Overview

This trial is active, not recruiting.

Condition induction of total intravenous general anesthesia
Treatments kétamine 20mg, ephedrine 3mg, lidocaine 40mg
Phase phase 3
Sponsor Hospices Civils de Lyon
Start date September 2005
Trial size 200 participants
Trial identifier NCT00146926, 2004.367

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double-blind

Primary Outcomes

Measure
After prophylactic solution, evaluation of the pain caused by injection of propofol with a four-point scale before lose of consciousness
time frame:

Secondary Outcomes

Measure
Explicite and implicite memory of pain immediately after surgery and on day one
time frame:
Adverse effects
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title Comparison of Three Different Strategies to Prevent Propofol Induced Pain During Infusion
Principal investigator Vincent PIRIOU, MD
Trial information was received from ClinicalTrials.gov and was last updated in April 2007.
Information provided to ClinicalTrials.gov by Hospices Civils de Lyon.