A Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Three Different Doses of Palonosetron Versus Placebo for Preventing Postoperative Nausea and Vomiting

Candiotti, Keith A.; Kovac, Anthony L.; Melson, Timothy; Clerici, Giuseppina; Gan, Tong J.

doi:10.1213/ane.0b013e31817b5ebb

Cited by 133 publications

(116 citation statements)

References 17 publications

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“…In previous studies reported by Candiotti et al 45 and Kovac et al, 46 there was no statistical difference between palonosetron 0.075 mg and placebo in the reduction of PONV during the postoperative 24-72 hr. Compared with ondansetron, the combined results of four studies indicated that palonosetron can significantly reduce the incidence of PON (RR, 0.53; 95% CI, 0.33 to 0.86) but not POV within 24 to 48 or 72 hr after surgery.…”

Section: Early Povmentioning

confidence: 72%

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Efficacy of palonosetron for preventing postoperative nausea and vomiting: a systematic review and meta-analysis

Xiong

et al. 2015

Can J Anesth/J Can Anesth

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Purpose Palonosetron, a second-generation 5-hydroxytryptamine 3 receptor antagonist (5-HT 3 RA), has unique characteristics relative to first-generation 5-HT 3 RAs such as ondansetron. Nevertheless, it remains unclear if palonosetron is better than ondansetron for the prevention of nausea and vomiting during the first 24 hr after surgery and is thus the focus of this systematic review. RésuméObjectif Le palonosétron est un antagoniste du récepteur de la 5-hydroxytryptamine 3 (5-HT 3 RA) de deuxième génération; il présente des caractéristiques uniques par rapport aux 5-HT 3 RA de première génération tels que l'ondansétron. Néanmoins, il n'est pas certain que le palonosétron est meilleur que l'ondansétron pour la prévention des nausées et vomissements au cours des 24 premières heures suivant une chirurgie et cela est donc l'objet de cette revue systématique. Méthodes Nous avons effectué une recherche systématique dans les bases de données MEDLINE Ò ,

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Section: Early Povmentioning

confidence: 72%

“…43 In contrast, palonosetron thus far appears to be safe in terms of QT intervals. Results of a number of studies [44][45][46] revealed that palonosetron had no effect on the QT interval during surgery. Serotonin syndrome is another serious adverse event associated with the use of 5-HT 3 RAs.…”

Section: A Early Ponmentioning

confidence: 99%

Efficacy of palonosetron for preventing postoperative nausea and vomiting: a systematic review and meta-analysis

Xiong

et al. 2015

Can J Anesth/J Can Anesth

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“…patient is exposed to potential side effects from each drug that is administered. Palonosetron, at any dose, has not been found to prolong the QTc interval in contrast to the older 5-HT3 receptors [13]. If administering one drug is as effective as a multi-drug regimen, patient safety is increased without sacrificing efficacy.…”

Section: Discussionmentioning

confidence: 98%

“…Kovac et al [11] reported a complete response (CR) rate (no nausea and no vomting at any time interval) of 56% of patients who had received a dose of palonosetron 0.075mg. Candiotti [13] reports a CR rate of 43% at 0-24 h after surgery and 49% at 24-72h after surgery. This is consistent with the 60% success rate in the Pal group that we report in our study.…”

Section: Discussionmentioning

confidence: 99%

“…A complete response (CR) was defined as no vomiting and no rescue medication for any time interval. All patients completed an 18 question QOL-FLIE (Functional Living Index-Emesis) instrument at 96 hrs [13]. For statistical testing of the null hypothesis that the nausea responses of the two treatment groups were equal, we used an ordinal regression model (which included age, BMI; SPSS v 18).Data was also grouped as a binary (success/failure) and analyzed with chi square or Fisher's Exact test.…”

Section: Methodsmentioning

confidence: 99%

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A Randomized, Double Blind Study to Evaluate the Efficacy of Palonosetron with Dexamethasone Versus Palonosetron Alone for Prevention of Post-Operative Nausea and Vomiting in Subjects Undergoing Bariatric Surgeries with High Emetogenic Risk

Didehvar

Viola-Blitz²,

Haile³

et al. 2013

TOATJ

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Abstract:Introduction: Postoperative (PONV) and postdischarge (PDNV) nausea and vomiting are common (60-70%) after bariatric surgery. Palonosetron (Pal), a novel 5-HT3 antagonist, is an effective antiemetic with a prolonged duration of action in the setting of PDNV. We hypothesized that combination therapy with Palonosetron (Pal) and dexamethasone (Dex) would improve treatment in comparison to Palonosetron alone in patients at high risk for PONV. Methods:In this study, patients undergoing bariatric laparoscopic surgery under general anesthesia, a subgroup of a larger Phase IV clinical trial of patients who had laparoscopic surgery, were randomized to 8 mg Dex + 0.075mg Pal or saline + 0.075mg Pal. Data was collected postoperatively at 2, 6, 24 and 72 hrs. A Functional Living Index-Emesis (QOL-FLIE) test was administered at 96 hrs. Results:We enrolled 76 ASA 1-2 patients with at least 3 PONV risk factors. Both randomization groups had a low incidence of vomiting in the PACU (Pal, 0.0%; Pal + Dex, 5.4%) as well as at 72 hours (0.0% both groups). Complete response (no vomiting, no rescue medication) was not different between treatment groups at any time intervals. Cumulative success rates over the entire 72 hrs were 60.4% (Pal alone) vs. 60.0% (Pal + Dex). Nausea scores (4 point ordinal scale) were not different between groups for any time intervals. Cumulative success scores for nausea (score = "none"; 0-72 hrs) were 41.9% for the Pal group, and 55.2% for the Pal+ Dex group. The Pal + Dex group showed a trend toward greater satisfaction on the QOL-FLIE scores with the greatest differences in the "nausea domain". Discussion:The combination therapy (Pal + Dex) did not significantly reduce the incidence of PONV or PDNV when compared with Pal alone although a trend was observed indicating the possible increased efficacy of multi-drug therapy. There was no change in comparative efficacy over 72 hrs, possibly due to the low incidence of PDNV in both groups.

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Drugs for preventing postoperative nausea and vomiting in adults after general anaesthesia: a network meta-analysis

Weibel

Rücker

Eberhart

et al. 2020

Cochrane Database of Systematic Reviews

117

133

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A Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Three Different Doses of Palonosetron Versus Placebo for Preventing Postoperative Nausea and Vomiting

Abstract: A single 0.075-mg IV dose of palonosetron significantly increased the CR rate (no emetic episodes and no rescue medication) from 0 to 24 h, decreased nausea severity and patients experienced significantly less interference in their postoperative function due to PONV.

Cited by 133 publications

References 17 publications

Efficacy of palonosetron for preventing postoperative nausea and vomiting: a systematic review and meta-analysis

Efficacy of palonosetron for preventing postoperative nausea and vomiting: a systematic review and meta-analysis

A Randomized, Double Blind Study to Evaluate the Efficacy of Palonosetron with Dexamethasone Versus Palonosetron Alone for Prevention of Post-Operative Nausea and Vomiting in Subjects Undergoing Bariatric Surgeries with High Emetogenic Risk

Drugs for preventing postoperative nausea and vomiting in adults after general anaesthesia: a network meta-analysis

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