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TerminatedNCT00712517Updated Jul 20, 2016

Propofol Versus Volatile Anesthesia in Post Operative Pain Management

An interventional study of propofol and sevoflurane in Varicose Vein and Postoperative Pain, sponsored by The Cleveland Clinic. Terminated at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-07-20.

Sponsored by The Cleveland Clinic · Not applicable, Interventional, and Prevention

Why this study was terminated
Enrolling of participants has halted and the results are being gathered
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Varicose Vein
  • Postoperative Pain

Keywords

  • postoperative pain
  • Piritramid
  • propofol
  • sevoflurane
  • varicose vein
  • Anesthesia
03

In context

Varicose Veins

253 studies on the registry are indexed under Varicose Veins; 35 are open to participants now.

This study's enrollment of 90 is below the median of 104 across 162 interventional studies indexed under Varicose Veins.

Browse Varicose Veins studies →

Lead sponsor

The Cleveland Clinic is the lead sponsor of 818 studies on the registry; 118 are open to participants now.

Of its 89 completed or terminated interventional studies of FDA-regulated products, 72 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Any contraindications to the proposed interventions
  • Procedures done under regional anesthesia
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (actual)

Study arms

  • Active comparator
    1

    Patients will receive propofol anesthesia during varicose vein stripping surgery.

    Drug: propofol

  • Active comparator
    2

    Patients will receive sevoflurane anesthesia during varicose vein stripping surgery.

    Drug: sevoflurane

Interventions

  • Drugpropofol

    propofol anesthesia 3-5mg/kg

    Also known as: Diprivan

  • Drugsevoflurane

    sevoflurane anesthesia

06

What researchers measure

Primary outcomes

  1. 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

  1. 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

07

Study locations

1 site
  • Olga Plattner , MD
    Vienna, Austria
08

References and documents

Publications

  • 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. PubMed 27638296 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00712517
Lead sponsor
The Cleveland Clinic
Responsible party
Sponsor
First posted
Jul 10, 2008
Start date
Sep 2010
Primary completion
May 2014
Completion
May 2014
Last update
Jul 20, 2016

Study contacts

Olga Plattner, MD
principal investigator · Medical University of Vienna

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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