NCT00712517

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 10, 2008

Completed
2.1 years until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

July 20, 2016

Status Verified

July 1, 2016

Enrollment Period

3.7 years

First QC Date

July 7, 2008

Last Update Submit

July 18, 2016

Conditions

Keywords

postoperative painPiritramidpropofolsevofluranevaricose veinAnesthesia

Outcome Measures

Primary Outcomes (1)

  • The primary outcome is morphine-equivalent use from the end of surgery until the first post-operative morning.

    first post operative morning

Secondary Outcomes (1)

  • 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 Arms (2)

1

ACTIVE COMPARATOR

Patients will receive propofol anesthesia during varicose vein stripping surgery.

Drug: propofol

2

ACTIVE COMPARATOR

Patients will receive sevoflurane anesthesia during varicose vein stripping surgery.

Drug: sevoflurane

Interventions

propofol anesthesia 3-5mg/kg

Also known as: Diprivan
1

sevoflurane anesthesia

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants will undergo a stripping operation for varicose veins
  • Surgery will be performed by one physician only
  • Written informed consent

You may not qualify if:

  • Any contraindications to the proposed interventions
  • Procedures done under regional anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Olga Plattner , MD

Vienna, Austria

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Varicose VeinsPain, Postoperative

Interventions

PropofolSevoflurane

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsMethyl EthersEthersHydrocarbons, FluorinatedHydrocarbons, Halogenated

Study Officials

  • Olga Plattner, MD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2008

First Posted

July 10, 2008

Study Start

September 1, 2010

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

July 20, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations