Sevoflurane-Remifentanil Anaesthesia. The Risk of Post Operative Nausea

March 28, 2007 updated by: Central Jutland Regional Hospital

Postoperative Nausea and Vomiting Are Similar When Propofol or Sevoflurane Are Used as Adjuvant to Remifentanil During Anaesthesia for Gynaecological Surgery

The purpose of this study is to determine whether sevoflurane-remifentanil anaesthesia is similar to propofol-remifentanil anaesthesia concerning post- operative nausea and vomiting.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Propofol and sevoflurane anaesthesia are used world wide at the anaesthetists discretion.

Propofol is superior to inhalational anaesthetics as anaesthesia for patients at risk of post operative nausea and vomiting (PONV) as PONV is diminished. However, when remifentanil is used as adjuvant to sevoflurane, the total dose of the latter is reduced.

Therefore, we wanted to investigate if sevoflurane-remifentanil anaesthesia is similar to propofol-remifentanil anaesthesia with emphasis on nausea, vomiting and total PONV during 24 hours.

In the post anaesthesia care unit (PACU) and in the surgical ward nausea was scored on a visual analogue score. Vomiting was registered.

Study Type

Interventional

Enrollment

160

Phase

  • Not Applicable

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

  • Denmark
      • Viborg, Denmark, 8800
        • Viborg Hospital

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 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Females younger than 50 years
  • ASA I-II
  • Scheduled to gynaecological laparotomies or laparoscopies

Exclusion Criteria:

  • Medication known to act anti-emetic
  • ASA status greater than II
  • Malignant hyperthermia
  • Allergy to the drugs used.

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: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Nausea, incidence and intensity ( VAS score )in PACU and surgical ward
Vomiting, incidence in PACU and surgical ward
Total PONV after 24 hours

Collaborators and Investigators

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

Sponsor

Central Jutland Regional Hospital

Collaborators

Nielsen, Jens OD, M.D.

Investigators

  • Principal Investigator: Jens Ole Dich JO Nielsen, MD

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

January 1, 2002

Study Completion (ACTUAL)

May 1, 2005

Study Registration Dates

First Submitted

March 26, 2007

First Submitted That Met QC Criteria

March 27, 2007

First Posted (ESTIMATE)

March 28, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

March 29, 2007

Last Update Submitted That Met QC Criteria

March 28, 2007

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PropSevoRemi

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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