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PubMed1991

A comparison of controlled release metoclopramide and domperidone in the treatment of nausea and vomiting.

Dopamine antagonists are effective anti-emetics. Domperidone does not readily cross the blood-brain barrier and is less likely to cause central nervous system side-effects than metoclopramide. However, a direct comparison of the safety and efficacy of the two drugs has not hitherto been made. Ninety-five patients, with symptoms of nausea and vomiting due to a variety of oesophageal or gastric disorders, were recruited into a randomised, double-blind, three-part, parallel-group comparative study of controlled release metoclopramide 15 mg (Gastrobid Continus tablets, Napp Laboratories) given twice daily, and domperidone 10 mg or 20 mg given three times daily. Assessments for nausea, vomiting, reflux symptoms and adverse events were made on entry to the study. Patients were randomly allocated to one of the three treatment regimes for a period of seven days, throughout which daily symptomatology and use of escape medication were recorded on a diary card. At the end of the treatment period, nausea, vomiting and reflux symptoms, adverse events and a global assessment of patients' symptom control were recorded by the investigator. Both controlled release metoclopramide and high and low dose domperidone significantly reduced symptoms of belching, flatulence, distension, heartburn, regurgitation, reflux, nausea and vomiting compared to baseline. There were no significant differences between the three treatments in efficacy or in the number and severity of side-effects.

Delayed-Action Preparations↗
PubMed1990

Effects of steroids on postoperative nausea and vomiting.

The purpose of this study was to determine if the use of intraoperative steroids was effective in decreasing the incidence of postanesthetic nausea and vomiting and whether or not those complications were gender related. This retrospective study involved a chart review of 208 patients undergoing lumbar laminectomy at a large metropolitan hospital during a 10-month period in 1989-1990. Sixty-one patients met inclusion criteria and were accepted into the study. Of these, 34 patients had received an intraoperative steroid; 21 were male and 13 female. Twenty-seven patients did not receive intraoperative steroids; 17 were male and 13 female. Data collected included the number of pain medications and antiemetics used in the postoperative period, as well as the number of episodes of nausea and vomiting in the 24 hours following surgery. Results demonstrated that those patients who received intraoperative steroids were less likely to experience problems of nausea and vomiting than those who did not receive the drug. Requirements for postoperative pain medication were also reduced in the steroid group. Female patients in both groups were shown to have a greater incidence of nausea and vomiting than male patients.

Anesthesia↗
PubMed1989

Chemoradiotherapy toxicity during bone marrow transplantation: time course and variation in pain and nausea.

Chemoradiotherapy-induced toxicity following unmodified allogeneic marrow grafting was studied. Patients with hematologic malignancy (n = 157) received cyclophosphamide (120 mg/kg) followed by single or fractionated total body irradiation (TBI); aplastic anemia patients (n = 41) received only cyclophosphamide (200 mg/kg). Physicians rated mucositis, pain and nausea daily as (0) none, (1) mild, (2) moderate, (3) severe, (4) life threatening. Oral mucositis pain began several days prior to transplant, peaked during the second week after transplant, and declined thereafter. Patients with hematologic malignancies (maximum mean rating of 1.6, day 11) experienced more pain than aplastic anemia patients (maximum mean rating of 0.7, day 6). Nausea peaked before transplant and gradually declined. Nausea was higher (p less than 0.001) in patients with aplastic anemia (maximum mean rating of 1.3, day -2) than with hematologic malignancies (maximum mean rating of 0.9, day -6). There was no significant difference between single dose 1000 cGy and 6-day 1200 cGy irradiation. Recipients of 1575 cGy rather than 1200 cGy TBI had significantly (p less than 0.01) higher levels of pain (mean rating 1.25 and 0.82, respectively) and nausea (mean rating 1.27 and 0.72, respectively). Additional research is needed to determine the predictors, consequences and best methods of controlling these toxicities.

Adolescent↗
PubMed1989

Recent advances in the management of nausea and vomiting caused by antineoplastic agents.

