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


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Safety (General)

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

This study is currently recruiting patients.
Verified by Hospices Civils de Lyon September 2005

Sponsored by: Hospices Civils de Lyon
Information provided by: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT00146926

Purpose

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.
Condition Intervention Phase
Induction of total Intravenous general anesthesia
  Drug: kétamine 20mg
 Drug: ephedrine 3mg
 Drug: lidocaine 40mg
 Phase III

MedlinePlus consumer health information 

Study Type: Interventional
Study Design: Randomized, Double-Blind, Placebo Control, Parallel Assignment

Further Study Details: 
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
Expected Total Enrollment:  200

Study start: September 2005

Eligibility

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both
Criteria

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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00146926

Grégoire CHATAIN, MD      33 478 861 476    gregoire.chatain@chu-lyon.fr

France
      Grégoire CHATAIN, Lyon,  69495,  France; Recruiting
Grégoire CHATAIN, MD  33 478 861 476    gregoire.chatain@chu-lyon.fr 

Study chairs or principal investigators

Vincent PIRIOU, MD,  Principal Investigator,  Hospices Civils de Lyon   

More Information

Study ID Numbers:  2004.367
Last Updated:  September 6, 2005
Record first received:  September 5, 2005
ClinicalTrials.gov Identifier:  NCT00146926
Health Authority: France: Afssaps - French Health Products Safety Agency
ClinicalTrials.gov processed this record on 2005-09-13


Source: ClinicalTrials.gov
Cache Date: September 14, 2005


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Page Updated: September 6, 2005
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