Lidocaine and Closed-Loop Anesthesia System

Anesthesia Clinical Trial

— LoopLido  

Official title:

Influence of Lidocaine on a Closed-Loop Anesthesia System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01154738
• Other study ID #: 2010/18
• Secondary ID: 2010-019979-29
• Status: Completed
• Phase: Phase 3
• First received: June 25, 2010
• Last updated: November 2, 2016
• Start date: January 2011
• Est. completion date: January 2015

Study information

• Verified date: November 2016
• Source: Hopital Foch
• 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• Lidocaine
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
• Placebo
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

Locations

Country	Name	City	State
France	Hopital Tenon	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	administered dose of propofol during maintenance of anesthesia		day 1	No
Secondary	administered dose of propofol during induction of anesthesia		day 1	No
Secondary	administered doses of remifentanil during induction and maintenance of anesthesia		day 1	No
Secondary	delay (measured as minutes) between the end of propofol and remifentanil administration and the recovery from anesthesia		day 1	No
Secondary	hemodynamic abnormalities requiring treatment		day 1	No
Secondary	% of time with a BIS index between 40 and 60		day 1	No
Secondary	postoperative morphine requirement		day 1	No
Secondary	incidence of postoperative nausea and vomiting		day 1	No
Secondary	% of patients with an explicit memorisation of the intraoperative period		second postoperative day	No