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Effect of the Dexamethasone-Ondansetron Combination Versus Dexamethasone-Aprepitant Combination to Prevent Postoperative Nausea and Vomiting.

ABSTRACT: Objective:Postoperative nausea and vomiting (PONV) is a common problem associated with general anaesthesia. The incidence can be as high as 80% in high-risk patients. Our primary objective was to compare the efficacy of the combination of dexamethasone-ondansetron and dexamethasone-aprepitant in patients undergoing laparoscopic surgery. Methods:Seventy 18 to 60 years old patients scheduled for laparoscopic surgery were included in the study. Sixty-seven patients completed the study. Patients in the dexamethasone-aprepitant group (group DA, n=35) received 40 mg of aprepitant orally 1-2 hours before the induction of anaesthesia and 2 mL saline intravenously (iv) within the last 30 minutes of surgery; patients in the dexamethasone-ondansetron group (group DO, n=35) received oral placebo identical to aprepitant 1-2 hours before the induction of anaesthesia and 4 mg ondansetron iv within the last 30 minutes of surgery. All patients received 8 mg dexamethasone iv after the induction of anaesthesia. The primary outcome was a complete response (no postoperative nausea, retching and vomiting and no need for rescue antiemetic); the secondary outcomes were the incidence of nausea, retching, vomiting, the need of rescue antiemetic and opioid consumption within 24 hours after surgery. Results:A complete response was not significantly different between the groups (group DO: 67%, DA: 69%) at 24 hours (p=0.93). The incidence of PONV and postoperative opioid consumption was similar between the groups. Conclusion:The study was designed to evaluate whether the combination of dexamethasone-aprepitant is better than the combination of dexamethasone-ondansetron regarding the complete response for PONV in patients undergoing laparoscopic surgery. The results however showed that dexamethasone-aprepitant has not improved the complete response for PONV compared to dexamethasone-ondansetron.

SUBMITTER: Bilgen S

PROVIDER: S-EPMC6157978 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature

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Effect of the Dexamethasone-Ondansetron Combination Versus Dexamethasone-Aprepitant Combination to Prevent Postoperative Nausea and Vomiting.

Bilgen Sevgi S Kızılcık Nurcan N Haliloğlu Murat M Yıldırım Gazi G Kaspar Elif Çiğdem EÇ Köner Özge Ö

Turkish journal of anaesthesiology and reanimation 20180904 5

<h4>Objective</h4>Postoperative nausea and vomiting (PONV) is a common problem associated with general anaesthesia. The incidence can be as high as 80% in high-risk patients. Our primary objective was to compare the efficacy of the combination of dexamethasone-ondansetron and dexamethasone-aprepitant in patients undergoing laparoscopic surgery.<h4>Methods</h4>Seventy 18 to 60 years old patients scheduled for laparoscopic surgery were included in the study. Sixty-seven patients completed the stud ...[more]

PMID: 30263861

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Project description:Postoperative nausea and vomiting (PONV) is one of the most common adverse outcomes after strabismus surgery. The primary outcome of this prospective, randomized, double-blind study was to compare the incidences of nausea or vomiting, and patient satisfaction of ondansetron and ramosetron after strabismus surgery under general anesthesia. The secondary outcome was to investigate whether the number of involved extraocular muscles (EOMs) in strabismus surgery was related to PONV.One hundred and five patients (aged 18-60 years) undergoing strabismus surgery were allocated randomly to one of the three groups: placebo, ondansetron, or ramosetron. Patients received 2 ml placebo, 4 mg ondansetron, or 0.3 mg ramosetron at the end of surgery. Each of the three groups was subdivided into two subgroups according to the number of EOMs involved in the surgery: subgroup S, single-muscle correction; subgroup M, multiple-muscle correction. The incidences of nausea or vomiting, and patient satisfaction at 2, 24 and 48 h after surgery were analyzed as primary outcome. With regard to subgroups S and M in the placebo, ondansetron and ramosetron groups, incidences of nausea or vomiting, and patient satisfaction at 2, 24 and 48 h after surgery were analyzed as seconadary outcome.The incidence of nausea was significantly lower in the ramosetron group at 2 h (9.4 %) than in the placebo (45.2 %) and ondansetron (34.7 %) groups (P < 0.05). The incidence of nausea was also significantly lower in the ramosetron group at 24 h than in the other groups (P < 0.05). Patients in the ramosetron group were more satisfied at 2 h (8.11 ± 0.98) and 24 h (8.50 ± 0.67) after surgery than those in the other groups (P < 0.05). With regard to subgroups S and M in the placebo, ondansetron and ramosetron groups, there were no significant differences in either the incidence of nausea or patient satisfaction.Ramosetron has superior antiemetic activity to ondansetron in adult strabismus surgery patients. The number of EOMs involved in strabismus surgery was not related to the incidence of PONV.Clinical Research Information Service (CRiS) Identifier: KCT0000688 . Date of registration: 27 February 2013.

