Prevention of postoperative nausea and vomiting with ondansetron: a prospective, randomized, double-blind study in 90 patients

Cortical variation in mammals and other terrestrial vertebrates, re-examined by current comparative methodology (out-group analysis), indicates that separate lateral (olfactory), dorsal and medial (hippocampal) pallial or cortical formations arose with the origin of vertebrates. Although the exact origin of mammalian isocortex (so-called neocortex) is still disputed, it appears that the earliest mammals already had a six-layered isocortex with ten to 20 functional subdivisions. Among placental mammals, at least, isocortex has expanded numerous times, producing additional cortical subdivisions. Because these expansions were independent transformations of a simpler cortex, they produced subdivisions that are not homologous.     

Sustained release metoclopramide for prophylaxis of post-operative nausea and vomiting

BACKGROUND: Eclampsia remains a serious complication of pregnancy and childbirth and factors related to morbidity require continued evaluation. DESIGN: Retrospective case-control study on the incidence and outcome of eclampsia. SETTING: A defined total island population over 20 years. METHODS: All centrally collected birth registration returns in Iceland for the years 1972-1991 were reviewed to identify women with the diagnosis of eclampsia, selecting women delivering immediately before and after the eclamptic case as controls. Information from all places where women had delivered was obtained to ensure that no case was missed. Maternity records were reviewed to verify the diagnosis and obtain maternal and neonatal data. RESULTS: Forty women had eclampsia (0.046% of deliveries). The incidence diminished between the decades 1972-81 and 1982-91 (p < 0.05), as did the incidence of eclamptic convulsions before delivery. Eclamptic women were more often primiparous, younger and delivered earlier than controls. Preterm delivery and a low ponderal index were more common among offspring of the eclamptic mothers and the male/female ratio was lower. CONCLUSION: The incidence of eclampsia in the population is falling. Common features related to the condition were confirmed. Severe maternal illness is rare, but the babies often appear growth-retarded and are delivered preterm.     

Tropisetron or ondansetron compared with placebo for prevention of postoperative nausea and vomiting

In a prospective, randomized, double-blind, placebo-controlled, multicentre study, the efficacy of prophylactic tropisetron (2 mg) or ondansetron (4 mg) for the prevention of post-operative nausea and vomiting after abdominal or non-abdominal surgery with general balanced anaesthesia was studied in 842 ASA I-III patients. In patients undergoing abdominal surgery, ondansetron and tropisetron reduced the frequency of emetic episodes compared with the placebo (29%, 30% vs. 42% respectively). In men, neither tropisetron nor ondansetron had an effect different from the placebo, whereas in women both drugs led to lower rates of emetic episodes and nausea. In comparison with abdominal surgery, fewer patients in the non-abdominal surgery subgroup had emetic episodes (42% vs. 23% in the placebo group). However, neither tropisetron nor ondansetron was significantly different from the placebo in this patient subgroup. In conclusion, for patients at increased risk of post-operative nausea and vomiting, a prophylactic therapy at the lowest effective dose with tropisetron or ondansetron may be useful.     

Efficacy of ondansetron in radiation-induced nausea and vomiting: review of the literature

Radiotherapy-induced emesis depends on the site of irradiation, the field size and the dose per fraction and is generally less intense than chemotherapy-induced emesis. Established anti-emetic drugs offer only limited symptom control (50%). Ondansetron, a 5HT3 receptors antagonist, had proven a complete or a major control efficacy (0-2 emetic episodes) of 68 to 95% in three pilot studies (fractionated, single-dose and total body irradiations). In controlled studies, ondansetron efficacy was significantly higher than placebo, metoclopramide and prochlorperazine. The treatment was well tolerated in the different studies.     

