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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
Hospices Civils de Lyon

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.

Condition or disease Intervention/treatment Phase
Induction of Total Intravenous General Anesthesia Drug: kétamine 20mg Drug: ephedrine 3mg Drug: lidocaine 40mg Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Official Title: Comparison of Three Different Strategies to Prevent Propofol Induced Pain During Infusion
Study Start Date : September 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol
U.S. FDA Resources

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00146926

Grégoire CHATAIN
Lyon, France, 69495
Sponsors and Collaborators
Hospices Civils de Lyon
Principal Investigator: Vincent PIRIOU, MD Hospices Civils de Lyon Identifier: NCT00146926     History of Changes
Other Study ID Numbers: 2004.367
First Posted: September 7, 2005    Key Record Dates
Last Update Posted: April 27, 2007
Last Verified: April 2007

Keywords provided by Hospices Civils de Lyon:
general anesthesia

Additional relevant MeSH terms:
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics, Dissociative
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Central Nervous System Stimulants
Autonomic Agents
Vasoconstrictor Agents
Adrenergic Agents