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PubMed2004

A randomized, double-blind, placebo-controlled trial of ramosetron for preventing nausea and vomiting during termination of pregnancy.

Women undergoing general anesthesia for dilatation and curettage have a high risk for postoperative nausea and vomiting. We therefore evaluated the efficacy and safety of ramosetron, a new compound having serotonin receptor antagonist activity, for preventing nausea and vomiting in termination of pregnancy. Eighty women scheduled for dilatation and curettage received, in a randomized, double-blind manner, an intravenous placebo or ramosetron at three different doses (0.15 mg, 0.3 mg, 0.6 mg) at the end of surgery (n = 20 per group). Emetic episodes and safety were assessed. The percentage of patients who were emesis-free (no nausea, no retching, no vomiting) during 0-24 h after anesthesia was 55% with ramosetron 0.15 mg (P = 0.5), 85% with ramosetron 0.3 mg (P = 0.02), and 90% with ramosetron 0.6 mg (P = 0.007), compared with 50% in the placebo group. No clinically serious adverse events due to the study drugs were observed in any group. Our results suggest that ramosetron 0.3 mg is an effective antiemetic for prophylaxis against emetic symptoms after dilatation and curettage. Increasing the dose to 0.6 mg provides no further benefit.

Abortion, Induced↗
PubMed1999

An audit of single dose epidural diamorphine during elective caesarean section at a district general hospital.

Mothers receiving combined spinal-epidural (CSE) anaesthesia for elective caesarean section (n = 188) were audited. A single dose of epidural diamorphine (2-3 mg) was given during surgery. Unless contraindicated, diclofenac 100 mg was given per rectum at the end of surgery. Postoperative analgesia was provided as oral Co-dydramol and diclofenac. All mothers were premedicated with ranitidine 150 mg and metoclopramide 10 mg orally. Observations were recorded for 24 h postoperatively. Pain, nausea, sedation and itching were assessed on a scale of 0 (nil), 1 (mild), 2 (moderate) or 3 (severe). All mothers were reviewed during the second postoperative day. Epidural supplements during surgery and administration of naloxone, systemic opiates and anti-emetics after surgery were recorded. Postoperative analgesia was prolonged and excellent. Over 92% of pain scores were mild or less. Two mothers complained of severe pain, which was resolved with oral Co-dydramol. Postoperative morphine was not used. Itching was common but not troublesome; mild (54%), moderate (16%), severe (3%); 7% of mothers received naloxone. Nausea was uncommon: mild (19%), moderate (10%), severe (2%); 16% of mothers received anti-emetics. Itching was less than previous reports with subarachnoid diamorphine. Single dose epidural diamorphine can be used during elective caesarean section rendering systemic opiates unnecessary.

Journal Article↗
PubMed1999

A randomised dose-comparison trial of granisetron in preventing emesis in children with leukaemia receiving emetogenic chemotherapy.

This randomised study was performed to assess the anti-emetic efficacy and tolerability of two-dose regimens of granisetron in children with leukaemia. 49 children with leukaemia were treated with three consecutive courses of high-dose methotrexate or cytarabine regimen. During the first course, patients were evaluated regarding the emetogenicity of each regimen. They were randomised in a crossover manner to receive 20 or 40 micrograms/kg of granisetron before the second and third course of chemotherapy. Neither emesis nor severe appetite loss were observed in over 80% of patients within the first 24 h in all treatment groups. There was no significant difference in the anti-emetic efficacy between the two-dose regimens of granisetron. However, complete protection was achieved less frequently on days 2 and 3. Older children and girls appeared to be less well protected. No adverse events attributable to granisetron were observed. Granisetron dose regimens of 20 and 40 micrograms/kg are, comparably, well tolerated and effective in controlling chemotherapy-induced emesis in the first 24 h, though this protection fails thereafter, particularly in older patients and girls.

Adolescent↗
PubMed1997

Nutrient intake and weight development in children during chemotherapy for malignant disease.

