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Sevoflurane-Remifentanil Anaesthesia. The Risk of Post Operative Nausea

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ClinicalTrials.gov Identifier: NCT00452855
Recruitment Status : Completed
First Posted : March 28, 2007
Last Update Posted : March 29, 2007
Nielsen, Jens OD, M.D.
Information provided by:
Central Jutland Regional Hospital

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.

Condition or disease Intervention/treatment
Nausea Vomiting Procedure: Sevoflurane-remifentanil anaesthesia

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  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : January 2002
Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Nausea, incidence and intensity ( VAS score )in PACU and surgical ward
  2. Vomiting, incidence in PACU and surgical ward
  3. Total PONV after 24 hours

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00452855

Viborg Hospital
Viborg, Denmark, 8800
Sponsors and Collaborators
Central Jutland Regional Hospital
Nielsen, Jens OD, M.D.
Principal Investigator: Jens Ole Dich JO Nielsen, MD

ClinicalTrials.gov Identifier: NCT00452855     History of Changes
Other Study ID Numbers: PropSevoRemi
First Posted: March 28, 2007    Key Record Dates
Last Update Posted: March 29, 2007
Last Verified: March 2007

Keywords provided by Central Jutland Regional Hospital:
Post operative
Propofol remifentanil anaesthesia
Sevoflurane remifentanil anaesthesia

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