Propofol Versus Volatile Anesthesia in Post Operative Pain Management

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Outcomes Research Consortium.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Outcomes Research Consortium
ClinicalTrials.gov Identifier:
NCT00712517
First received: July 7, 2008
Last updated: February 16, 2011
Last verified: February 2011
  Purpose

The study will test the hypothesis that patients anesthetized with propofol suffer less postoperative pain than those anesthetized with sevoflurane.


Condition Intervention
Varicose Vein
Postoperative Pain
Drug: propofol
Drug: sevoflurane

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Do Patients Anesthetized With Propofol Have Less Pain Than Those Anesthetized With Volatile?

Resource links provided by NLM:


Further study details as provided by Outcomes Research Consortium:

Primary Outcome Measures:
  • The primary outcome is Piritramid use from the end of surgery until the first post-operative morning. [ Time Frame: first post operative morning ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the average pain score for each group during the first four hours of recovery after surgery. [ Time Frame: 30 minute intervals for first 4 hours post operatively ] [ Designated as safety issue: No ]

Estimated Enrollment: 68
Study Start Date: December 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Patients will receive propofol anesthesia during varicose vein stripping surgery.
Drug: propofol
propofol anesthesia 3-5mg/kg
Other Name: Diprivan
Active Comparator: 2
Patients will receive sevoflurane anesthesia during varicose vein stripping surgery.
Drug: sevoflurane
sevoflurane anesthesia

Detailed Description:

Patients undergoing s stripping operation for varicose veins will be randomized to one of two groups. Group 1 patients will receive propofol anesthesia. Group 2 patients will receive sevoflurane anesthesia. Intraoperative measurements including mean-arterial pressure, heart rate, propofol infusion rate, remifentanil infusion rate, and end-tidal sevoflurane concentration will be taken at 15 minute intervals. Patients in both groups will receive Piritramid as necessary to control pain either intravenously or through patient controlled pump. VAS pain score, mean-arterial pressure, heart rate, nausea will be evaluated at 30 minute intervals during the first four postoperative hours. Piritramid dosage and vomiting will be recorded through the first postoperative morning. Patients will rate pain based on the VAS score for the period between leaving the recovery room and the first postoperative morning

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants will undergo a stripping operation for varicose veins
  • Surgery will be performed by one physician only
  • Written informed consent

Exclusion Criteria:

  • Any contraindications to the proposed interventions
  • Procedures done under regional anesthesia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00712517

Contacts
Contact: Olga Plattner, MD olga.plattner@meduniwien.ac.at

Locations
Austria
Olga Plattner , MD Recruiting
Vienna, Austria
Contact: Olga Plattner, M.D.       olga.plattner@meduniwien.ac.at   
Principal Investigator: Olga Plattner, M.D.         
Sponsors and Collaborators
Outcomes Research Consortium
Investigators
Principal Investigator: Olga Plattner, MD Medical University of Vienna
  More Information

No publications provided

Responsible Party: Olga M. Plattner,M.D., Vienna General Hospital/University of Vienna
ClinicalTrials.gov Identifier: NCT00712517     History of Changes
Other Study ID Numbers: 42908
Study First Received: July 7, 2008
Last Updated: February 16, 2011
Health Authority: Austria: Ethikkommission

Keywords provided by Outcomes Research Consortium:
postoperative pain
Piritramid
propofol
sevoflurane
varicose vein
Anesthesia

Additional relevant MeSH terms:
Pain, Postoperative
Varicose Veins
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Vascular Diseases
Cardiovascular Diseases
Anesthetics
Propofol
Sevoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Hypnotics and Sedatives
Platelet Aggregation Inhibitors
Hematologic Agents
Anesthetics, Inhalation

ClinicalTrials.gov processed this record on April 16, 2014