Intravenous dolasetron and ondansetron in prevention of postoperative nausea and vomiting: a multicenter, double-blind, placebo-controlled study

BACKGROUND: Intravenous dolasetron mesilate has shown efficacy in the prevention of postoperative nausea and vomiting (PONV) when administered as a single dose prior to emergence from anesthesia. This trial compared intravenous dolasetron and ondansetron for the prevention of PONV when administered at induction of anesthesia. METHODS: This double-blind, placebo-controlled, multicenter trial randomized patients to one of four single IV treatments placebo, 25 or 50 mg dolasetron, or 4 mg ondansetron. Efficacy was measured by complete response (0 emetic episodes and no rescue medication), nausea severity and patient satisfaction as measured on a visual analog scale (VAS), investigator's rating, of nausea severity, and total response (complete response with no nausea [< or = 5 mm VAS]). RESULTS: 514 patients at 24 sites were evaluated for efficacy. The 50 mg dolasetron and 4 mg ondansetron doses were statistically equivalent, and superior to placebo, for all efficacy measures. Complete response rates were 49%, 51%, 71% and 64% for placebo, 25 and 50 mg dolasetron, and ondansetron, respectively. Dolasetron 50 mg was statistically superior to 25 mg dolasetron for complete response, total response, VAS maximum nausea, time to first emetic episode, and patient satisfaction. The majority of adverse events were of mild-to-moderate intensity. Headache was the most frequently reported treatment-related adverse event with a 3%-5% incidence across treatments. CONCLUSION: When given at induction of anesthesia, 50 mg intravenous dolasetron is equivalent to 4 mg ondansetron and superior to 25 mg dolasetron and placebo for the prevention of PONV. All treatments were safely administered and well tolerated.     

Efficacy of ondansetron in prophylaxis of postoperative nausea and vomiting in patients following infratentorial surgery: a placebo-controlled prospective double-blind study

Competitive PCR was used to monitor the survival of a 520-bp DNA target sequence from a recombinant plasmid, pVACMC1, after admixture of the plasmid with freshly sampled human saliva. The fraction of the target remaining amplifiable ranged from 40 to 65% after 10 min of exposure to saliva samples from five subjects and from 6 to 25% after 60 min of exposure. pVACMC1 plasmid DNA that had been exposed to degradation by fresh saliva was capable of transforming naturally competent Streptococcus gordonii DL1 to erythromycin resistance, although transforming activity decreased rapidly, with a half-life of approximately 50 s. S. gordonii DL1 transformants were obtained in the presence of filter-sterilized saliva and a 1-microg/ml final concentration of pVACMC1 DNA. Addition of filter-sterilized saliva instead of heat-inactivated horse serum to S. gordonii DL1 cells induced competence, although with slightly lower efficiency. These findings indicate that DNA released from bacteria or food sources within the mouth has the potential to transform naturally competent oral bacteria. However, further investigations are needed to establish whether transformation of oral bacteria can occur at significant frequencies in vivo.     

Post-laparoscopic vomiting in females versus males: comparison of prophylactic antiemetic action of ondansetron versus metoclopramide

PURPOSE: To evaluate the clinical usefulness of the continuous intra-arterial blood gas (CIABG) monitoring system, Paratrend 7, during differential lung ventilation (DLV) in 12 patients undergoing oesophagectomy. METHODS: Anaesthesia was induced with propofol and was maintained with isoflurane, oxygen and air, supplemented by an epidural infusion of mepivacaine. Arterial samples for estimation of blood gases (ABG) were taken just before and 5, 10, 20, 30, 60, and 90 min after the pleura was opened. The pH, PO2, and PCO2 values displayed by the CIABG monitor, which were recorded prior to the arterial blood sampling, were compared with the results of ABG analysis. RESULTS: Eighty-four blood samples were obtained and the ranges for the measured variables were PCO2 24.8-57.4 mmHg, PO2 47-449 mmHg, and pH 7.30-7.49. The correlation between CIABG and ABG measurements was strong and significant (r values: PCO2 0.80, PO2 0.93, pH 0.94). The overall bias +/- precision between the two methods was PCO2 0.9 +/- 3.1 mmHg, PO2 -1 +/- 40 mmHg, %PO2 0.8 +/- 21.6%, pH 0.00 +/- 0.02. For PO2 values < 150 mmHg, the biases +/- precision were PO2 -5 +/- 17 mmHg, %PO2 -2.1 +/- 20.7%. CONCLUSION: The agreement between CIABG and ABG measurements was better for PCO2 and pH than for PO2. Although the CIABG system is clinically useful for monitoring trends in blood gas changes, the accuracy of the PO2 value may be unacceptable during DLV because the error is theoretically < 34 mmHg with 95% reliability in the clinically important range of PO2, < 150 mmHg.     

