Comparison of Three Different Strategies to Prevent Propofol Induced Pain During Infusion

Brief Summary

Propofol is a popular intravenous drug to induce anesthesia but it causes local pain with an incidence between 40 and 90%. Three different strategies to prevent propofol induced pain will be studied compared with placebo. Pain will be scored with a four-point scale.

Intervention / Treatment

  • kétamine 20mg (DRUG)
    N/A
  • ephedrine 3mg (DRUG)
    N/A
  • lidocaine 40mg (DRUG)
    N/A

Condition or Disease

  • Induction of Total Intravenous General Anesthesia

Phase

  • Phase 3
  • Study Design

    Study type: INTERVENTIONAL
    Status: Unknown status
    Study results: No Results Available
    Age: 18 Years to 75 Years
    Enrollment: 200 ()
    Funded by: Other
    Allocation: Randomized

    Masking

    Clinical Trial Dates

    Start date: Sep 01, 2005
    Primary Completion: Aug 31, 2020
    Completion Date: Aug 31, 2020
    Study First Posted: Sep 07, 2005 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Apr 26, 2007

    Sponsors / Collaborators

    Lead Sponsor: Hospices Civils de Lyon
    Responsible Party: N/A
    No responsible party listed

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 75
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    Healthy adults (ASA 1-2) for scheduled surgery under general anesthesia with propofol

    Exclusion Criteria:

    * pregnant
    * sedative or analgesic drug 24h before surgery
    * allergy with drug used in the study
    * difficulty of communication
    * absence of informed written consent

    Primary Outcomes
    • After prophylactic solution, evaluation of the pain caused by injection of propofol with a four-point scale before lose of consciousness
    Secondary Outcomes
    • Explicite and implicite memory of pain immediately after surgery and on day one
    • Adverse effects

    More Details

    NCT Number: NCT00146926
    Other IDs: 2004.367
    Study URL: https://clinicaltrials.gov/study/NCT00146926
    Last updated: Sep 29, 2023