Lidocaine and Closed-Loop Anesthesia System
LoopLido
Influence of Lidocaine on a Closed-Loop Anesthesia System
2 other identifiers
interventional
82
1 country
1
Brief Summary
The objective is to evaluate the sparing effect of Lidocaine on doses of propofol and remifentanil.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2011
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 25, 2010
CompletedFirst Posted
Study publicly available on registry
July 1, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedNovember 3, 2016
November 1, 2016
4 years
June 25, 2010
November 2, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
administered dose of propofol during maintenance of anesthesia
day 1
Secondary Outcomes (8)
administered dose of propofol during induction of anesthesia
day 1
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
% of time with a BIS index between 40 and 60
day 1
- +3 more secondary outcomes
Study Arms (2)
Lidocaine
EXPERIMENTALPatients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and Lidocaine
Placebo
PLACEBO COMPARATORpatients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and a placebo
Interventions
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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hopital Fochlead
Study Sites (1)
Hopital Tenon
Paris, 75020, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Marc Fischler, MD
Hôpital Foch
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2010
First Posted
July 1, 2010
Study Start
January 1, 2011
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
November 3, 2016
Record last verified: 2016-11