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A Prospective, Randomized, Double-Blinded, Double-Dummy Pilot Study to Assess the Preemptive Effect of Triple Therapy with Aprepitant, Dexamethasone, and Promethazine versus Ondansetron, Dexamethasone and Promethazine on Reducing the Incidence of Postoperative Nausea and Vomiting Experienced by Patients Undergoing Craniotomy Under General Anesthesia.

ABSTRACT: 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.

SUBMITTER: Bergese SD

PROVIDER: S-EPMC4932110 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

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A Prospective, Randomized, Double-Blinded, Double-Dummy Pilot Study to Assess the Preemptive Effect of Triple Therapy with Aprepitant, Dexamethasone, and Promethazine versus Ondansetron, Dexamethasone and Promethazine on Reducing the Incidence of Postoperative Nausea and Vomiting Experienced by Patients Undergoing Craniotomy Under General Anesthesia.

Bergese Sergio Daniel SD Puente Erika G EG Antor Maria A MA Viloria Adolfo L AL Yildiz Vedat V Kumar Nicolas Alexander NA Kumar Nicolas Alexander NA Uribe Alberto A AA

Frontiers in medicine 20160705

<h4>Introduction</h4>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 t ...[more]

PMID: 27458584

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Project description:BackgroundCoadministration of different antiemetics proved to decrease postoperative nausea and vomiting (PONV) after laparoscopic sleeve gastrectomy (LSG). This trial compared aprepitant/dexamethasone (A/D) combination vs mirtazapine/dexamethasone (M/D) combination vs dexamethasone (D) alone for prevention of PONV in morbidly obese patients undergoing LSG.MethodsNinety patients scheduled for LSG were randomly allocated to receive 8 mg dexamethasone intravenous infusion (IVI) only in the D group or in addition to 80 mg aprepitant capsule in the A/D group or in addition to 30 mg mirtazapine tablet in the M/D group. Assessment of PONV was carried out at 0-2 h (early) and 2-24 h (late). The primary outcome was the complete response 0-24 h after surgery. Collective PONV, postoperative pain, side effects and patient satisfaction score were considered as secondary outcomes.ResultsThe A/D and M/D groups were superior to the D group for a complete response within 0-24 h after surgery (79.3% for the A/D group, 78.6% for the M/D group, and 20.7% for the D group). The D group was inferior to the A/D and M/D groups regarding collective PONV and use of rescue antiemetic 0-24 h after surgery (P < 0.001, P < 0.001, respectively). The peak nausea scores (2-24 h) were significantly reduced in the M/D group in comparison to the D group (P=0.005). Patients in the M/D group showed high sedation scores, while those in the A/D group showed low pain scores (2-24 h) and less analgesic requirements (P < 0.001, P < 0.001, P < 0.001, respectively). The A/D and M/D groups were superior to the D group with regard to the patient satisfaction score (P < 0.001).ConclusionAprepitant/dexamethasone combination and mirtazapine/dexamethasone combination were superior to dexamethasone alone in alleviating postoperative nausea and vomiting in morbidly obese patients scheduled to undergo laparoscopic sleeve gastrectomy. Trial Registration: ClinicalTrials.gov identifier: NCT04013386.

Project description:INTRODUCTION:Postoperative nausea and vomiting (PONV) is a displeasing experience that distresses surgical patients during the first 24?h after a surgical procedure. The incidence of postoperative nausea occurs in about 50%, the incidence of postoperative vomiting is about 30%, and in high-risk patients, the PONV rate could be as high as 80%. Therefore, the study design of this single arm, non-randomized, pilot study assessed the efficacy and safety profile of a triple therapy combination with palonosetron, dexamethasone, and promethazine to prevent PONV in patients undergoing craniotomies under general anesthesia. METHODS:The research protocol was approved by the institutional review board and 40 subjects were provided written informed consent. At induction of anesthesia, a triple therapy of palonosetron 0.075?mg IV, dexamethasone 10?mg IV, and promethazine 25?mg IV was given as PONV prophylaxis. After surgery, subjects were transferred to the surgical intensive care unit or post anesthesia care unit as clinically indicated. Ondansetron 4?mg IV was administered as primary rescue medication to subjects with PONV symptoms. PONV was assessed and collected every 24?h for 5?days via direct interview and/or medical charts review. RESULTS:The overall incidence of PONV during the first 24?h after surgery was 30% (n?=?12). The incidence of nausea and emesis 24?h after surgery was 30% (n?=?12) and 7.5% (n?=?3), respectively. The mean time to first emetic episode, first rescue, and first significant nausea was 31.3 (±33.6), 15.1 (±25.8), and 21.1 (±25.4) hours, respectively. The overall incidence of nausea and vomiting after 24-120?h period after surgery was 30% (n?=?12). The percentage of subjects without emesis episodes over 24-120?h postoperatively was 70% (n?=?28). No subjects presented a prolonged QTc interval ?500?ms before and/or after surgery. CONCLUSION:Our data demonstrated that this triple therapy regimen may be an adequate alternative regimen for the treatment of PONV in patients undergoing neurological surgery under general anesthesia. More studies with a control group should be performed to demonstrate the efficacy of this regimen and that palonosetron is a low risk for QTc prolongation. CLINICALTRIALSGOV IDENTIFIER:NCT02635828 (https://clinicaltrials.gov/show/NCT02635828).

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.

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