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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00146926
Other study ID # 2004.367
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received September 5, 2005
Last updated April 26, 2007
Start date September 2005

Study information

Verified date April 2007
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 200
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind


Related Conditions & MeSH terms

  • Induction of Total Intravenous General Anesthesia

Intervention

Drug:
kétamine 20mg

ephedrine 3mg

lidocaine 40mg


Locations

Country Name City State
France Grégoire CHATAIN Lyon

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary After prophylactic solution, evaluation of the pain caused by injection of propofol with a four-point scale before lose of consciousness
Secondary Explicite and implicite memory of pain immediately after surgery and on day one
Secondary Adverse effects