The pathophysiology of nausea and vomiting caused by antineoplastic therapy is described, and the literature on selected recent pharmacologic approaches to antiemetic therapy is reviewed. Nausea and vomiting associated with antineoplastic therapy remain serious deterrents to continued, potentially curative therapy for many patients. Although much research has been conducted in the area of antiemetic therapy over the past decade, the mechanisms by which antineoplastic agents cause nausea and vomiting are still not well defined. The most effective antiemetic agents to date are those that antagonize dopamine receptors. Metoclopramide is a dopamine antagonist that has been widely studied for the prevention of antineoplastic-agent-induced nausea and vomiting. Recent studies with this agent focus on routes of administration other than the traditional high-dose intermittent bolus intravenous injections. Continuous intravenous infusions of the drug and high-dose oral administration have been studied in an attempt to decrease the adverse effects associated with the traditional regimen and to allow administration on an outpatient basis. Prochlorperazine, a phenothiazine derivative, has been a mainstay of antiemetic therapy for many years. Although it is generally reserved for use with regimens that cause mild to moderate emesis, recent data suggest that higher-than-traditional doses given intravenously impart greater antiemetic protection. Perhaps the most promising antiemetic research has been conducted with a new group of agents, the serotonin antagonists. Preliminary trials suggest that these agents are comparable in efficacy to high doses of metoclopramide but devoid of many of the adverse effects commonly associated with metoclopramide. Further research in the area of neuropharmacology is necessary to direct the development of the most effective antiemetic agents.

Animals↗
PubMed1987

Hormonal responses of metoclopramide-treated subjects experiencing nausea or emesis during parabolic flight.

Metoclopramide was orally administered (10 or 20 mg) to 22 subjects, 75 min before parabolic flight. Serum levels of ACTH, EPI, NE, and vasopressin (AVP) were unaltered by metoclopramide. AVP and ACTH (1.2 and 36 pg.ml-1) were elevated 77 and 3.8-fold (92.3 and 135 pg.ml-1) following emesis, after 40 parabolas (68.7 and 140 pg.ml-1) and landing (8.7 and 79 pg.ml-1). Seven subjects displaying no nausea and no emesis demonstrated smaller elevations (8.2 and 2.2-fold). Of 15 vomiting subjects, 7 reported no nausea and had lower elevations of AVP with faster recoveries. These findings are consistent with Rowe's suggestion (1979) that nausea may correlate with AVP release. Inhibition of AVP release by fluid shifts during microgravity might account for our findings and astronaut-reported episodes of vomiting without nausea. Elevations in EPI followed emesis or exposure to 40 parabolas whether emesis occurred or not. Only emesis elevated NE (578 to 840 pg.ml-1).

Adrenocorticotropic Hormone↗
PubMed1987

Nitrous oxide does not increase the incidence of nausea and vomiting after isoflurane anesthesia.

A total of 110 patients undergoing elective abdominal hysterectomy were anesthetized in random order with either isoflurane in nitrous oxide and oxygen or isoflurane in air and oxygen. Fentanyl was used as an adjunct to isoflurane in all patients, 0.05 mg every 45 min. No difference was found between the two anesthetic techniques in the incidence of nausea, vomiting, or both during the first 24 hr after operation. The overall incidence was 62 and 67% for air-O2 and N2O-O2 groups, respectively. Patients who had had nausea or vomiting after previous anesthetics had nausea or vomiting significantly more frequently than patients who did not. It is concluded that nitrous oxide does not contribute to the occurrence of nausea or vomiting after isoflurane anesthesia for gynecologic laparotomies.

Adult↗
PubMed1986

[Randomized cross-over study on the effects of methylprednisolone, metoclopramide and droperidol on the control of nausea and vomiting associated with cis-platinum chemotherapy].

A randomized cross-over study on the effects of methylprednisolone (MP), metoclopramide (MT) and droperidol (DP) on the control of nausea and vomiting associated with cis-platinum chemotherapy was performed. Sixty-three patients were entered into the study; 60 patients (21 treated with MP, 18 with MT and 21 with DP) were eligible for evaluation of antiemetic efficacy, whereas the side effects of these drugs were evaluated in all of the 63 patients. Out of the above 60 patients, 36 were entered into the cross-over treatment. Antiemetic efficacy was evaluated in terms of duration of nausea, duration of vomiting, frequency of vomiting, duration of inability to take food and the amount of food first taken after cis-platinum treatment. Generally, the MP-treated group of patients showed favorable effects in these points, MP being especially more effective than other drugs with a statistically significant difference for the control of nausea and disturbed intake of food during the first 24 hours after the treatment with CDDP. Anticipatory nausea and vomiting were not observed in this study. Side-effects were minimal and all of the patients except one, who showed severe diarrhea following administration of MT and could not tolerate the treatment thereafter, were safely treated.

Adult↗
PubMed1983

Levonantradol: a synthetic cannabinoid in the treatment of severe chemotherapy-induced nausea and vomiting resistant to conventional anti-emetic therapy.