Control of nausea and vomiting with ondansetron in patients treated with intensive non-cisplatin chemotherapy for acute myeloid leukaemia

18 consecutive patients with acute myeloid leukaemia (AML) treated with 34 cycles of intensive chemotherapy received ondansetron as antiemetic treatment. 14 patients were chemotherapy-naive, while 4 patients were treated for relapsed leukaemia. All patients received at least one cycle of chemotherapy, 11 patients (61%) received two cycles and 5 patients (28%) received three cycles. The remission induction regimen consisted of cytarabine 200 mg/m2 daily from day 1 to day 7, in combination with an anthracycline or amsacrine on 3 days. During the second and third cycle the dose of cytarabine was increased. Ondansetron was administered as follows: 8 mg intravenously before the start of chemotherapy, followed by 8 mg orally three times daily for 10 days. 50% of patients had no episodes of vomiting during the first cycle of chemotherapy and 78% had less than five episodes of vomiting over 10 days. 72% of patients had no or only mild nausea. These high response rates were maintained during the subsequent cycles. No side-effects due to ondansetron were registered. These data indicate that ondansetron is efficacious in preventing nausea and vomiting in patients with AML treated with intensive chemotherapy.     

Prevention of nausea and vomiting in female patients undergoing breast surgery: a comparison with granisetron, droperidol, metoclopramide and placebo

Centromerically located alphoid satellite DNAs are present in all primates. They typically consist of arrays of a 340-bp monomeric unit that is composed of related, but diverged, 170-bp subunits. A unique monomeric unit has recently been described: the alphoid satellite monomers of the neotropical primate Chiropotes satanas (bearded saki) are typically 539 bp in length. In addition, a number of smaller satellite sequences are present in this species. Analysis of two primates closely related to Chiropotes, Pithecia irrorata (saki) and Cacajao melanocephalus (uakari), show that they also contain unique alphoid satellites that are different from those of Chiropotes and different from one another. Southern blot and sequence analyses suggest that an alphoid satellite rearrangement(s) occurred early in the history of the tribe Pitheciini (Chiropotes, Pithecia, Cacajao) and that rearrangements are continuing to occur in this group of primates.     

Continuous-infusion granisetron compared to ondansetron for the prevention of nausea and vomiting after high-dose chemotherapy

OBJECTIVES: The main aim was to calculate the prevalence of mental pathology in women between 18 and 70 in a Health District of Pamplona; second, to describe comorbidity and to analyse how mental pathology was recorded in the clinical histories. DESIGN: An observational crossover study with randomised selection. SETTING: A community study in the Txantrea quarter of Pamplona, covering 21,590 inhabitants, with 7605 women between 18 and 70. PATIENTS: Randomised sample, stratified by age, of 237 women between 18 and 70 taken from the 1991 Census. MEASUREMENTS AND RESULTS: In a face-to-face interview at the Health Centre, the DIS Questionnaire, which diagnoses mental illness, was administered to all participants. A check was made to see if mental pathology was recorded in their clinical history. The prevalence of mental illnesses, mainly Phobias and Depression, in the "last year of life" was 33.3% (27.5-39.5), which fell to 24.9% (19.7-30.7) when tobacco abuse was excluded. The most common pathologies were: Depression (17.3%), Tobacco dependency (17.3%), simple Phobia (14.8%), Agoraphobia (13.5%), social Phobia (8.9%) and post-traumatic stress (8.0%). CONCLUSIONS: Understanding the high psychological morbidity in these urban women can contribute to the development of Mental Health Promotion and Prevention Programmes and foment fuller mental health training for Primary Care professionals.     

Does oral ondansetron reduce the incidence of nausea and vomiting after surgery for strabismus in children?