The aim of the study was to assess the actual daily oral intake of energy, protein, fat and carbohydrate in relation to current recommendations in children with malignant disease during chemotherapy and to follow their weight development. Dietary information was collected for 21 consecutive days via 7-day recording in 14 children, aged 5-16 years. The number of days with loss of appetite, vomiting, and the number of days on anti-emetic drugs were also recorded. The average daily energy intake decreased from 91% of the recommendation of the Swedish Nutrition Recommendations (SNR), before chemotherapy to 69% after start of chemotherapy. During days spent at home, the energy intake increased to 77% of SNR. Twenty-two per cent of the total energy intake during the hospital days came from sucrose. On average, the children experienced loss of appetite on 50% of the days, vomiting on 12%, and received anti-emetic drugs on 38%. On admission, the average SD score for body weight for the whole group was -0.09. The mean weight reduction after 1 week was 0.19 SD (P = 0.05) compared to the admission weight. The weight reduction 6 weeks (n = 10) and 3 months (n = 13) after the start of chemotherapy was 0.10 SD and 0.37 SD (P = 0.04), respectively.

Adolescent↗
PubMed2002

Abdominal vagal afferent neurones: an important target for the treatment of gastrointestinal dysfunction.

Vagal afferents are extensively distributed in the digestive tract from the oesophagus to the colon. They are involved in the reflex control of normal gastrointestinal (GI) tract function (e.g. secretion and motility) as well as reflexes more characteristic of diseases such as functional dyspepsia and gastroesophageal reflux disease (e.g. vomiting, disordered lower esophageal sphincter relaxation and gastric accommodation). They are also implicated in signalling non-painful sensations (e.g. nausea and early satiety) associated with disease. A variety of receptors has been identified on vagal afferents, which can either enhance (e.g. 5-HT3, CCK1, VR1 and NK1 receptors) or reduce (e.g. ghrelin, leptin, k-opioid and GABAB receptors) activity, offering a range of potential therapeutic targets. Commonly used laboratory species (e.g. rat and mouse) lack an emetic reflex, and the implications of this for models of upper GI disorders have been explored in the light of expanding knowledge of the neuropharmacology of the emetic reflex implicating glutamate, prostanoids, cannabinoids and substance P. Additional pathophysiological roles for vagal afferents (e.g. in thermoregulation, arousal and fatigue) are being investigated, raising the intriguing possibility of the vagus as a target in non-GI disorders.

Animals↗
PubMed1997

Frog experiment onboard space station Mir.

Japanese tree frogs (Hyla japonica) showed unique postures and behavior during an 8-day flight to the Russian space station Mir. When floating in the air, the animals arched their back and extended their four limbs. This posture resembles that observed during jumping or parachuting of the animals on the ground. Frog sitting on a surface bent their neck backward sharply, did not fold their hind limbs completely, and pressed their abdomen against the substrate. They walked backwards in this posture. The typical posture resembles that adopted during the emetic behavior process on the ground, although the posture in space lasts much longer. The possible mechanism of induction of this unique posture in orbit is discussed. Frogs in this posture might be in an emetic state, possibly due to motion sickness. Response behavior to some stimuli was observed in orbit. Body color change in response to the background color appeared to be delayed or slowed down. Response behavior to other stimuli showed little change as long as the animal maintained contact with a substrate. Once it left the surface, the floating frog could not control its movements so as to provide coordinated motility for locomotion and orientation. Adaptation to microgravity was observed in the landing behavior after jumping. Readaptation of the frogs to the Earth environment took place within a few hours after return. Postflight histological and biochemical analysis of organs and tissues showed some changes after the 8-day spaceflight. Weakening and density loss in vertebrae was noted. The beta-adrenoreceptor activity of the gastrocnemius was natriuretic decreased. Skin collagen and liver protein synthesis were lowered. The distribution of the atrial factor-like peptides in the brain was changed.

Adaptation, Physiological↗
PubMed2006

Discomfort on injection: a comparison between two formulations of propofol.

