Propofol Versus Volatile Anesthesia in Post Operative Pain Management

This study has suspended participant recruitment.
(Enrolling of participants has halted and the results are being gathered)
Information provided by (Responsible Party):
The Cleveland Clinic Identifier:
First received: July 7, 2008
Last updated: September 29, 2015
Last verified: September 2015
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 The Cleveland Clinic:

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: 90
Study Start Date: December 2010
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (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

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

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
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Please refer to this study by its identifier: NCT00712517

Olga Plattner , MD
Vienna, Austria
Sponsors and Collaborators
The Cleveland Clinic
Principal Investigator: Olga Plattner, MD Medical University of Vienna
  More Information

No publications provided

Responsible Party: The Cleveland Clinic Identifier: NCT00712517     History of Changes
Other Study ID Numbers: 42908
Study First Received: July 7, 2008
Last Updated: September 29, 2015
Health Authority: Austria: Ethikkommission

Keywords provided by The Cleveland Clinic:
postoperative pain
varicose vein

Additional relevant MeSH terms:
Pain, Postoperative
Varicose Veins
Cardiovascular Diseases
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Vascular Diseases
Anesthetics, General
Anesthetics, Inhalation
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Hematologic Agents
Hypnotics and Sedatives
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Therapeutic Uses processed this record on November 30, 2015