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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified April 2007 by Hospices Civils de Lyon.
Recruitment status was: Active, not recruiting

Sponsor:

ClinicalTrials.gov Identifier:

NCT00146926

First Posted: September 7, 2005

Last Update Posted: April 27, 2007

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.

Information provided by:

Hospices Civils de Lyon

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 3


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

Resource links provided by NLM:

Drug Information available for: Propofol

U.S. FDA Resources

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

Eligibility

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

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

Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00146926

Locations


France
Grégoire CHATAIN
Lyon, France, 69495

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators


Principal Investigator:	Vincent PIRIOU, MD	Hospices Civils de Lyon

More Information


ClinicalTrials.gov Identifier:	NCT00146926 History of Changes
Other Study ID Numbers:	2004.367
First Submitted:	September 5, 2005
First Posted:	September 7, 2005
Last Update Posted:	April 27, 2007
Last Verified:	April 2007

Keywords provided by Hospices Civils de Lyon:


Propofol pain general anesthesia prevention

Additional relevant MeSH terms:


Lidocaine Propofol Ketamine Ephedrine Anesthetics, Local Anesthetics 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 Analgesics Anesthetics, Dissociative Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Central Nervous System Stimulants Sympathomimetics Autonomic Agents Vasoconstrictor Agents Adrenergic Agents

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