Twenty-three patients with severe nausea and vomiting refractory to conventional anti-emetic therapy were entered into an open phase II study of levonantradol. Of 22 patients evaluable for response, three achieved complete relief from nausea and vomiting, seven obtained very good relief from nausea and vomiting, four obtained a partial reduction in nausea and vomiting, and eight obtained no relief. However all patients experienced side effects including, in particular, drowsiness and thought disturbance, and as a result eight patients had to be withdrawn from the study. There was no statistical patient preference for levonantradol over previous anti-emetic treatment. Levonantradol is an effective anti-emetic in approximately 50% of patients resistant to conventional anti-emetics; however, its usefulness is likely to be restricted by side effects which are common and frequently unpleasant.

Adult↗
PubMed1995

Improving patient-controlled analgesia: adding droperidol to morphine sulfate to reduce nausea and vomiting and potentiate analgesia.

Opioid-related side effects, including nausea and vomiting, are common in patients using morphine in patient-controlled analgesia for postoperative pain relief. The purpose of this study was to determine if the addition of droperidol to a morphine sulfate delivery system could decrease the incidences of nausea and vomiting without increasing droperidol-related side effects. Forty ASA 1 and 2 patients scheduled to undergo peripheral orthopedic surgery were randomized to receive either morphine sulfate (2 mg/mL), or morphine sulfate (1.9 mg/mL) plus droperidol (0.125 mg/mL) for postoperative self-controlled analgesia. Visual analogue scores for pain, nausea, and sedation were obtained from each patient immediately after surgery and each morning and evening until patient-controlled analgesia was discontinued approximately 48 hours later. Total patient-controlled use of morphine sulfate was recorded at each visual analogue rating. The patients who used morphine sulfate plus droperidol had significantly less nausea and vomiting and used significantly less morphine. No patient experienced droperidol-related side effects. We conclude that the routine addition of droperidol to morphine sulfate in self-controlled analgesia improves the comfort of patients following peripheral orthopedic surgery.

Analgesia, Patient-Controlled↗
PubMed1995

[Clinical phase III study of tropisetron capsule in the treatment of nausea and vomiting induced by carboplatin or non-platinum anti-cancer drugs].

A clinical phase III study of tropisetron capsule was conducted to assess its efficacy, safety and usefulness on nausea and vomiting induced by carboplatin or non-platinum anti-cancer drugs. The study was conducted in patients who experienced vomiting on previous chemotherapy. Tropisetron 5 mg capsule was given to patients once 2 hours prior to the first administration of either carboplatin or non-platinum anti-cancer drugs; the patients were then observed for nausea and/or vomiting during 24 hours after the first administration. Some 56.7% (17/30) of the patients did not vomit after tropisetron administration, and the frequency of vomiting was significantly reduced compared with that during the previous chemotherapy. Further, in the clinical efficacy ratings, in which the efficacy was assessed on the basis of the nausea and vomiting data, 83.3% (25/30) of cases were rated as "effective or better". Adverse events observed were 3 cases of mild headache, but these were not clinically problematic. The above results reveal that tropisetron capsule is significantly effective and safe in the treatment of nausea and vomiting induced by carboplatin or non-platinum anti-cancer drugs; in addition, tropisetron proved to be highly useful for its convenience as an oral agent.

Adult↗
PubMed1995

[Comparison of granisetron alone and granisetron plus dexamethasone or hydroxyzine hydrochloride for the prevention of nausea and vomiting during chemotherapy including cisplatin].

The comparative study among granisetron alone and granisetron combined with hydroxyzine hydrochloride or dexamethasone was undertaken for the prevention of nausea and vomiting during chemotherapy including cisplatin in patients with advanced head and neck carcinomas. The results indicated that the combination antiemetic therapies were more effective than granisetron alone for acute nausea and vomiting, whereas a significant difference was not observed among these three groups in the acute adverse effects. Otherwhile, there were statistically significant improvements in the prevention of delayed nausea and vomiting for patients receiving granisetron combined with the other antiemetic drugs, especially the combination antiemetic therapy with dexamethasone. These results confirm the antiemetic activity of granisetron in acute nausea and vomiting induced by cisplatin and show that it has an additive effect in combination with dexamethasone.

Adult↗
PubMed1993

Ondansetron, an antagonist of 5-HT3 receptors, in the treatment of antineoplastic drug-induced nausea and vomiting in children.

The aim of this study was to evaluate the efficacy and safety of ondansetron, an antagonist of 5-hydroxytryptamine type 3 (serotonin 3) (5-HT3) receptors, in controlling nausea and vomiting induced by antineoplastic therapy in children affected by cancer. Six patients affected by nausea and vomiting due to antineoplastic drugs were treated with ondansetron (4 mg/m2). Urinary samples for the assay of serotonin and 5-hydroxy-indoleacetic acid (5-HIAA) were collected 24 hr before antineoplastic drug treatment, 24 hours after the start of antineoplastic therapy and, 24 hr after the start of ondansetron therapy. All patients were affected by nausea and vomiting within two to four hr after the antineoplastic treatment. Urinary concentrations of serotonin and 5-HIAA were higher and statistically significant (P < 0.01) with respect to basal values. Treatment with ondansetron significantly reduced the number of episodes of nausea and vomiting, as well as the urinary values for serotonin and 5-HIAA.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1995

Optimal combination therapy with Navoban (tropisetron) in patients with incomplete control of chemotherapy-induced nausea and vomiting. The Belgian Navoban Group.

Even with the availability of potent and selective serotonin antagonists, chemotherapy-induced nausea and vomiting remain a major problem for many patients. This study aims to evaluate the benefit of combination therapy based on Navoban (tropisetron) in patients who had incomplete control of nausea and/or vomiting induced by chemotherapy when using Navoban as a single antiemetic agent. In their first chemotherapy course, 1072 patients planned to receive at least two identical cycles of emetogenic chemotherapy were treated with 5 mg Navoban once daily. To evaluate three treatments additional to the recommended 5 mg once-daily Navoban regimen during Course 2 in those patients who had shown incomplete control of nausea and/or vomiting on any day of Course 1, a 2 x 2 x 2 factorial design was employed. Of these patients, 445 were centrally randomised to receive an additional dose of open-label dexamethasone (Day 1, 0.2 mg/kg i.v.; Days 2-6, 8 mg p.o.) and/or open-label alizapride (Day 1, 100 mg i.v. and 4 x 50 mg p.o.; Days 2-6, 4 x 5 mg p.o.) and/or double-blind Navoban--that is, doubling the dose to 10 mg once daily or placebo. Complete response rates during Course 1 (CRR, no nausea and no vomiting) were, for Day 1, 72% and for Days 1-6, 48%. More complete responders were observed when dexamethasone was added during Course 2, both on Day 1 (76% vs. 66%, p = 0.020) and on Days 1-6 (50% vs. 34%, p = 0.0004).(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗
PubMed1994

[Ondansetron on postoperative nausea and vomiting].

The efficacy and safety of prophylactic intravenous ondansetron on prevention of postoperative nausea and vomiting were investigated in 65 ASA grades I-III patients undergoing elective abdominal surgery and receiving general anesthesia. Patients received ondansetron 4mg i.v. prior to a standardized technique for induction and intubation. Anesthesia was maintained with N2O-O2 and enflurane. The results showed that, by ondansetron 4mg, nausea and emesis could be significantly decreased. The effect lasted around 24h postoperatively without sedation. No one developed vomiting and only 9 patients developed nausea. No changes on laboratory parameters as well as vital signs were observed. No side-effects related to ondansetron were found. In prophylaxis of postoperative nausea and vomiting, ondansetron is effective and safe.

Abdomen↗
PubMed1994

Ondansetron: prevention of nausea & vomiting in cisplatin based chemotherapy.

Ondansetron in the prophylaxis of Cisplatin-induced emesis and nausea. The 5-HT3 antagonist ondansetron clearly offers a new approach to the control of Cisplatin-induced emesis and has been evaluated in Thailand. To evaluate anti-emetic efficacy of ondansetron in the prevention of nausea and vomiting induced by Cisplatin containing cancer chemotherapy regimen, we carried out an open multicentre study from January 1991 to December 1992. In this study, patients receiving Cisplatin based chemotherapy received ondansetron 32 mg as a single intravenous dose over 15 minutes prior to the administration of Cisplatin. This was followed by oral ondansetron 8 mg three times a day, preferably one hour before each meal for 5 days. All patients were chemotherapy naive in-patients and were at least 18 years or older with Karnofsky performance status of at least 60 per cent. The number of emetic episodes, nausea and food intake were recorded during the 24 hours following Cisplatin administration. A total of 103 patients were recruited with 84 (81.6%) evaluable patients (48 men and 36 women) scheduled to receive cisplatin chemotherapy at dose 60 mg/m2 or more (60-100 mg/m2), either as single agent or combination therapy. Complete response (complete control of emesis) was achieved in 60 per cent; major response (1-2 emetic episodes) was 13 per cent; minor response (3-5 emetic episodes) was 13 per cent; and failure (5+ emetic episodes) was 10 per cent. Side effects were very mild and not significant. We conclude that ondansetron is efficacious in protecting patients from Cisplatin induced emesis and nausea.