BACKGROUND AND OBJECTIVE: A randomized double-blind controlled trial was performed to determine if there was a difference in discomfort on injection between two preparations of propofol. A long-chain triglyceride preparation (LCT-propofol (Fresenius)) was compared against a medium- and long-chain triglyceride preparation (MCT/LCT-propofol (BBraun)). METHODS: One hundred and twenty ASA I-II patients listed for elective procedures were consented and randomized to receive either induction agent. A standard rate of infusion was used for induction of anaesthesia and subjects were questioned about discomfort until contact was lost. Discomfort was recorded as none, mild, moderate or severe. Incidence of postoperative nausea and vomiting and anti-emetic requirements were recorded in the postanaesthetic care unit. RESULTS: There was seen to be a 54% reduction in moderate/severe discomfort with MCT/LCT-propofol compared with LCT-propofol (P < 0.006). There was a 70% reduction in severe discomfort with MCT/LCT-propofol compared with LCT-propofol (P < 0.04). The term discomfort was used during the study because there is a wide array of unpleasant sensations felt by patients during propofol induction which are not always reported as pain. There was no significant difference in the incidence of postoperative nausea and vomiting or anti-emetic use between the two groups. CONCLUSIONS: There is a significant decrease in the incidence of discomfort with MCT/LCT-propofol compared with LCT-propofol. This difference is more marked in subjects reporting severe discomfort.

Adolescent↗
PubMed1998

International, multicentre, placebo-controlled study to evaluate the effectiveness of ondansetron vs. metoclopramide in the prevention of post-operative nausea and vomiting.

Ondansetron 4 mg was compared with metoclopramide 10 mg for prevention of post-operative nausea and emesis in in-patients undergoing major gynaecological surgery in this double-blind, randomized, placebo-controlled, multicentre study. A total of 1044 patients received a single intravenous (i.v.) injection of study medication immediately before induction of anaesthesia. Nausea and emesis were assessed over the 24 h post-operative period. Significantly more patients who received ondansetron experienced no emetic episodes (44%) compared with those who received metoclopramide (37%, P = 0.049) or placebo (25%, P < 0.001). No nausea was experienced by significantly more patients who received ondansetron (32%) than with patients who received metoclopramide (24%, P = 0.009) or placebo (16%, P < 0.001). In addition, fewer emetic episodes, less severe nausea and a reduced need for rescue antiemetics were also observed with ondansetron (P < 0.05 vs. metoclopramide and placebo). Metoclopramide and placebo-treated patients were also 1.5 times (95% Cl 1.5-4.2) and 2.5 times (95% Cl 1.1-2.0) more likely, respectively, to experience nausea post-operatively. Overall, ondansetron was the most effective antiemetic in this patient population.

Adolescent↗
PubMed1983

Purification and some physicochemical properties of toxic-shock toxin.

A procedure for the purification of a protein marker for the staphylococci isolated from toxic-shock syndrome patients has been developed. The purification procedure involves the removal of the toxic protein from culture supernatant fluids of toxic-shock syndrome associated Staphylococcus aureus strains FRI-1169 and FRI-1183 by batch absorption with CG-50 resin, ion-exchange chromatography on CM-Sepharose CL-6B, and gel permeation chromatography on Sephacryl S-200. The purified toxin is a simple protein with a molecular weight of 24 000 +/- 500 as determined by sodium dodecyl sulfate-polyacrylamide gel electrophoresis. The isoelectric point of the major band is 7.0 as determined by isoelectric focusing in polyacrylamide gels. The TS-toxin's reactivity with its specific antibody is not affected by tryptic digestion at pH 8.0 but is slowly reduced by treatment with pepsin at pH 4.5. The TS-toxin consists of 188 amino acid residues. Serine was shown to be the NH2-terminal amino acid residue by end-group analysis. Initial studies indicated the protein was emetic; thus tentatively it was called staphylococcal enterotoxin F. In this paper it is called TS-toxin because the emetic action in monkeys has not been confirmed.

Amino Acids↗
PubMed1999

Tropisetron or droperidol in the prevention of postoperative nausea and vomiting. A comparative, randomised, double-blind study in women undergoing laparoscopic cholecystectomy.

BACKGROUND: Women undergoing laparoscopic cholecystectomy are susceptible to postoperative nausea and vomiting (PONV). This study was undertaken to evaluate the efficacy of tropisetron or droperidol for preventing PONV after laparoscopic cholecystectomy. METHODS: In a prospective, randomised, double-blind trial, 120 female patients received either tropisetron 5 mg or droperidol 1.25 mg intravenously at the beginning of surgery. A standard general anaesthetic technique and postoperative analgesia were used. Nausea, emetic episodes and the need for rescue medication were recorded for 24 h postoperatively. RESULTS: Nausea was experienced by 55% of the patients in the tropisetron group and by 62% in the droperidol group (ns). The incidence of emetic episodes was 20% and 52% (P=0.001) in the two groups, respectively. Rescue antiemetic medication was needed in 42% and 50% (ns) of the patients, respectively. Patients in the droperidol group were more drowsy in comparison with patients in the tropisetron group, mean sedation score being 6.7 vs 5.7, respectively (P=0.023). No difference in other side-effects was observed. CONCLUSION: Tropisetron, when compared with droperidol, had no better efficacy on the prevention of postoperative nausea but resulted in a significantly lower incidence of vomiting after laparoscopic cholecystectomy.

