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

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ClinicalTrials.gov Identifier: NCT00146926
Recruitment Status : Unknown
Verified April 2007 by Hospices Civils de Lyon.
Recruitment status was:  Active, not recruiting
First Posted : September 7, 2005
Last Update Posted : April 27, 2007
Sponsor:
Information provided by:
Hospices Civils de Lyon

Tracking Information
First Submitted Date  ICMJE September 5, 2005
First Posted Date  ICMJE September 7, 2005
Last Update Posted Date April 27, 2007
Study Start Date  ICMJE September 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2005)
After prophylactic solution, evaluation of the pain caused by injection of propofol with a four-point scale before lose of consciousness
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2005)
  • Explicite and implicite memory of pain immediately after surgery and on day one
  • Adverse effects
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Three Different Strategies to Prevent Propofol Induced Pain During Infusion
Official Title  ICMJE 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Condition  ICMJE Induction of Total Intravenous General Anesthesia
Intervention  ICMJE
  • Drug: kétamine 20mg
  • Drug: ephedrine 3mg
  • Drug: lidocaine 40mg
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: September 5, 2005)
200
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00146926
Other Study ID Numbers  ICMJE 2004.367
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Hospices Civils de Lyon
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Vincent PIRIOU, MD Hospices Civils de Lyon
PRS Account Hospices Civils de Lyon
Verification Date April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP