Comparison of Three Different Strategies to Prevent Propofol Induced Pain During Infusion
April 26, 2007 updated by: Hospices Civils de Lyon
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.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment
200
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Lyon, France, 69495
- Grégoire CHATAIN
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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After prophylactic solution, evaluation of the pain caused by injection of propofol with a four-point scale before lose of consciousness
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Secondary Outcome Measures
Outcome Measure |
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Explicite and implicite memory of pain immediately after surgery and on day one
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Adverse effects
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Vincent PIRIOU, MD, Hospices Civils de Lyon
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2005
Study Registration Dates
First Submitted
September 5, 2005
First Submitted That Met QC Criteria
September 5, 2005
First Posted (Estimate)
September 7, 2005
Study Record Updates
Last Update Posted (Estimate)
April 27, 2007
Last Update Submitted That Met QC Criteria
April 26, 2007
Last Verified
April 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Dissociative
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Central Nervous System Stimulants
- Sympathomimetics
- Vasoconstrictor Agents
- Ketamine
- Lidocaine
- Ephedrine
Other Study ID Numbers
- 2004.367
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.