Propofol Versus Volatile Anesthesia in Post Operative Pain Management - Full Text View

Sponsored by:	Outcomes Research Consortium
Information provided by:	Outcomes Research Consortium
ClinicalTrials.gov Identifier:	NCT00712517

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

MedlinePlus related topics: Anesthesia Varicose Veins

Drug Information available for: Propofol Sevoflurane

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Do Patients Anesthetized With Propofol Have Less Pain Than Those Anesthetized With Volatile?

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:	July 2008
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Patients will receive propofol anesthesia during varicose vein stripping surgery.	Drug: propofol propofol anesthesia 3-5mg/kg
2: Active Comparator 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

OlgaPlattner@compuserve.com

Sponsors and Collaborators

Outcomes Research Consortium

Investigators

Principal Investigator:

Olga Plattner, MD

Medical University of Vienna

More Information

Responsible Party:	Vienna General Hospital/University of Vienna ( Olga M. Plattner,M.D. )
Study ID Numbers:	42908
Study First Received:	July 7, 2008
Last Updated:	July 9, 2008
ClinicalTrials.gov Identifier:	NCT00712517
Health Authority:	Austria: Ethikkommission

Keywords provided by Outcomes Research Consortium:

postoperative pain
Piritramid
propofol

sevoflurane
varicose vein
Anesthesia

Study placed in the following topic categories:

Signs and Symptoms
Postoperative Complications
Varicose Veins
Pirinitramide
Vascular Diseases

Pain
Propofol
Pain, Postoperative
Sevoflurane

Additional relevant MeSH terms:

Anesthetics, Intravenous
Physiological Effects of Drugs
Hematologic Agents
Anesthetics
Central Nervous System Depressants
Pharmacologic Actions
Anesthetics, Inhalation

Pathologic Processes
Anesthetics, General
Therapeutic Uses
Hypnotics and Sedatives
Cardiovascular Diseases
Platelet Aggregation Inhibitors
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009