Skip to main content
Clinical Trials/NCT02021851
NCT02021851
Completed
Phase 4

THE EFFECT OF THE COMBINATION OF DEXAMETHASONE WITH ONDANSETRON VERSUS DEXAMETHASONE WITH APREPITANT TO PREVENT POSTOPERATIVE NAUSEA AND VOMITING IN PATIENTS UNDERGOING LAPAROSCOPIC SURGERY

Yeditepe University Hospital1 site in 1 country67 target enrollmentJuly 2011

Overview

Phase
Phase 4
Intervention
Dexamethasone and aprepitant
Conditions
Postoperative Nausea and Vomiting
Sponsor
Yeditepe University Hospital
Enrollment
67
Locations
1
Primary Endpoint
Complete response
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

Postoperative nausea and vomiting (PONV) is a common problem after general anesthesia. The incidence can be as high as 80 percent in high-risk patients. Investigators designed this randomized, double- blind, single-center study to compare the efficacy of the combination of dexamethasone with ondansetron and dexamethasone with aprepitant undergoing laparoscopic surgery.

Seventy American Society of Anesthesiologist (ASA) physical class I-II, age 18-60 years patients scheduled for laparoscopic surgery were included in this study. Anesthesia was induced with propofol, fentanyl, and rocuronium, and maintained with sevoflurane in oxygen / air mixture in all patients. Remifentanil was continuously infused during surgery. Patients were randomly divided into two groups. Patients in the dexamethasone and aprepitant group (group DA, n=35) received 40 mg aprepitant orally 1 to 2 hours before induction of anesthesia and 2 ml saline intravenous (iv) within the last 30 minutes of surgery. Patients in the dexamethasone and ondansetron group (group DO, n=35) received an oral placebo identical to aprepitant 1 to 2 hours before induction of anesthesia and 4 mg ondansetron iv within the last 30 minutes of surgery. All patient received iv 8 mg dexamethasone after induction of anesthesia.

PONV and postoperative opioid consumption were assessed for 24 hours postoperatively. The blindly evaluated primary outcome was complete response. The secondary outcomes were incidence of nausea, retching or vomiting, the need of rescue antiemetic and opioid consumption within 24 hours after surgery. Statistical analyses were performed using Mann-Whitney U test, Chi-square test, and Fisher's Exact test. P<0.05 was considered statistically significant.Investigators hypothesized that the antiemetic efficacy of the aprepitant and dexamethasone combination is superior compared with ondansetron and dexamethasone combination following the laparoscopic surgery.

Registry
clinicaltrials.gov
Start Date
July 2011
End Date
July 2012
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Yeditepe University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Sevgi Bilgen

Assistant professor

Yeditepe University Hospital

Eligibility Criteria

Inclusion Criteria

  • 18 Years to 60 Years
  • ASA (American Society of Anesthesiologist) physical status I or II
  • Patients undergoing laparoscopic gynecologic surgery or laparoscopic cholecystectomy

Exclusion Criteria

  • Hypersensitivity or contraindication to the study medications,
  • Antiemetic drug or steroid use within 24 hours before anesthesia,
  • History of diabetes mellitus,
  • History of motion sickness or postoperative nausea and vomiting,
  • Pregnancy,
  • Breast feeding

Arms & Interventions

Group DA: Dexamethasone and aprepitant

Group DA: Dexamethasone: 8 mg (intravenous), Aprepitant: 40 mg (oral)

Intervention: Dexamethasone and aprepitant

Group DO: Dexamethasone and ondansetron

Group DO: Dexamethasone: 8 mg (intravenous), Ondansetron: 4 mg (intravenous)

Intervention: Dexamethasone and ondansetron

Outcomes

Primary Outcomes

Complete response

Time Frame: One year

The primary outcome is complete response: A complete response is defined as no postoperative nausea (VRS≤3), retching or vomiting and no need for rescue antiemetic.

Secondary Outcomes

  • Need of rescue antiemetic(One year)
  • Nausea(One year)
  • Vomiting(One year)
  • Retching(One year)

Study Sites (1)

Loading locations...

Similar Trials