OBJECTIVE: To compare the efficacy of oral ondansetron with oral metoclopramide for the prevention of postoperative vomiting and nausea in children undergoing strabismus surgery. STUDY DESIGN: Prospective, randomized, double-blind trial. PATIENTS: Thirty children of physical class 1, age 9 +/- 4 years, scheduled for strabismus surgery, were randomized into two groups (ondansetron and metoclopramide). METHODS: In the ondansetron group, the children received the first oral dose of ondansetron (4 mg) 1 hour before induction of anaesthesia and the other doses 8 and 16 hours later. In the metoclopramide group, children received metoclopramide (5 mg) in the same conditions. Anaesthesia was induced with thiopentone, vecuronium and fentanyl and maintained with halothane and N2O/O2. Patients were evaluated by an independent observer for nausea and emesis in recovery room (0-2 h) and on the ward. The adverse effects of oral ondansetron and metoclopramide were assessed. RESULTS: There were non-significant differences between the two groups for incidence of nausea and vomiting (40% and 53% in ondansetron group versus 33 and 60% in metoclopramide group, respectively. CONCLUSION: Unlike intravenous ondansetron, oral ondansetron is not superior to metoclopramide for the prevention of nausea and vomiting caused by strabismus surgery in children.     

Efficacy, dose-response, and safety of ondansetron in prevention of postoperative nausea and vomiting: a quantitative systematic review of randomized placebo-controlled trials

OBJECTIVE: The authors reviewed efficacy and safety data for ondansetron for preventing postoperative nausea and vomiting (PONV). METHODS: Systematically searched, randomized, controlled trials (obtained through MEDLINE, EMBASE, Biological Abstracts, manufacturer's database, manual searching of journals, and article reference lists) were analyzed. Relevant end points were prevention of early PONV (within 6 h after surgery) and late PONV (within 48 h) and adverse effects. Relative benefit and number-needed-to-treat were calculated. The number-needed-to-treat indicated how many patients had to be exposed to ondansetron to prevent PONV in one of them who would have vomited or been nauseated had he or she received placebo. RESULTS: Fifty-three trials were found that had data from 7,177 patients receiving 24 different ondansetron regimens and from 5,712 controls receiving placebo or no treatment. Average early and late PONV incidences without ondansetron were 40% and 60%, respectively. There was a dose response for oral and intravenous ondansetron. Best number-needed-to-treat to prevent PONV with the best documented regimens was between 5 and 6. This was achieved with an intravenous dose of 8 mg and an oral dose of 16 mg. Antivomiting efficacy was consistently better than antinausea efficacy. Efficacy in children was poorly documented. Ondansetron significantly increased the risk for elevated liver enzymes (number-needed-to-harm was 31) and headache (number-needed-to-harm was 36). CONCLUSIONS: If the risk of PONV is very high, for every 100 patients receiving an adequate dose of ondansetron 20 patients will not vomit who would have vomited had they received placebo. The antinausea effect is less pronounced. Of these 100, three will have elevated liver enzymes and three will have a headache who would not have had these adverse effects without the drug.     

Prevention of nausea and vomiting with granisetron, droperidol and metoclopramide during and after spinal anaesthesia for caesarean section: a randomized, double-blind, placebo-controlled trial

OBJECTIVE: To compare the safety and efficacy of a combination of amoxicillin and clavulanate potassium given orally every 12 hours (amoxicillin, 875 mg; clavulanate, 125 mg) with that given every 8 hours (amoxicillin, 500 mg; clavulanate, 125 mg) for the treatment of patients with acute bacterial maxillary sinusitis. DESIGN: Multicenter double-blind randomized double-dummy controlled trial. SETTING: Physicians' offices and ambulatory care clinics. PATIENTS: One hundred seventy patients at least 18 years of age with acute bacterial maxillary sinusitis who could be treated with an oral antimicrobial agent were randomized, and data from 134 were suitable for evaluation. Four patients were withdrawn from this study because of adverse effects. INTERVENTIONS: Patients received a combination of amoxicillin and clavulanate orally every 12 hours (amoxicillin, 875 mg; clavulanate, 125 mg) or every 8 hours (amoxicillin, 500 mg; clavulanate, 125 mg) for 14 days. MAIN OUTCOME MEASURE: Clinical success at the end of therapy. RESULTS: Clinical success at the end of therapy was similar for the 2 treatment groups, 93% and 88% of patients in the every 12-hour and every 8-hour groups, respectively (P = .76; 95% confidence interval, -4.0% to 15.6%). Clinical success rates at follow-up 2 to 4 weeks after the end of therapy were also similar in the 2 groups. Adverse events related to treatment were reported with similar frequency in the 2 groups. CONCLUSION: Amoxicillin and clavulanate given every 12 hours is as effective and as safe as administration every 8 hours for the treatment of acute bacterial maxillary sinusitis.     