Adult↗
PubMed1983

Pentamethylmelamine (PMM): Phase I clinical and pharmacokinetic studies.

PMM is a water-soluble alternative to HMM. PMM has been administered as an intravenous infusion to 17 patients in a Phase I clinical trial. The dose-limiting toxicities were nausea and vomiting which were observed in all patients at 500 mg m-2 and above. The dose was not escalated above 1300 mg m-2 where nausea and vomiting were severe, prolonged (greater than 24 h) and poorly controlled by anti-emetics. Haematological, hepatic and renal toxicities were not observed. Neurological toxicity was not observed at low doses (less than 500 mg/m2) but could not be determined at higher doses due to intensive anti-emetic therapy. Pharmacokinetic studies (100-500 mg m-2) indicated that PMM plasma levels are dose-dependent and that the PMM disposition-phase half-life is prolonged in patients with abnormal liver function. It is concluded that the severe toxicity of PMM will limit the clinical utility of this compound and hence Phase II trials are not recommended.

Adult↗
PubMed1989

The role of metoclopramide in acute and delayed chemotherapy induced emesis: a randomised double blind trial.

High dose metoclopramide is an effective anti-emetic for use with cisplatin containing chemotherapy regimens but can cause extrapyramidal reactions. Lorazepam and dexamethasone are increasingly being used to alleviate chemotherapy induced emesis. This trial has assessed the contribution of high dose metoclopramide to anti-emetic control when given with dexamethasone and lorazepam. Eight-one patients receiving chemotherapy, mainly for gynaecological malignancy, entered a randomised double blind cross-over trial comparing dexamethasone and lorazepam with or without a 24 h metoclopramide infusion. This was followed by oral dexamethasone with or without oral metoclopramide for three further days depending on the initial randomisation. Sixty-one patients were fully evaluable. Fifty-five received cisplatin containing regimens and six non-cisplatin regimens. There was a significant reduction in the number of episodes of vomiting during the first 24 h in patients receiving the metoclopramide combination (P = 0.0001). On first exposure to chemotherapy 45% of patients receiving dexamethasone, lorazepam and high dose metoclopramide had no vomiting while 67% had two episodes or less ('major control'). This compared to 11% total control and 25% major control in those receiving dexamethasone, lorazepam and placebo. The control of nausea in the first 24 h was also improved (P = 0.0001). There was no difference in the degree of nausea or vomiting during the following three weeks between those receiving oral dexamethasone alone and those receiving dexamethasone and metoclopramide. Both groups showed a significant increase in nausea in the three weeks following the second course of treatment when compared to the first (P = 0.0007). Extrapyramidal reactions were recorded in 11.5% of patients receiving metoclopramide. More patients stated a preference for the metoclopramide combination although this was not statistically significant (chi 2(1) = 0.29, P = 0.59). In conclusion the combination of dexamethasone and lorazepam can give major control of emesis in 25% of patients receiving very emetogenic chemotherapy. The addition of metoclopramide increases this to 67% on first exposure to chemotherapy, but at the expense of extrapyramidal reactions in 11.5%.

Adult↗
PubMed1992

Anticipatory nausea and emesis, and psychological morbidity: assessment of prevalence among out-patients on mild to moderate chemotherapy regimens.

The prevalence of nausea and emesis among a series of out-patients (n = 95) receiving mainly mild-to moderately-emetic cytotoxics, was assessed, along with levels of psychological morbidity. Particular focus was given to the rates of psychologically-based (anticipatory) nausea and emesis. Results indicated that 23% of patients experienced anticipatory nausea and the majority reported that this occurred before at least half of the previous treatment cycles. Both emetic challenge of chemotherapy regimen and younger age were linked to this anticipatory effect. The data clearly indicated that nausea and emesis, both post-treatment and in anticipation of treatment, carried a psychological cost with anxiety being highest in those experiencing anticipatory nausea and/or emesis. The role of anxiety in the aetiology of psychologically-based nausea and emesis was not evaluated and it is considered that a prospective study is needed to clarify the exact contribution of psychological factors in the incidence of both post-treatment and anticipatory side-effects.

