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
Sponsor:
Information provided by:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00146926
First received: September 5, 2005
Last updated: April 26, 2007
Last verified: April 2007
  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-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
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov 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:
Propofol
pain
general anesthesia
prevention

Additional relevant MeSH terms:
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on September 18, 2014