NCT01154738
Completed
Phase 3
Influence of Lidocaine on a Closed-Loop Anesthesia System
ConditionsAnesthesia
Overview
- Phase
- Phase 3
- Intervention
- Lidocaine
- Conditions
- Anesthesia
- Sponsor
- Hopital Foch
- Enrollment
- 82
- Locations
- 1
- Primary Endpoint
- administered dose of propofol during maintenance of anesthesia
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The objective is to evaluate the sparing effect of Lidocaine on doses of propofol and remifentanil.
Investigators
Eligibility Criteria
Inclusion Criteria
- •patients ASA 1, 2 or 3 scheduled for a general anesthesia surgical procedure (abdominal surgery, urology, ENT major procedure) lasting between 1 and 3 hours
Exclusion Criteria
- •age under 18 years
- •simultaneous general and loco-regional anesthesia
- •allergy to NSAID
- •treatment with verapamil, ketamine or gabapentin
- •patients receiving an opioid preoperatively
- •severe hepatic insufficiency
- •contra-indication to lidocaine
- •contra-indication to propofol or to remifentanil
- •history of central nervous system disease
- •patients receiving a psychotropic treatment
Arms & Interventions
Lidocaine
Patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and Lidocaine
Intervention: Lidocaine
Placebo
patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and a placebo
Intervention: Placebo
Outcomes
Primary Outcomes
administered dose of propofol during maintenance of anesthesia
Time Frame: day 1
Secondary Outcomes
- delay (measured as minutes) between the end of propofol and remifentanil administration and the recovery from anesthesia(day 1)
- postoperative morphine requirement(day 1)
- incidence of postoperative nausea and vomiting(day 1)
- % of patients with an explicit memorisation of the intraoperative period(second postoperative day)
- administered dose of propofol during induction of anesthesia(day 1)
- administered doses of remifentanil during induction and maintenance of anesthesia(day 1)
- hemodynamic abnormalities requiring treatment(day 1)
- % of time with a BIS index between 40 and 60(day 1)
Study Sites (1)
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