Propofol Versus Volatile Anesthesia in Post Operative Pain Management
Recruitment status was Recruiting
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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? |
- 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 ]
- 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 |
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| Contact: Olga Plattner, MD | olga.plattner@meduniwien.ac.at |
| Austria | |
| Olga Plattner , MD | Recruiting |
| Vienna, Austria | |
| Contact: Olga Plattner, M.D. olga.plattner@meduniwien.ac.at | |
| Principal Investigator: Olga Plattner, M.D. | |
| 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 May 16, 2013