Project description:This study compared palonosetron and ondansetron as rescue medications for postoperative nausea and vomiting (PONV) in patients who received prophylactic ondansetron. Although guidelines recommend use of an agent from a different class when prophylaxis has failed, palonosetron has unique properties relative to other serotonin 5-HT3 receptor antagonists. Prior trials assessing its use for rescue have had conflicting results. Although palonosetron has compared favorably with ondansetron for PONV prevention, the drugs have not been compared in the rescue setting of failure of 5-HT3 receptor antagonist prophylaxis.This was a randomized, open-label, multicenter trial comparing the efficacy and safety of intravenous palonosetron 0.075 mg and intravenous ondansetron 4 mg in patients experiencing PONV following laparoscopic abdominal or gynecological surgery despite prophylactic ondansetron.Of 239 patients screened, 220 were enrolled and 98 were treated for PONV: 48 and 50 in the palonosetron and ondansetron arms, respectively. Complete control during 72 hours after study drug administration was achieved in 25.0% of palonosetron recipients and 18.0% of ondansetron recipients (95% confidence interval [CI], -9.2, 23.3; p?=?0.40). Corresponding incidences of vomiting were 29.2% for palonosetron and 48.0% for ondansetron (95% CI, -0.06, 37.7; p?=?0.057), and 62.5% and 56.0% required additional rescue treatment, respectively (95% CI, -25.9, 12.9; p?=?0.52). Other than a similar incidence of procedural pain in the 2 groups, the most common treatment-emergent adverse events, which were generally mild, were headache (14.6% vs 12.0%), constipation (8.3% vs 10.0%), and dizziness (6.3% vs 8.0%), for the palonosetron and ondansetron groups, respectively.Palonosetron and ondansetron did not show differences in the primary efficacy endpoint of CC during the 72 hours after study drug administration. There was a trend toward less emesis in the 0-72 h time period favoring palonosetron. While larger studies are needed to fully assess any clinical benefits of palonosetron to rescue patients who have failed ondansetron prophylaxis for PONV, the benefit, if any, would be limited based on this study.ClinicalTrials.gov, NCT00967499 (Registered August 27, 2009).

Project description:INTRODUCTION:Postoperative nausea and vomiting (PONV) is among the most common distressing complications of surgery under anesthesia. Previous studies have demonstrated that patients who undergo craniotomy have incidences of nausea and vomiting as high as 50-70%. The main purpose of this pilot study is to assess the incidence of PONV by using two different prophylactic regimens in subjects undergoing a craniotomy. Thus, we designed this study to assess the efficacy and safety of triple therapy with the combination of dexamethasone, promethazine, and aprepitant versus ondansetron to reduce the incidence of PONV in patients undergoing craniotomy. MATERIALS AND METHODS:This is a prospective, single center, two-armed, randomized, double-dummy, double-blind, pilot study. Subjects were randomly assigned to one of the two treatment groups. Subjects received 40?mg of aprepitant pill (or matching placebo pill) 30-60?min before induction of anesthesia and 4?mg of ondansetron IV (or 2?ml of placebo saline solution) at induction of anesthesia. In addition, all subjects received 25?mg of promethazine IV and 10?mg of dexamethasone IV at induction of anesthesia. Assessments of PONV commenced for the first 24?h after surgery and were subsequently assessed for up to 5?days. RESULTS:The overall incidence of PONV during the first 24?h after surgery was 31.0% (n?=?15) in the aprepitant group and 36.2% (n?=?17) for the ondansetron group. The median times to first emetic and significant nausea episodes were 7.6 (2.9, 48.7) and 14.3 (4.4, 30.7) hours, respectively, for the aprepitant group and 6.0 (2.2, 29.5) and 9.6?(0.7, 35.2) hours, respectively, for the ondansetron group. There were no statistically significant differences between these groups. No adverse events directly related to study medications were found. CONCLUSION:This pilot study showed similar effectiveness when comparing the two PONV prophylaxis regimens. Our data showed that both treatments could be effective regimens to prevent PONV in patients undergoing craniotomy under general anesthesia. Future trials testing new PONV prophylaxis regimens in this surgical population should be performed to gain a better understanding of how to best provide prophylactic treatment.

Project description:Objectives To determine whether preoperative dexamethasone reduces postoperative vomiting in patients undergoing elective bowel surgery and whether it is associated with other measurable benefits during recovery from surgery, including quicker return to oral diet and reduced length of stay.Design Pragmatic two arm parallel group randomised trial with blinded postoperative care and outcome assessment.Setting 45 UK hospitals.Participants 1350 patients aged 18 or over undergoing elective open or laparoscopic bowel surgery for malignant or benign pathology.Interventions Addition of a single dose of 8 mg intravenous dexamethasone at induction of anaesthesia compared with standard care.Main outcome measures Primary outcome: reported vomiting within 24 hours reported by patient or clinician.Secondary outcomesvomiting with 72 and 120 hours reported by patient or clinician; use of antiemetics and postoperative nausea and vomiting at 24, 72, and 120 hours rated by patient; fatigue and quality of life at 120 hours or discharge and at 30 days; time to return to fluid and food intake; length of hospital stay; adverse events.Results 1350 participants were recruited and randomly allocated to additional dexamethasone (n=674) or standard care (n=676) at induction of anaesthesia. Vomiting within 24 hours of surgery occurred in 172 (25.5%) participants in the dexamethasone arm and 223 (33.0%) allocated standard care (number needed to treat (NNT) 13, 95% confidence interval 5 to 22; P=0.003). Additional postoperative antiemetics were given (on demand) to 265 (39.3%) participants allocated dexamethasone and 351 (51.9%) allocated standard care (NNT 8, 5 to 11; P<0.001). Reduction in on demand antiemetics remained up to 72 hours. There was no increase in complications.Conclusions Addition of a single dose of 8 mg intravenous dexamethasone at induction of anaesthesia significantly reduces both the incidence of postoperative nausea and vomiting at 24 hours and the need for rescue antiemetics for up to 72 hours in patients undergoing large and small bowel surgery, with no increase in adverse events.Trial registration EudraCT (2010-022894-32) and ISRCTN (ISRCTN21973627).

Dataset Information

Effect of the Dexamethasone-Ondansetron Combination Versus Dexamethasone-Aprepitant Combination to Prevent Postoperative Nausea and Vomiting.

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Effect of the Dexamethasone-Ondansetron Combination Versus Dexamethasone-Aprepitant Combination to Prevent Postoperative Nausea and Vomiting.

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