Propofol Versus Volatile Anesthesia in Post Operative Pain Management

NCT ID: NCT00712517

Last Updated: 2016-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2014-05-31

Brief Summary

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

Detailed Description

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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

Conditions

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Varicose Vein Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Patients will receive propofol anesthesia during varicose vein stripping surgery.

Group Type ACTIVE_COMPARATOR

propofol

Intervention Type DRUG

propofol anesthesia 3-5mg/kg

2

Patients will receive sevoflurane anesthesia during varicose vein stripping surgery.

Group Type ACTIVE_COMPARATOR

sevoflurane

Intervention Type DRUG

sevoflurane anesthesia

Interventions

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propofol

propofol anesthesia 3-5mg/kg

Intervention Type DRUG

sevoflurane

sevoflurane anesthesia

Intervention Type DRUG

Other Intervention Names

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Diprivan

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Olga Plattner, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

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Olga Plattner , MD

Vienna, , Austria

Site Status

Countries

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Austria

References

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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.

Reference Type DERIVED
PMID: 27638296 (View on PubMed)

Other Identifiers

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42908

Identifier Type: -

Identifier Source: org_study_id

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