Adult↗
PubMed1994

Methylprednisolone enhances the efficacy of ondansetron in acute and delayed cisplatin-induced emesis over at least three cycles. Ondansetron Study Group.

This double-blind multicentre study has been carried out in order to confirm the improvement of ondansetron's antiemetic efficacy when combined with a corticosteroid and to determine whether this increased efficacy is maintained over three chemotherapy courses. One hundred and two patients receiving their first course of cisplatin (50-120 mg m-2)-containing chemotherapy were randomised to receive one of the two following treatments: 8 mg OND i.v. injection and 120 mg MPD i.v. injection before chemotherapy, followed 8-12 h later by an 8 mg OND tablet and a 16 mg MPD tablet (oral treatment administered twice daily for 3-5 days): or 8 mg OND plus placebo i.v. injection before chemotherapy, followed by 8-12 h later by an 8 mg OND tablet and placebo p.o. (oral treatment administered twice daily for 3-5 days). The number of emetic episodes (EEs = vomits + retches) and the grade of nausea were recorded. Of the 101 patients studied (efficacy analysis), complete or major control (0-2 EEs) was experienced in 90.4% of patients in the first 24 h in the OND/MPD group compared with 71.4% of patients in the OND group during the first course. This difference in favour of OND/MPD was noted over the three courses and is statistically significant. In the control of delayed emesis (worst day between days 2 and 6) there is a trend in favour of the OND/MDP group during the first course [56.2% vs 43.2% for complete response (no emetic episodes)] which was statistically significant on courses 2 and 3. The global antiemetic control over the course was always in favour of OND/MPD, which leads to a better efficacy maintained over the three courses. Both treatments were well tolerated. The results of this study confirm the increased antimetic efficacy of ondansetron and methylprednisolone in combination in cisplatin-induced acute and delayed emesis which led to a better maintained efficacy over three repeated chemotherapy courses.

Acute Disease↗
PubMed1996

Impact of tumour burden on chemotherapy-induced nausea and vomiting.

We investigated how residual tumour burden after cytoreductive surgery was related to the occurrence of acute and delayed nausea and vomiting in 101 ovarian cancer patients receiving their first chemotherapy course. The anti-emetic treatment included ondansetron combined with dexamethasone or placebo. After chemotherapy all patients received ondansetron only for 5 days. Two categories of tumour burden (TB) were formed according to the diameter of the greatest residual tumour (< 2 cm = minimal TB and > or = 2 cm = large TB). Self-reports of nausea and vomiting were obtained for 15 days. Other potential predictor variables were assessed and included in multivariate analyses. Patients with large compared with minimal TB had more delayed emesis, especially on days 2-7. They also had more acute nausea. The aggravating effect associated with large residual TB was more evident in patients > or = 55 years. During the second week after the chemotherapy the occurrence of nausea was higher in patients > or = 55 years than in those < 55 years. This was seen primarily in patients with large residual TB. Predictors for no delayed emesis at all were anti-emetic treatment with dexamethasone, minimal tumour burden, low neuroticism and no history of motion sickness. The increased risk of "persistent' delayed nausea and vomiting seen in older patients with large tumour burden may have important clinical implications and warrants further attention.

Adolescent↗
PubMed1993

Ipecacuanha-induced emesis: a human model for testing antiemetic drug activity.

In a double-blind, randomized, parallel-group study, five groups of 10 healthy men received single 5-minute infusions of 8 mg, 4 mg, 1 mg, 0.25 mg, or 0.1 mg ondansetron (as hydrochloride dihydrate) 30 minutes before oral administration of 30 ml syrup of ipecacuanha. Emetic episodes and nausea (100 mm visual analog scale) were assessed over an 8-hour period. There were no emetic episodes after 8 or 4 mg ondansetron. Seven, nine, and 10 subjects vomited after 1 mg, 0.25 mg and 0.1 mg ondansetron, respectively, with median times to onset of 62, 31, and 37 minutes. Median peak nausea scores were 0 mm for both 8 and 4 mg ondansetron and 30, 53, and 26 mm for 1, 0.25, and 0.1 mg ondansetron. Adverse events were mild. This model showed a close correlation with clinically effective doses of ondansetron. It may be successfully and safely used to assess the antiemetic potential of 5-HT3-receptor antagonists in healthy subjects.

