Anesthesia
Conditions
Brief summary
The objective is to evaluate the sparing effect of Lidocaine on doses of propofol and remifentanil.
Interventions
DRUGLidocaine
bolus dose of lidocaine (1.5 mg.kg-1) followed by an infusion of lidocaine (2 mg.kg-1 h-1) until the end of anesthesia. start of the induction of anesthesia 10 minutes after the bolus dose of lidocaine
DRUGPlacebo
NaCl 9/00 (same volume as in the lidocaine group) start of the induction of anesthesia 10 minutes after the bolus dose of NaCl 9/00
Sponsors
Hopital Foch
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 * patients with a pace-maker
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| administered dose of propofol during maintenance of anesthesia | day 1 |
Secondary
| Measure | Time frame |
|---|---|
| administered doses of remifentanil during induction and maintenance of anesthesia | day 1 |
| delay (measured as minutes) between the end of propofol and remifentanil administration and the recovery from anesthesia | day 1 |
| hemodynamic abnormalities requiring treatment | day 1 |
| administered dose of propofol during induction of 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 |
| % of time with a BIS index between 40 and 60 | day 1 |
Countries
France
Outcome results
None listed