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Propofol Versus Volatile Anesthesia in Post Operative Pain Management

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ClinicalTrials.gov Identifier: NCT00712517
Recruitment Status : Terminated (Enrolling of participants has halted and the results are being gathered)
First Posted : July 10, 2008
Last Update Posted : July 20, 2016
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic

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

Condition or disease Intervention/treatment Phase
Varicose Vein Postoperative Pain Drug: propofol Drug: sevoflurane Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Do Patients Anesthetized With Propofol Have Less Pain Than Those Anesthetized With Volatile?
Study Start Date : September 2010
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. The primary outcome is morphine-equivalent use from the end of surgery until the first post-operative morning. [ Time Frame: first post operative morning ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): NCT00712517


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00712517     History of Changes
Other Study ID Numbers: 42908
First Posted: July 10, 2008    Key Record Dates
Last Update Posted: July 20, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by The Cleveland Clinic:
postoperative pain
Piritramid
propofol
sevoflurane
varicose vein
Anesthesia

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