy.

The effectiveness of prochlorperazine buccal as an anti-emetic for the prevention of post-operative nausea and vomiting in patients using intravenous patient-controlled analgesia with morphine following abdominal hysterectomy has been assessed in a randomized, double-blind, placebo-controlled study. Forty-nine female patients participated with 26 allocated to the prochlorperazine buccal group and the remainder to the placebo group. Each received either placebo or prochlorperazine buccal 6 mg, in each case by the buccal route, 1 h prior to anaesthesia with further doses at 6, 18, 30 and 42 h, respectively. Symptom scores in respect of nausea, pain and sedation, the number without nausea, the number without vomiting and the requirement for rescue anti-emetic therapy were noted for each 4-h period during the 48-h study. Morphine utilization and taste associated with the study material were recorded. Data for 21 patients in the placebo group and 25 patients in the prochlorperazine buccal group were available for analysis. Patients in the prochlorperazine buccal group showed significantly lower mean nausea scores at 4-8 h (placebo group: mean nausea score 0.95; prochlorperazine buccal group: mean nausea score 0.36; P < 0.05) and at 16-20 h (placebo group: mean nausea score 1.24; prochlorperazine buccal group: mean nausea score 0.48; P < 0.05). Furthermore, the prochlorperazine buccal group showed significantly more patients without nausea at 4-8 h (placebo group: 11 patients out of 21; prochlorperazine buccal group: 20 patients out of 25; P < 0.05) and at 16-20 h (placebo group: nine patients out of 21; prochlorperazine buccal group: 18 patients out of 25; P < 0.05). The prochlorperazine buccal group showed a significantly higher number of patients rating the taste as unsatisfactory (placebo group: two patients out of 21; prochlorperazine buccal group: nine patients out of 25; P < 0.05). Intravenous droperidol is the current gold standard prophylactic anti-emetic in post-operative nausea and vomiting associated with intravenous patient controlled analgesia with morphine usage. This study has demonstrated a peri-operative prochlorperazine buccal regimen to be effective in post-operative nausea and vomiting prophylaxis in the use of intravenous patient controlled analgesia with morphine. Prochlorperazine buccal should be considered as an effective, inexpensive option for the prevention of post-operative nausea and vomiting in post-operative intravenous patient controlled analgesia with morphine administration.

Administration, Buccal↗
PubMed1999

Droperidol and dimenhydrinate alone or in combination for the prevention of post-operative nausea and vomiting after nasal surgery in male patients.

Droperidol and dimenhydrinate are inexpensive antiemetic drugs. Droperidol, especially, has been studied extensively, but there are no studies on the combination of both drugs for prevention of post-operative nausea and vomiting. One hundred and forty male hospitalized patients undergoing nasal surgery were randomized to receive one of four anti-emetic regimes: placebo, dimenhydrinate (1 mg kg-1), droperidol (15 micrograms kg-1), or the combination of both drugs (droperidol 15 micrograms kg-1 + dimenhydrinate 1 mg kg-1) administered after induction of anaesthesia. Patients in the dimenhydrinate-group and the combination-group received a second dose of dimenhydrinate 6 h after the first administration to mitigate the short half-life of the drug. For general anaesthesia a standardized technique, including benzodiazepine premedication, propofol, desflurane in N2O/O2, vecuronium, and a continuous infusion of remifentanil, was used. Post-operative analgesia and anti-emetic rescue medication were standardized. Episodes of vomiting, retching, nausea, and the need for additional anti-emetics were recorded for 24 h. The main endpoint of this study was the number of patients who were completely free of post-operative nausea and vomiting (Fisher's Exact Test). Furthermore, the severity of post-operative nausea and vomiting was analysed using a standardized scoring algorithm. The incidence of patients completely free of post-operative nausea and vomiting was 62.9% in the placebo-group, 77.1% in the dimenhydrinate-group (P = 0.21), and 82.9% in the droperidol-group (P = 0.07). This increased to 94.3% in the combination-group (P = 0.0015). In all three treatment groups the severity of post-operative nausea and vomiting was reduced significantly compared with placebo treatment (P = 0.0003). The incidence of side effects was similar in the four groups. Dimenhydrinate was ineffective in reducing the incidence of post-operative nausea and vomiting and droperidol only reduced the severity of post-operative nausea and vomiting. However, the combination of both drugs significantly reduces the incidence of post-operative nausea and vomiting when compared with placebo treatment.

Adult↗
PubMed2002

Gender differences in narcotic-induced emesis in the ED.

