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Clinical Trials/NCT00712517
NCT00712517
Terminated
Not Applicable

Do Patients Anesthetized With Propofol Have Less Pain Than Those Anesthetized With Volatile?

The Cleveland Clinic1 site in 1 country90 target enrollmentSeptember 2010

Overview

Phase
Not Applicable
Intervention
propofol
Conditions
Varicose Vein
Sponsor
The Cleveland Clinic
Enrollment
90
Locations
1
Primary Endpoint
The primary outcome is morphine-equivalent use from the end of surgery until the first post-operative morning.
Status
Terminated
Last Updated
9 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
September 2010
End Date
May 2014
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Arms & Interventions

1

Patients will receive propofol anesthesia during varicose vein stripping surgery.

Intervention: propofol

2

Patients will receive sevoflurane anesthesia during varicose vein stripping surgery.

Intervention: sevoflurane

Outcomes

Primary Outcomes

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 Outcomes

  • To determine the average pain score for each group during the first four hours of recovery after surgery.(30 minute intervals for first 4 hours post operatively)

Study Sites (1)

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