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

April 20, 2017 updated by: Younghoon Jeon, Kyungpook National University Hospital
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: aprepitant plus palonosetron
aprepitant 80 mg palonosetron 0.075 mg
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
Active Comparator: aprepitant plus ramosetron
aprepitant 80 mg ramosetron 0.3 mg
Drug: aprepitant
aprepitant 80 mg is given to all patients before surgery
Drug: Ramosetron
ramosetron 0.3 mg is given to patients in the aprepitant plus ramosetron group after induction of general anesthesia

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyungpook National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

October 31, 2015

First Submitted That Met QC Criteria

November 4, 2015

First Posted (Estimate)

November 5, 2015

Study Record Updates

Last Update Posted (Actual)

April 25, 2017

Last Update Submitted That Met QC Criteria

April 20, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KNUH 2014-05-016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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