Back to resultsPropofol Versus Volatile Anesthesia in Post Operative Pain Management
Primary Purpose
Varicose Vein, Postoperative Pain
Status
Terminated
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
propofol
sevoflurane
Sponsored by
About this trial
This is an interventional prevention trial for Varicose Vein focused on measuring postoperative pain, Piritramid, propofol, sevoflurane, varicose vein, Anesthesia
Eligibility 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
Sites / Locations
- Olga Plattner , MD
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Patients will receive propofol anesthesia during varicose vein stripping surgery.
Patients will receive sevoflurane anesthesia during varicose vein stripping surgery.
Outcomes
Primary Outcome Measures
The primary outcome is morphine-equivalent use from the end of surgery until the first post-operative morning.
Secondary Outcome Measures
To determine the average pain score for each group during the first four hours of recovery after surgery.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00712517
Brief Title
Propofol Versus Volatile Anesthesia in Post Operative Pain Management
Official Title
Do Patients Anesthetized With Propofol Have Less Pain Than Those Anesthetized With Volatile?
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Terminated
Why Stopped
Enrolling of participants has halted and the results are being gathered
Study Start Date
September 2010 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study will test the hypothesis that patients anesthetized with propofol suffer less postoperative pain than those anesthetized with sevoflurane.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicose Vein, Postoperative Pain
Keywords
postoperative pain, Piritramid, propofol, sevoflurane, varicose vein, Anesthesia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Patients will receive propofol anesthesia during varicose vein stripping surgery.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Patients will receive sevoflurane anesthesia during varicose vein stripping surgery.
Intervention Type
Drug
Intervention Name(s)
propofol
Other Intervention Name(s)
Diprivan
Intervention Description
propofol anesthesia 3-5mg/kg
Intervention Type
Drug
Intervention Name(s)
sevoflurane
Intervention Description
sevoflurane anesthesia
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olga Plattner, MD
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Olga Plattner , MD
City
Vienna
Country
Austria
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27638296
Citation
Windpassinger M, Plattner O, Gemeiner J, Bohler K, Luntzer R, Klimscha W, Yang D, Mascha EJ, Sessler DI. Opioid use after propofol or sevoflurane anesthesia: a randomized trial. Can J Anaesth. 2016 Nov;63(11):1258-65. doi: 10.1007/s12630-016-0728-5. Epub 2016 Sep 14.
Results Reference
derived
Learn more about this trial
Propofol Versus Volatile Anesthesia in Post Operative Pain Management
We'll reach out to this number within 24 hrs