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Sevoflurane-Remifentanil Anaesthesia. The Risk of Post Operative Nausea

This study has been completed.
Sponsor:
Collaborator:
Nielsen, Jens OD, M.D.
Information provided by:
Viborg Hospital
ClinicalTrials.gov Identifier:
NCT00452855
First received: March 26, 2007
Last updated: March 28, 2007
Last verified: March 2007
History of Changes
  Purpose

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


Condition Intervention
Nausea
Vomiting
 Procedure: Sevoflurane-remifentanil anaesthesia

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Postoperative Nausea and Vomiting Are Similar When Propofol or Sevoflurane Are Used as Adjuvant to Remifentanil During Anaesthesia for Gynaecological Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Viborg Hospital:

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

Estimated Enrollment: 160
Study Start Date: January 2002
Study Completion Date: May 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00452855

Locations
Denmark
Viborg Hospital
Viborg, Denmark, 8800
Sponsors and Collaborators
Viborg Hospital
Nielsen, Jens OD, M.D.
Investigators
Principal Investigator: Jens Ole Dich JO Nielsen, MD
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00452855     History of Changes
Other Study ID Numbers: PropSevoRemi
Study First Received: March 26, 2007
Last Updated: March 28, 2007
Health Authority: Denmark: Ethics Committee

Keywords provided by Viborg Hospital:
Nausea
Vomiting
Post operative
Propofol remifentanil anaesthesia
Sevoflurane remifentanil anaesthesia

Additional relevant MeSH terms:
Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Anesthetics
Sevoflurane
Remifentanil
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Platelet Aggregation Inhibitors
Hematologic Agents
Anesthetics, Inhalation
Anesthetics, General
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Anesthetics, Intravenous

ClinicalTrials.gov processed this record on May 16, 2013