Adult↗
PubMed1993

Comparison of the combined effects of atropine and neostigmine with atropine and edrophonium on the occurrence of postoperative nausea and vomiting.

To investigate the effects of different types of anticholinesterase on the incidence of the postoperative nausea and vomiting, 100 ASA class I-II adult premenopausal female patients undergoing elective lower abdominal surgery were randomized into two groups. In both groups, anesthesia was induced with thiopental and fentanyl and 50% nitrous oxide and 0.5-1.5% of isoflurane were used for anesthetic maintenance with succinylcholine 1 approximately 1.5 mg/kg for intubation and atracurium 0.3 mg/kg/hr for maintenance of muscle relaxation. Patients received reversal agents for neuromuscular blockade after operation when the evoked train-of-four (TOF) count returned to four visual responses. A mixture of atropine 8 micrograms/kg and edrophonium 0.75 mg/kg was given to the first group of patients while atropine 15 micrograms/kg and neostigmine 40 micrograms/kg was given to another group of patients. All the patients were observed for the occurrence of nausea or vomiting for 2 hours after the operation in the recovery room. The incidence of nausea was not statistically significantly different in both groups (20% in neostigmine group and 26% in edrophonium group). The occurrence of vomiting was also similar in both groups (8% in neostigmine group and 6% in edrophonium group). We concluded that there were no difference in the incidence of postoperative nausea or vomiting with the use of either neostigmine or edrophonium with atropine for antagonizing neuromuscular blockade after the lower abdominal surgery.

Adult↗
PubMed1994

Oral ondansetron for preventing nausea and vomiting.

Available clinical data on the use of oral ondansetron for the prevention of nausea and vomiting in patients undergoing cancer chemotherapy or surgery are reviewed. Injectable ondansetron hydrochloride is very effective in preventing nausea and vomiting associated with even the most emetogenic antineoplastic drugs. In December 1992, 4- and 8-mg oral tablets (ondansetron hydrochloride dihydrate) became available. Many of the clinical trials of oral ondansetron have not compared it with other antiemetics or have compared it only with placebo. Oral ondansetron has shown efficacy in such trials, but the standard of care for preventing chemotherapy-induced emesis is not placebo. Studies involving a prechemotherapy i.v. dose of ondansetron followed by oral therapy have shown high response rates for the whole study period; however, when day 1 is excluded, the results are not impressive for the remainder of the study period. It seems that the period beyond 24 hours is when oral ondansetron is effective, and that efficacy against acute emesis is due to i.v. ondansetron. Clinical trials in which oral ondansetron and oral metoclopramide were compared showed ondansetron to be, at best, equal to metoclopramide. One study showed the combination of dexamethasone and metoclopramide to be superior to oral ondansetron. Oral ondansetron is more effective than placebo in preventing post-operative nausea and vomiting in gynecologic surgery patients; however, there have been no comparative studies, and routine use of antiemetics in most surgical patients may be unnecessary because newer anesthetics are less emetogenic. Although the adverse effects of oral ondansetron are milder than those of standard antiemetics, this may not compensate for the drug's high cost. Oral ondansetron is not superior to traditional antiemetics for the prevention of nausea and vomiting caused by chemotherapy or surgery.

Animals↗
PubMed1994

[Relationship between oral food intake and nausea caused by intravenous injection of iodinated contrast material].

From December, 1990 to July, 1992 we investigated the relationship between the time after oral food intake and nausea and vomiting caused by the intravenous injection of iodinated contrast media in 2,414 patients who underwent contrast enhanced CT. The contrast media used were as follows: amidotrizoic acid (high-osmolality contrast medium, HOCM, iodine 292 mg/ml) in 1173 patients, iopamidol (low-osmolality contrast medium, LOCM, iodine 300m g/ml) in 641 patients, and iohexol (LOCM, iodine 300 mg/ml) in 600 patients. All the patients had an intravenous injection of 100ml in volume. The overall incidence of nausea and vomiting was 3.8% (96/2412 patients). The incidence was 6. 7% (79/1173 patients) in the HOCM group and 1.4% (17/1241 patients) in the LOCM group. The incidence of nausea and vomiting increased with the interval between the oral intake of food and the intravenous injection of contrast medium. It is concluded that fasting before contrast-enhanced CT enhances the adverse effect of nausea and vomiting.

Adolescent↗