LoopLido: Lidocaine and Closed-Loop Anesthesia System

• Sponsor: Hopital Foch (Other)
• Overall Status: Completed
• CT.gov ID: NCT01154738
• Collaborator: (none)
• Enrollment: 82
• Location: 1
• Arms: 2
• Duration (Months): 48
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Anesthesia	Drug: Lidocaine; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 82 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Influence of Lidocaine on a Closed-Loop Anesthesia System
• Study Start Date: Jan 1, 2011
• Actual Primary Completion Date: Jan 1, 2015
• Actual Study Completion Date: Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lidocaine Patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and Lidocaine	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 Comparator: Placebo patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and a placebo	Drug: 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

Outcome Measures

Primary Outcome Measures

1. administered dose of propofol during maintenance of anesthesia [day 1]

Secondary Outcome Measures

1. administered dose of propofol during induction of anesthesia [day 1]

2. administered doses of remifentanil during induction and maintenance of anesthesia [day 1]

3. delay (measured as minutes) between the end of propofol and remifentanil administration and the recovery from anesthesia [day 1]

4. hemodynamic abnormalities requiring treatment [day 1]

5. % of time with a BIS index between 40 and 60 [day 1]

6. postoperative morphine requirement [day 1]

7. incidence of postoperative nausea and vomiting [day 1]

8. % of patients with an explicit memorisation of the intraoperative period [second postoperative day]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hopital Tenon	Paris		France	75020

Sponsors and Collaborators

• Hopital Foch

Investigators

• Study Chair: Marc Fischler, MD, Hôpital Foch

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hopital Foch
• ClinicalTrials.gov Identifier: NCT01154738
• Other Study ID Numbers: 2010/18; 2010-019979-29
• First Posted: Jul 1, 2010
• Last Update Posted: Nov 3, 2016
• Last Verified: Nov 1, 2016

• Additional relevant MeSH terms: Lidocaine

Study Results

No Results Posted as of Nov 3, 2016