Adolescent↗
PubMed1997

Electrophysiological characterisation of tachykinin receptors in the rat nucleus of the solitary tract and dorsal motor nucleus of the vagus in vitro.

1. Recent studies have shown antagonists at the NK1 subtype of receptor for tachykinins are antiemetics and suggested that this may result from blockade of tachykinin-mediated synaptic transmission at a central site in the emetic reflex. 2. We have used intracellular recording in vitro to study the pharmacology of tachykinins in the nucleus of the solitary tract (NST) and dorsal motor nucleus of the vagus (DMNV). 3. Neurones in the NST were depolarized by substance P (SP), the presumed endogenous ligand for the NK1 receptor and these effects were mimicked by the NK1 agonists, SP-O-methylester (SPOMe), GR73632 and septide; however, SP was nearly an order of magnitude less potent than the latter two agonists. 4. In the DMNV, SP and NK1 receptor agonists evoked similar depolarising responses but SP appeared to be more potent than in the NST and was closer in potency to the other agonists. 5. NK1-receptor antagonists blocked responses to septide and GR73632 in the NST but had little effect on responses to SP and SPOMe. In contrast, in the DMNV the NK1-receptor antagonists blocked responses to septide and GR73632 but also reduced responses to SP and SPOMe. 6. Neurokinin A (NKA) was almost equipotent with septide and GR73632 in depolarizing both NST and DMNV neurones but these effects were not mimicked by a specific NK2-receptor agonist. Responses to NKA were unaffected by an NK2-receptor antagonist; however, the depolarizing effects of NKA were blocked by NK1-receptor antagonists. 7. Neurones in both DMNV and NST were unaffected by the endogenous NK3-receptor ligand, neurokinin B and by a specific agonist for this site, senktide. 8. The results with NK1 receptor agonists and antagonists suggest that the septide-sensitive NK1 site is involved in the excitation of both NST and DMNV neurones. The 'classical' NK1 receptor may play more of a role in the DMNV and a third unknown site may be responsible for the depolarizing response to SP in the NST. The effects of NKA are best interpreted as an action at the septide-sensitive NK1 site. This raises the possibility that anti-emetic action of the NK1 antagonists may be due to blockade of NKA transmission at the septide-sensitive site.

Animals↗
PubMed1998

A randomized trial of once vs twice daily administration of intravenous granisetron with dexamethosone in patients receiving high-dose cyclophosphamide, thiotepa and carboplatin.

The purpose of this study was to determine the optimal schedule of i.v. granisetron and dexamethosone for control of nausea and emesis in patients receiving high-dose chemotherapy (HDC). Seventy patients with breast cancer received high-dose cyclophosphamide, thiotepa and carboplatin (CTCb) for 3 consecutive days. All 70 received dexamethasone 12 mg i.v. and granisetron 1 mg i.v. prior to infusion of CTCb and were randomized to receive placebo (n = 37) or an additional identical dose of granisetron (n = 33) 12 h later. Beginning on day 2 of chemotherapy administration, 55 patients evaluable later self-administered a cocktail of diphenhydramine (benadryl), lorazepam (ativan) and dexamethasone (BAD). Fourteen of 37 patients (38%) receiving granisetron once a day and 15/33 (44%) receiving it twice a day had a complete response during the first 24 h following the first doses of chemotherapy (P = 0.52). In the 55 evaluable patients receiving BAD, 18 of 29 (62%) in the once daily group and 14/26 (54%) in the twice daily group required additional medications (P = 0.54). The median time to first emetic episode was 20 h (range 6.6-79.5) for patients receiving once a day and 21.4 hours (range 5.8-105.3) for patients receiving twice a day granisetron (P = 0.48). Five patients in the once daily and seven patients in the twice daily group had complete control of nausea and emesis throughout the study period (P = 0.37). It was concluded that there were no statistically significant differences in nausea and emetic control between dexamethasone with once daily or twice daily i.v. granisetron administration in patients receiving high-dose CTCb.

Adult↗