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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Hospices Civils de Lyon.
Recruitment status was  Active, not recruiting
Information provided by:
Hospices Civils de Lyon Identifier:
First received: September 5, 2005
Last updated: April 26, 2007
Last verified: April 2007
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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Official Title: Comparison of Three Different Strategies to Prevent Propofol Induced Pain During Infusion

Resource links provided by NLM:

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • After prophylactic solution, evaluation of the pain caused by injection of propofol with a four-point scale before lose of consciousness

Secondary Outcome Measures:
  • Explicite and implicite memory of pain immediately after surgery and on day one
  • Adverse effects

Estimated Enrollment: 200
Study Start Date: September 2005

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00146926

Grégoire CHATAIN
Lyon, France, 69495
Sponsors and Collaborators
Hospices Civils de Lyon
Principal Investigator: Vincent PIRIOU, MD Hospices Civils de Lyon
  More Information

No publications provided Identifier: NCT00146926     History of Changes
Other Study ID Numbers: 2004.367 
Study First Received: September 5, 2005
Last Updated: April 26, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hospices Civils de Lyon:
general anesthesia

Additional relevant MeSH terms:
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on February 11, 2016