Lidocaine and Closed-Loop Anesthesia System (LoopLido)

Hopital Foch

Status and phase: Completed; Phase 3

Conditions: Anesthesia

Treatments: Drug: Placebo; Drug: Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT01154738

2010/18

2010-019979-29 (EudraCT Number)

Details and patient eligibility

About

The objective is to evaluate the sparing effect of Lidocaine on doses of propofol and remifentanil.

Enrollment: 82 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

82 participants in 2 patient groups, including a placebo group

Lidocaine

Experimental group

Description:

Patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and Lidocaine

Treatment:

Drug: Lidocaine

Placebo

Placebo Comparator group

Description:

patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and a placebo

Treatment:

Drug: Placebo