Narcotic analgesia is commonly given in the emergency department. Narcotic-induced nausea and vomiting is thought to be a common occurrence, but the gender incidence and associations are not well defined. The aim of this study was to document the sex-related complication of nausea and vomiting after opiate administration for pain relief in the ED. The study hypothesis was that men and women have the same rate of narcotic-induced emesis in the ED. A prospective, convenience study of the use of narcotic analgesic on patients in an innercity Level I Trauma Center was undertaken. Information concerning the reason for narcotics, complications, number of doses, and route of administration were studied. The emergency physicians were allowed clinical judgment to treat the patients with any narcotic agent in any dose increment. The data were entered into an SPSS program (Chicago, IL). Analysis between groups (men v women) was then conducted by an independent t test. We compared the 2 groups across 6 categories: cause of injury, presenting pain scale, first drug given, first dose given, first route of drug, and requires an anti-emetic. A Bonferroni procedure was used to correct for the higher probability of significant findings when multiple tests were performed. All findings that are significant are after Bonferroni. The study was Institutional Review Board (IRB) approved. A total of 325 consenting patients were studied from October 1996 to April 1998. The patients consisted of 174 men and 151 women, with an average of 35.8 years of age. The race of the patients was 70% African American and 20% Hispanic. Of the total of 325 patients, 20.3% (74) required an anti-emetic because of nausea and/or vomiting. A significant difference occurred in causes of pain for women (t = 2.79, P <.007). The causes of pain for women were general pain, fracture, abdominal, back pain, and other as compared with men with gun shot wounds, general, fracture, low back, and flank. Women showed no significant difference with regard to presenting pain scale (t =.122, P <.903), first drug given (t = 1.643, P <.101), and first dose given (t =.708, P <.408). The majority of patients received morphine (55.4%), followed by meperidine (24.3%), and hydrocodone (13.5%). The most frequent route of administration was intravenous (IV, 45.2%), intramuscular (IM, 35.7%), with oral being the least frequent route (19.1%). There was a difference for women with first route given (t = 2.543, P <.01) and requires anti-emetic (t = 3.06, P <.002). The majority of women received IM (58.6%) versus IV (37.7%), whereas the majority of men (62.3%) received IV versus IM (41.4%). A significant number of patients became nauseated and/or vomited from Emergency Department-administered narcotics. The nausea and vomiting was associated with female sex and the cause of pain. A comparative study of other pain medications versus narcotics for incidence of induced nausea and emesis would be useful.

Adolescent↗
PubMed2001

[Prophylaxis of nausea and vomiting after thyroid surgery: comparison of oral and intravenous dolasetron with intravenous droperidol and placebo].

OBJECTIVE: Postoperative nausea and vomiting (PONV) are among the most common complications in operative medicine. Especially thyroid surgery is frequently associated with PONV. It was the aim of this study to determine the efficacy of oral and intravenous dolasetron in comparison to intravenous droperidol (DHB) and placebo in the prevention of PONV. METHODS: 93 female and 43 male patients undergoing thyroid surgery were stratified according to gender and then randomised to receive double-blind one of four antiemetic regimes: 50 mg dolasetron given orally 45 minutes prior to induction of anaesthesia (group I), 12.5 mg dolasetron given intravenously during induction of anaesthesia (group II), 1.25 mg DHB given intravenously during induction of anaesthesia (group III) or placebo (group IV). General anaesthesia and preoperative management of the patients were standardised: premedication with chloracepate-dipotassium, induction with thiopentone, sufentanil and rocuronium, maintenance with N2O/O2, sevoflurane and repetitive doses of sufentanil and rocuronium, postoperative analgesia with metamizol and piritramide, antiemetic rescue-treatment with dimenhydrinate, metoclopramide and triflupromazine. Number of emetic episodes, the need for additional antiemetics and adverse events were recorded for 24 hours. Efficacy was measured by "complete-response" (CR = 0 emetic episodes or 1 emetic episode after 4 hours and no rescue-treatment) and "total-response" (TR = complete response plus no nausea, i.e., < 5 mm VAS rating of patients maximum nausea). RESULTS: Men: Only Dolasetron given intravenously reduced nausea and vomiting significantly, Dolasetron given orally reduced nausea, but not vomiting, DHB had no significant effects: CR 72.7% (group I), 100% (group II), 80% (group III), 63.6% (group IV); TR 72.7% (group I), 81.8% (group II), 50% (group III), 36.4% (group IV). Women: In all three treatment groups significantly less patients suffered from PONV compared to the placebo group (p < 0.05). There were no differences between the treatment groups: CR 58.3% (group I), 45.8% (group II), 52.2% (group III), 18.1% (group IV); TR 37.5% (group I), 33.3% (group II), 39.1% (group III), 13.6% (group IV). There were no adverse events in any group. CONCLUSIONS: Our results confirm the expected high incidence of PONV after thyroid surgery, especially in female patients. Single doses of oral and intravenous dolasetron and intravenous droperidol reduced PONV effectively in female patients undergoing thyroid surgery. Dolasetron seems to be the more effective substance in male patients. Both substances can be administered safely and are well tolerated.

