Sevoflurane-Remifentanil Anaesthesia. The Risk of Post Operative Nausea - Tabular View

Tracking Information

First Received Date ^ICMJE

March 26, 2007

Last Updated Date

March 28, 2007

Start Date ^ICMJE

January 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00452855 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Sevoflurane-Remifentanil Anaesthesia. The Risk of Post Operative Nausea

Official Title ^ICMJE

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

Brief Summary

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

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 Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Nausea
Vomiting

Intervention ^ICMJE

Procedure: Sevoflurane-remifentanil anaesthesia

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

160

Completion Date

May 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT ID ^ICMJE

NCT00452855

Responsible Party

Study ID Numbers ^ICMJE

PropSevoRemi

Study Sponsor ^ICMJE

Viborg Hospital

Collaborators ^ICMJE

Nielsen, Jens OD, M.D.

Investigators ^ICMJE

Principal Investigator:

Jens Ole Dich JO Nielsen, MD

Unaffiliated

Information Provided By

Viborg Hospital

Verification Date

March 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP