Postoperative Nausea and Vomiting: Ramosetron Plus Aprepitant vs Palonosetron Plus Aprepitant

Overview

The purpose of this study was to compare the antiemetic efficacy of aprepitant plus palonosetron versus aprepitant plus ramosetron in high risk patients undergoing laparoscopic cholecystectomy.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 2015

Detailed Description

The purpose of this study was to compare the antiemetic efficacy of aprepitant plus palonosetron versus aprepitant plus ramosetron in high risk patients undergoing laparoscopic cholecystectomy. Study is performed during 24 hours after surgery.

Interventions

  • Drug: aprepitant
    • aprepitant 80 mg is given to all patients before surgery
  • Drug: palonosetron
    • palonosetron 0.075 mg is given to patients in the aprepitant plus palonosetron group after induction of general anesthesia
  • Drug: Ramosetron
    • ramosetron 0.3 mg is given to patients in the aprepitant plus ramosetron group after induction of general anesthesia

Arms, Groups and Cohorts

  • Experimental: aprepitant plus palonosetron
    • aprepitant 80 mg palonosetron 0.075 mg
  • Active Comparator: aprepitant plus ramosetron
    • aprepitant 80 mg ramosetron 0.3 mg

Clinical Trial Outcome Measures

Primary Measures

  • The Incidence of Postoperative Nausea and Vomiting
    • Time Frame: 24 hours
    • The incidence of postoperative nausea and vomiting during 24 hours postoperatively

Participating in This Clinical Trial

Inclusion Criteria

  • Non smoking, female patients, scheduled for laparoscopic cholecystectomy Exclusion Criteria:

  • Patients with gastrointestinal disorder, – Patients with allergies to any study medication, – Patients who had received any sedatives, opioid, steroid or antiemetics within 24 h before surgery

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Kyungpook National University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Younghoon Jeon, Professor – Kyungpook National University Hospital

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