Administration, Oral↗
PubMedDate not supplied

Deoxynivalenol: toxicology and potential effects on humans.

Deoxynivalenol (DON) is a mycotoxin that commonly contaminates cereal-based foods worldwide. At the molecular level, DON disrupts normal cell function by inhibiting protein synthesis via binding to the ribosome and by activating critical cellular kinases involved in signal transduction related to proliferation, differentiation, and apoptosis. Relative to toxicity, there are marked species differences, with the pig being most sensitive to DON, followed by rodent > dog > cat > poultry > ruminants. The physiologic parameter that is most sensitive to low-level DON exposure is the emetic response, with as little as 0.05 to 0.1 mg/kg body weight (bw) inducing vomiting in swine and dogs. Chinese epidemiological studies suggest that DON may also produce emetic effects in humans. With respect to chronic effects, growth (anorexia and decreased nutritional efficiency), immune function, (enhancement and suppression), and reproduction (reduced litter size) are also adversely affected by DON in animals, whereas incidence of neoplasia is not affected. When hazard evaluations were conducted using existing chronic toxicity data and standard safety factors employed for anthropogenic additives/contaminants in foods, tolerable daily intakes (TDIs) ranging from 1 to 5 microg/kg bw have been generated. Given that critical data gaps still exist regarding the potential health effects of DON, additional research is needed to improve capacity for assessing adverse health effects of this mycotoxin. Critical areas for future DON research include molecular mechanisms underlying toxicity, sensitivity of human cells/tissues relative to other species, emetic effects in primates, epidemiological association with gastroenteritis and chronic disease in humans, and surveillance in cereal crops worldwide.

Animals↗
PubMed2003

A randomized double-blind trial to compare the clinical efficacy of granisetron with metoclopramide, both combined with dexamethasone in the prophylaxis of chemotherapy-induced delayed emesis.

BACKGROUND: The prophylactic use of 5-HT(3) receptor antagonists (setrons), after the first 24 h (acute phase) of exposure to emetic chemotherapy, to decrease the incidence of 'delayed phase' emesis increases costs. We designed a study to evaluate the efficacy of a setron (granisetron) in the delayed phase, compared with metoclopramide, each combined with a corticosteroid. PATIENTS AND METHODS: Patients on their first course of single-day emetic chemotherapy (cisplatin, carboplatin, doxorubicin, cyclophosphamide and others) received granisetron 2 mg p.o. and dexamethasone 8 mg p.o. on day 1, followed for 5 days by dexamethasone 4 mg p.o. od combined with either metoclopramide 20 mg p.o. tds or granisetron 1 mg bd in a double-blinded double-dummy protocol. Patients evaluated the results using a diary card. Randomization was stratified by institution, sex, emetic chemotherapy naïve versus previous, alcohol consumption and platinum versus non-platinum regimen. RESULTS: 131 evaluable patients received granisetron in the delayed phase, and 127 received metoclopramide. Control of acute emesis in both arms was similar (86% granisetron; 85% metoclopramide). The 35 patients experiencing acute emesis had poor control in the delayed phase, with only four granisetron and three metoclopramide patients having no or mild nausea and no vomiting. CONCLUSIONS: In daily practice, a combination of oral dexamethasone and oral granisetron achieves an extremely high control of acute emesis (86% protection). Our data suggest that routine prescription of setrons for delayed phase control is not advisable as it increases costs without any benefit for the majority of patients. Delayed emesis in the rare patients with acute phase emesis remains an unsolved problem.

Administration, Oral↗
PubMed1996

Effect of transdermal hyoscine on nausea and vomiting during and after middle ear surgery under local anaesthesia.

The efficacy of transdermal hyoscine in the reduction of nausea, retching and vomiting was compared with placebo during and after stapedo- and tympanoplasty under local anaesthesia in a double-blind, prospective and randomized study. In the placebo group (n = 29), 69% of the patients were free from emetic symptoms during and 41% after the operation. The corresponding figures were 93% (P < 0.05) and 74% (P < 0.05) in the hyoscine group (n = 27). The patients in the placebo group needed more droperidol during and after operation (P < 0.05). The frequency of side effects was similar in both groups. In posturography the patients with emetic sequelae in the placebo group had a markedly deteriorated upkeep of posture (P < 0.05) measured as body sway velocities. A strong correlation was found between motion sickness and emetic sequelae after surgery, and patients with a history of motion sickness benefited most from hyoscine.

Administration, Cutaneous↗