Effect of concurrent use of ondansetron hydrochloride and dexamethasone against nausea and vomiting in lung cancer patients receiving cisplatin

We examined the efficacy of concurrent use of ondansetron hydrochloride and dexamethasone, and the effective dose of dexamethasone against nausea and vomiting in lung cancer patients receiving chemotherapy including single high dose cisplatin. The study was carried out on total of 44 courses of chemotherapy in either initial onset or recurrence of lung cancer. The patients were given 4 mg of ondansetron injection on the day of cisplatin injection (Day 1), and 4 mg/day of ondansetron tablet for Days 2 to 4. These patients were randomly allocated into 2 groups, i.e., those who, on Day 2, concomitantly received 10 mg of dexamethasone (D10 Group, 22 courses) or 20 mg (D20 Group, 22 courses), for comparing the antiemetic effects in a different concomitant dose of dexamethasone. An efficacy rate of 70% or more was achieved in each group for acute emesis on Day 1. The efficacy rate was 80% or above for emesis on Day 2 when dexamethasone was concurrently administered, and Days 3 and 4 in both groups. No significant difference was observed between the groups. A higher complete suppression rate against nausea was seen in D20 Group even though the difference from D10 Group was not significant. Furthermore, food intake rate on Day 2 was significantly better in D20 Group. However, in the cases that were graded effective or markedly effective for acute emesis on Day 1, the efficacy rate was also high in both groups through Days 2-4. It was notable that the efficacy rate of Days 2-4 was 100% in D2 Group. The high efficacy rate was shown in male patients regardless of which dose of dexamethasone was used. However, control of emesis was unfavorable in female patients on Day 1 and was still unfavorable even though dexamethasone was combined from Day 2. We considered from the above results that 10 mg/day of concurrent dexamethasone is sufficient in suppression of delayed emesis on Day 2. However, in order to improve nausea or food intake, or to suppress emesis in patients who are highly likely to show unfavorable control for Day 2 and onward, 20 mg/day should also be effective.     

Antiemetic prophylaxis after laparoscopic cholecystectomy: comparative study of dehydrobenzperidol, metoclopramide, ondansetron and placebo

OBJECTIVES: To compare the efficacy of ondansetron to that of metoclopramide, dehydrobenzperidol and placebo for the prevention of postoperative nausea and vomiting (PONV) after laparoscopic cholecystectomy in a double-blind random study. PATIENTS AND METHOD: A total of 100 ASA I, II and III patients undergoing scheduled laparoscopic cholecystectomy were divided into 4 groups according to whether they received one of the following intravenously just prior to anesthetic induction: 1.25 mg dehydrobenzperidol (group D), 10 mg metoclopramide (group M), 4 mg ondansetron (group O) or 2 ml of saline (group P). All received general anesthesia with induction by thiopental, analgesia with fentanyl, muscle relaxation with atracurium and maintenance with oxygen-air and isoflurane. Episodes of nausea and/or vomiting during the first 24 h after surgery were recorded. Treatment was considered effective if no episodes occurred during this period. RESULTS: Nine of the 100 patients were excluded from the study. There were no significant differences in demographic variables among the 4 groups. The incidence of PONV was significantly greater in group P than in any of the other groups. There were no significant differences in PONV among groups D, M and O. CONCLUSIONS: Ondansetron provides safe, effective prophylaxis for PONV after laparoscopic cholecystectomy, but it is not superior to the antiemetic drugs usually used. Its use may be justified in patients in whom dehydrobenzperidol or metoclopramide are contraindicated.     

