Comparison of Ondansetron Versus Placebo to Prevent Postoperative Nausea and Vomiting in Women Undergoing Ambulatory Gynecologic Surgery

McKenzie, Ray; Kovac, Anthony L.; O’Connor, Thomas A.; Duncalf, Deryck; Angel, Jessie; Gratz, Irwin; Tolpin, Eugene; McLeskey, Charles H.; Joslyn, Alan F.

doi:10.1097/00000542-199301000-00005

Cited by 292 publications

(84 citation statements)

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“…2 8 The 4 mg dose of ondansetron was chosen as it is considered the optimal dose for prophylaxis of PONV. 29,30 The lack of difference in requests for "rescue" medication between placebo and each of the anti-emetic drug groups alone emphasizes the need for an alternative to single dose single antiemetic therapy for the prophylaxis of PONV -combination anti-emetic therapy.…”

Section: Discussionmentioning

confidence: 99%

Additive anti-emetic efficacy of prophylactic ondansetron with droperidol in out-patient gynecological laparoscopy

Belo

Koutsoukos

2000

Can J Anesth/J Can Anesth

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Purpose: To determine the efficacy of ondansetron and droperidol, alone and in combination, administered for prophylaxis of postoperative nausea and vomiting (PONV) in women undergoing general anesthesia for outpatient gynecological laparoscopy.Methods: Following Institutional Ethics Board approval and patient consent, 160 female out-patients scheduled for laparoscopy were randomly allotted in a double-blind fashion to receive: i) saline (placebo), ii) 4 mg ondansetron, iii) 1.25 mg droperidol, or iv) 4 mg ondansetron and 1.25 mg droperidol combination intravenously on induction. Following a standardized general anesthesia, patients were interviewed and assessed for PONV at various times.Results: During the first 24 hr after surgery, the incidence of PONV in the placebo group was 71%. This was reduced to 61% with droperidol alone (P = 0.334), to 46% with ondansetron alone (P = 0.027), and to 23% with the combination group (P < 0.001). A statistically significant difference was observed between combination and droperidol (P < 0.001) and between combination and ondansetron (P = 0.036). There were fewer requests for rescue medication from the combination group (7.7%) than from the ondansetron and placebo groups. Conclusion:The results of this study suggest that the combination of 4 mg ondansetron and 1.25 mg droperidol is more efficacious as a prophylactic anti-emetic than either agent alone during the 24 hr post-surgery. This additive effect may be due to the different mechanisms of action of ondansetron and droperidol.Objectif : Déterminer l'efficacité de l'ondansétron et du dropéridol, seuls ou combinés, administrés comme prophylaxie des nausées et vomissements postopératoires (NVPO) chez des patientes sous anesthésie générale lors d'une laparoscopie gynécologique en clinique externe.Méthode : Après avoir obtenu l'autorisation du Comité d'éthique médicale et le consentement des patientes, on a procédé à l'étude de 160 femmes, réparties au hasard en double aveugle, qui ont reçu avant la laparoscopie ambulatoire prévue : i) une solution salée (placebo), ii) 4 mg d'ondansétron, iii) 1,25 mg de dropéridol, ou iv) une combinaison intraveineuse de 4 mg d'ondansétron et de 1,25 mg de dropéridol à l'induction de l'anesthésie. Après l'anesthésie générale standard, les patientes ont été interrogées sur les NVPO à différents temps.Résultats : Pendant les 24 premières heures postopératoires, l'incidence des NVPO ont été de 71 % dans le groupe placebo. Cette incidence a été réduite à 61% avec de dropéridol employé seul (P = 0,334), à 46 % avec l'ondansétron seul (P = 0,027) et à 23 % avec la combinaison des deux médicaments (P < 0,001). Une différence statistiquement différente a été observée entre la combinaison et le dropéridol (P < 0,001) et entre la combinaison et l'ondansétron (P = 0,036). On enregistre moins de demandes de médication de rattrapage provenant des patientes qui ont reçu la combinaison de médicaments (7,7 %) que de celles qui ont reçu l'ondansétron ou le placebo.Conclusion : Les résultats de l'étude suggèr...

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Section: Discussionmentioning

confidence: 99%

Additive anti-emetic efficacy of prophylactic ondansetron with droperidol in out-patient gynecological laparoscopy

Belo

Koutsoukos

2000

Can J Anesth/J Can Anesth

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“…A single dose of intravenous ondansetron 4 mg has also been shown to be effective and well tolerated in preventing and treating established PONV [5,6]. Two further studies were undertaken to examine whether a single oral dose of ondansetron would be effective in preventing PONV both in patients with and without a previous history of PONV undergoing gynaecological and non-gynaecological surgery.…”

Section: Introductionmentioning

confidence: 99%

Single oral dose ondansetron in the prevention of postoperative nausea and emesis

Rust¹,

Cohen²

1994

Anaesthesia

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SummaryIn two placebo-controlled, double-blind, multicentre 0.007; nausea p Key wordsPharmacology; ondansetron, oral formulation. Complications; nausea and vomiting. Receptors; 5-HT3. Vomiting; antiemetics, prophylaxis.Postoperative nausea and vomiting (PONV) are among the most common complications that occur after surgery performed under general anaesthesia, with female patients being particularly susceptible [ 11. Other factors, including a previous history of PONV and the site of surgery, are thought to influence the occurrence of these problems [2].In two earlier studies, a three-dose oral regimen of ondansetron 8 mg has been shown to be effective and well tolerated in preventing PONV [3,4]. A single dose of intravenous ondansetron 4 mg has also been shown to be effective and well tolerated in preventing and treating established PONV [5,6]. Two further studies were undertaken to examine whether a single oral dose of ondansetron would be effective in preventing PONV both in patients with and without a previous history of PONV undergoing gynaecological and non-gynaecological surgery. The studies also aimed to identify the optimum dose of ondansetron in terms of efficacy and safety. MethodBoth studies were double-blind, placebo-controlled, and multicentre, with one being performed in 34 centres across nine European countries

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“…Ondansetron has also been shown to be effective in the prevention [4] and treatment [5] of PONV. The results of three large multicentre, randomised, double-blind, placebo-controlled trials, examining the safety and efficacy of single dose intravenous prophylactic ondansetron in male and female patients, are presented here.…”

mentioning

confidence: 99%

Single dose intravenous ondansetron in the prevention of postoperative nausea and vomiting

Pearman

1994

Anaesthesia

137

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Despite significant advances in the delivery of general anaesthesia, postoperative nausea and vomiting (PONV) continue to be "the big 'little problem' for surgical patients", as described in a recent editorial [I]. Certain patient-related factors (gender, obesity, or history of motion sickness), surgical procedures (laparoscopy, strabismus surgery, or middle ear surgery), and anaesthetic techniques (nitrous oxide, narcotics, or inhalational agents) may affect the incidence of PONV [2]. As more and more surgery is being performed on a day case basis, the need for effective antiemetics, with fewer side effects than those currently in use, is becoming more urgent. Prophylactic antiemetic therapy in patient populations at high risk for PONV may not only be beneficial but also cost-effective if unanticipated hospital admissions for P O W can be avoided.Ondansetron, a 5-hydroxytryptamine subtype 3 (5-HT,) receptor antagonist, is an effective antiemetic in the prevention of chemotherapy-induced emesis [3]. Ondansetron has also been shown to be effective in the prevention [4] and treatment [5] of PONV. The results of three large multicentre, randomised, double-blind, placebo-controlled trials, examining the safety and efficacy of single dose intravenous prophylactic ondansetron in male and female patients, are presented here. MethodWritten informed consent was obtained from all patients after approval of the protocols by the Institutional Review Board at each centre. In study 1, 580 ASA grade 1 or 2 female patients, aged 18-70 years, scheduled to undergo gynaecological laparoscopy on a day case basis, were enrolled. Five hundred and eighty-nine female patients, aged 18-70 years, scheduled to undergo day case surgery, were enrolled in study 2. In study 3,468 ASA grade 1 or 2 male patients, over 12 years of age, scheduled to undergo surgery on a day case basis, were enrolled. Patients who had vomited or received antiemetics within 24 h of surgery, were pregnant or breastfeeding (studies 1 and 2), were scheduled to undergo liver biopsy, required continuous gastric suction intraoperatively, or were greater than 100% over ideal body weight were not studied.Patients in all three studies were stratified into two groups: patients with a history of PONV after general anaesthesia, and patients with no history of PONV or no

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Comparison of Ondansetron Versus Placebo to Prevent Postoperative Nausea and Vomiting in Women Undergoing Ambulatory Gynecologic Surgery

Cited by 292 publications

References 0 publications

Additive anti-emetic efficacy of prophylactic ondansetron with droperidol in out-patient gynecological laparoscopy

Additive anti-emetic efficacy of prophylactic ondansetron with droperidol in out-patient gynecological laparoscopy

Single oral dose ondansetron in the prevention of postoperative nausea and emesis

Single dose intravenous ondansetron in the prevention of postoperative nausea and vomiting

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