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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00712517
Other study ID # 42908
Secondary ID
Status Terminated
Phase N/A
First received July 7, 2008
Last updated July 18, 2016
Start date September 2010
Est. completion date May 2014

Study information

Verified date July 2016
Source The Cleveland Clinic
Contact n/a
Is FDA regulated No
Health authority Austria: Ethikkommission
Study type Interventional

Clinical Trial Summary

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


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


Recruitment information / eligibility

Status Terminated
Enrollment 90
Est. completion date May 2014
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

Drug:
propofol
propofol anesthesia 3-5mg/kg
sevoflurane
sevoflurane anesthesia

Locations

Country Name City State
Austria Olga Plattner , MD Vienna

Sponsors (1)

Lead Sponsor Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary The primary outcome is morphine-equivalent use from the end of surgery until the first post-operative morning. first post operative morning No
Secondary 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 No
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