Comparison of single-dose oral granisetron versus intravenous ondansetron in the prevention of nausea and vomiting induced by moderately emetogenic chemotherapy: a multicenter, double-blind, randomized parallel study

PURPOSE: The antiemetic effectiveness and safety of single-dose oral granisetron were compared with intravenous (I.V.) ondansetron in chemotherapy-naive patients who received moderately emetogenic chemotherapy. PATIENTS AND METHODS: In this double-blind, parallel-group study, patients naive to emetogenic chemotherapy (N = 1,085) who were scheduled to receive cyclophosphamide- (500 to 1,200 mg/m2) or carboplatin (> or = 300 mg/m2) based chemotherapy, were randomized to receive either oral granisetron (n = 542) or I.V. ondansetron (n = 543). Efficacy assessments included the proportion of patients in each treatment group with total control over the 24 and 48 hours following chemotherapy initiation, as well as incidence and severity of nausea and emesis and use of antiemetic rescue medication. Prophylactic corticosteroids were allowed. Safety assessment was based on patients' reports of adverse experiences. RESULTS: Approximately 80% of patients received prophylactic corticosteroids. Single-dose oral granisetron (2 mg) and I.V. ondansetron (32 mg) resulted in equivalent levels of total emetic control during the first 48 hours after chemotherapy. The proportion of nausea- and emesis-free patients at 24 and 48 hours were also approximately equivalent. The most commonly reported adverse experiences were headache, asthenia, and constipation. More patients who received ondonsetron than granisetron reported dizziness (9.6% v 5.4%, respectively; P = .011) and abnormal vision (4.2% v 0.6%, respectively; P < .001). CONCLUSION: A single oral dose of granisetron (2 mg) resulted in equivalent levels of antiemetic protection as I.V. ondansetron (32 mg). Both agents were well tolerated, although more dizziness and abnormal vision were reported with ondansetron. Because the two antiemetic regimens exhibited equivalent efficacies, additional factors such as convenience and cost of therapy should be considered.     

Patients' self-reported functional status after granisetron or ondansetron therapy to prevent chemotherapy-induced nausea and vomiting at six cancer centers

Patient functional status after administration of either granisetron or ondansetron to prevent acute chemotherapy-induced nausea and vomiting (CINV) was studied. Pharmacists and nurses from six cancer centers distributed Functional Living Index-Emesis (FLIE) questionnaires to 115 outpatients receiving either granisetron or ondansetron for prevention of CINV. The emetogenic potential of each patient's chemotherapy regimen was high, moderately high, or moderate. Immediately before and 72 hours after chemotherapy, each patient rated his or her reaction to each of 18 items on the questionnaire on a 7-point scale. Possible scores ranged from 18 to 126, with higher scores indicating higher levels of functioning. The occurrence of nausea in the granisetron group was 40.0% compared with 43.2% in the ondansetron group; the occurrence of vomiting was 18.8% in the granisetron group and 11.1% in the ondansetron group. Patients who received highly emetogenic chemotherapy had significantly lower scores on the FLIE after chemotherapy than before. Patients with both nausea and vomiting reported a much higher negative impact on functional status after chemotherapy than those with nausea only. The mean prechemotherapy and postchemotherapy FLIE scores were 124.2 and 110.4 for granisetron and 124.9 and 111.9 for ondansetron. Granisetron and ondansetron did not differ significantly in their effect on functional status reported by patients before and 72 hours after receiving cancer chemotherapy.     

