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NCT00452855 Clinical Trial

Sevoflurane-Remifentanil Anaesthesia. The Risk of Post Operative Nausea

Nausea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00452855
Other study ID # PropSevoRemi
Secondary ID
Status Completed
Phase N/A
First received March 26, 2007
Last updated March 28, 2007
Start date January 2002
Est. completion date May 2005

Study information
Verified date March 2007
Source Central Jutland Regional Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: Ethics Committee
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 160
Est. completion date May 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Procedure:
• Sevoflurane-remifentanil anaesthesia

Locations
Country Name City State
Denmark Viborg Hospital Viborg

Sponsors (2)
Lead Sponsor Collaborator
Central Jutland Regional Hospital Nielsen, Jens OD, M.D.

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Nausea, incidence and intensity ( VAS score )in PACU and surgical ward
Primary Vomiting, incidence in PACU and surgical ward
Primary Total PONV after 24 hours
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