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Sevoflurane-Remifentanil Anaesthesia. The Risk of Post Operative Nausea

Primary Purpose

Nausea, Vomiting

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Sevoflurane-remifentanil anaesthesia
Sponsored by
Central Jutland Regional Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nausea focused on measuring Nausea, Vomiting, Post operative, Propofol remifentanil anaesthesia, Sevoflurane remifentanil anaesthesia

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Viborg Hospital

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 26, 2007
Last Updated
March 28, 2007
Sponsor
Central Jutland Regional Hospital
Collaborators
Nielsen, Jens OD, M.D.
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1. Study Identification

Unique Protocol Identification Number
NCT00452855
Brief Title
Sevoflurane-Remifentanil Anaesthesia. The Risk of Post Operative Nausea
Official Title
Postoperative Nausea and Vomiting Are Similar When Propofol or Sevoflurane Are Used as Adjuvant to Remifentanil During Anaesthesia for Gynaecological Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Central Jutland Regional Hospital
Collaborators
Nielsen, Jens OD, M.D.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea, Vomiting
Keywords
Nausea, Vomiting, Post operative, Propofol remifentanil anaesthesia, Sevoflurane remifentanil anaesthesia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
160 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Sevoflurane-remifentanil anaesthesia
Primary Outcome Measure Information:
Title
Nausea, incidence and intensity ( VAS score )in PACU and surgical ward
Title
Vomiting, incidence in PACU and surgical ward
Title
Total PONV after 24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Ole Dich JO Nielsen, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Viborg Hospital
City
Viborg
ZIP/Postal Code
8800
Country
Denmark

12. IPD Sharing Statement

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Sevoflurane-Remifentanil Anaesthesia. The Risk of Post Operative Nausea

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