Prevention Post Operative Nausea Vomiting in Ambulatory Gynecologic Laparoscopy

July 29, 2012 updated by: Thanyamon Asampinwat, Prince of Songkla University
The purpose of this study is to compare the incidence of Postoperative nausea and vomiting between the intervention group who received multimodal antiemetic management and the control group who did not get this protocol.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

340

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Songkhla
      • Hat Yai, Songkhla, Thailand, 90110
        • Anesthesiology Department, Faculty of Medicine, Prince of Songkla University

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 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Ambulatory gynecologic laparoscopy
  • Age 18-45 years
  • ASA class 1-2

Exclusion Criteria:

  • The patients who take opioid, steroid, pyschotics or antiemetic drug within 24 hours before surgery
  • History of antiemetic, anesthetic and analgesic drugs allergy
  • Pregnancy or breast feeding
  • Body mass index >34 kg/square metre

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Multimodal antiemetic management group
Multimodal antiemetic group : Low risk :no PONV prophylaxis moderate risk : ondansetron 4 mg iv high risk : dexamethasone 4 mg + ondansetron 4 mg Extremely high risk : dexamethasone 4 mg + ondansetron 4 mg + dimenhydrinate 1 mg
Drug: Dexamethasone
4 mg iv before induction for high and extremely high risk
Other Names:
  • Multimodal antiemetic group :
  • high risk : dexamethasone 4 mg + ondansetron 4 mg
  • Extremely high risk : dexamethasone 4 mg +
  • ondansetron 4 mg +
  • dimenhydrinate 1 mg
Drug: Ondansetron
4 mg iv before ended surgery 30 min
Drug: Dimenhydrinate
1 mg/kg iv before ended surgery 30 min
Active Comparator: Control group
Control group: Low and moderate risk : no PONV prophylaxis High risk : Ondansetron 4 mg. iv Extremely high risk : Ondansetron 4 mg .iv
Drug: Ondansetron
4 mg iv before ended surgery 30 min

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of PONV in ambulatory gynecologic laparoscopy
Time Frame: four year
four year

Collaborators and Investigators

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

Sponsor

Prince of Songkla University

Investigators

  • Principal Investigator: Thanyamon Asampinwat, MD, Anesthesiology department, Faculty of Medicine, Prince of Songkla University Thailand

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

March 1, 2008

Primary Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

February 28, 2012

First Submitted That Met QC Criteria

March 2, 2012

First Posted (Estimate)

March 5, 2012

Study Record Updates

Last Update Posted (Estimate)

July 31, 2012

Last Update Submitted That Met QC Criteria

July 29, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PONV9268

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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