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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

Study Description
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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 Design
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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

Arms and Interventions
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Outcome Measures
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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

Eligibility Criteria
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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov 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:
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