An open multicentre study of tropisetron for cisplatin-induced nausea and vomiting

1. P2X-receptors are ligand-gated ion channels which activate within milliseconds of agonist binding, causing rapid cellular depolarization and excitation. This makes them ideally suited to mediate the rapid neurotransmitter functions of adenosine 5'-triphosphate (ATP). 2. The initial postjunctional response of the vas deferens and most blood vessels to sympathetic nerve stimulation is a rapid, transient excitatory junction potential (EJP). With sufficient stimulation EJPs summate and the membrane depolarizes sufficiently to open voltage-dependent calcium channels, initiating a calcium action potential and contraction. 3. EJPs are inhibited by desensitization of the P2X-receptor by the stable agonist alpha, beta-methyleneATP (alpha, beta-meATP) and by the P2X-receptor antagonists ANAPP3, suramin and pyridoxalphosphate-6-azophenyl-2',4'-disulphonic acid, indicating that they are consequent upon activation of the P2X-receptor. 4. The P2X-receptor was originally defined by contractile studies in smooth muscle preparations, where a rank order of agonist potency of alpha, beta-meATP > > 2-methylthioATP (2-meSATP) > or = ATP was found. However, recent results show that the potency of ATP and 2-meSATP, but not alpha, beta-meATP, is decreased by 100-to 1000-fold by breakdown and when this is prevented, ATP and 2-meSATP are more potent than alpha, beta-meATP as agonists at the P2X-receptor. 5. This conclusion was supported by the cloning and functional expression of the P2X1-receptor from the rat bladder. A total of seven P2X-subunits have since been cloned and the P2X1-subunit is thought to be the predominant subunit expressed in vascular smooth muscle cells.     

Treatment of postoperative nausea and vomiting with single intravenous doses of dolasetron mesylate: a multicenter trial. Dolasetron Mesylate PONV Treatment Study Group

This study was conducted to determine the efficacy and safety of four intravenous (I.V.) doses of dolasetron, an investigational 5-HT3 receptor antagonist, for the treatment of postoperative nausea and/or vomiting (PONV) after outpatient surgery under general anesthesia. This multicenter, randomized, double-blind trial compared the antiemetic efficacy of 12.5, 25, 50, or 100 mg I.V. dolasetron with placebo over 24 h using complete response (no emetic episodes and no rescue medication), time to first emetic episode or rescue medication, and patient nausea and satisfaction with antiemetic therapy as rated by visual analog scale (VAS). Of 1557 patients enrolled, 620 patients were eligible for treatment. Complete response rates for all dolasetron doses--12.5 mg (35%), 25 mg (28%), 50 mg (29%), and 100 mg (29%)--were significantly more effective than placebo (11%, P < 0.05). There was a significant gender interaction for complete response (P < 0.01). Of the patients in the 25-mg and 100-mg dose groups, 12% and 13%, respectively, experienced no nausea (VAS score < 5 mm) versus 5% in the placebo group (P < 0.05). There were no clinically relevant changes in vital signs or laboratory values and no trends with dose for adverse events. Dolasetron is effective for treating PONV and has an adverse event profile similar to that of placebo. The 12.5-mg dose was as effective as larger doses for complete response. IMPLICATIONS: Nausea and vomiting are common problems for postsurgical patients. In this study of 620 patients undergoing surgery, a 12.5-mg dose of intravenous dolasetron, a new serotonin-receptor blocker, was significantly more effective than placebo in treating established postoperative nausea and vomiting. Dolasetron 12.5 mg was as safe as placebo.     

Ondansetron for prevention of postoperative nausea and vomiting following minor oral surgery: a double-blind randomized study

The efficacy and safety of ondansetron in preventing postoperative nausea and vomiting following minor oral surgery was evaluated in a prospective randomized double-blind study. Of a total of seventy-seven patients, randomly 38 had 4 mg of ondansetron and 39 had normal saline as placebo intravenously immediately prior to induction of anaesthesia. A standard general anaesthetic with thiopentone, suxamethonium, fentanyl, nitrous oxide and isoflurane was employed. Postoperatively nausea was assessed verbally and on a visual analog scale at 1, 4 and 24 hours from the time of awakening. Episodes of vomiting were recorded. Eight patients (21.1%) in the ondansetron group compared to 19 (48.7%) in the placebo group had nausea (P < 0.05) and 1 (2.6%) in the ondansetron group compared with 9 (23.1%) in the placebo group vomited (P < 0.05). Patients who vomited twice or more and the number who required a rescue antiemetic were significantly fewer in the ondansetron group (P < 0.05). Cardiovascular parameters were stable and showed no significant difference in the two groups. There were no significant adverse effects that could be directly attributable to ondansetron.