Lidocaine and Closed-Loop Anesthesia System (LoopLido)
This study has been completed.
Sponsor:
Hopital Foch
Information provided by (Responsible Party):
Hopital Foch
ClinicalTrials.gov Identifier:
NCT01154738
First received: June 25, 2010
Last updated: September 22, 2016
Last verified: September 2016
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Purpose
The objective is to evaluate the sparing effect of Lidocaine on doses of propofol and remifentanil.
| Condition | Intervention | Phase |
|---|---|---|
|
Anesthesia |
Drug: Lidocaine Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Influence of Lidocaine on a Closed-Loop Anesthesia System |
Resource links provided by NLM:
Further study details as provided by Hopital Foch:
Primary Outcome Measures:
- administered dose of propofol during maintenance of anesthesia [ Time Frame: day 1 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- administered dose of propofol during induction of anesthesia [ Time Frame: day 1 ] [ Designated as safety issue: No ]
- administered doses of remifentanil during induction and maintenance of anesthesia [ Time Frame: day 1 ] [ Designated as safety issue: No ]
- delay (measured as minutes) between the end of propofol and remifentanil administration and the recovery from anesthesia [ Time Frame: day 1 ] [ Designated as safety issue: No ]
- hemodynamic abnormalities requiring treatment [ Time Frame: day 1 ] [ Designated as safety issue: No ]
- % of time with a BIS index between 40 and 60 [ Time Frame: day 1 ] [ Designated as safety issue: No ]
- postoperative morphine requirement [ Time Frame: day 1 ] [ Designated as safety issue: No ]
- incidence of postoperative nausea and vomiting [ Time Frame: day 1 ] [ Designated as safety issue: No ]
- % of patients with an explicit memorisation of the intraoperative period [ Time Frame: second postoperative day ] [ Designated as safety issue: No ]
| Enrollment: | 82 |
| Study Start Date: | January 2011 |
| Study Completion Date: | January 2015 |
| Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01154738
Please refer to this study by its ClinicalTrials.gov identifier: NCT01154738
Locations
| France | |
| Hopital Tenon | |
| Paris, France, 75020 | |
Sponsors and Collaborators
Hopital Foch
Investigators
| Study Chair: | Marc Fischler, MD | Hôpital Foch |
More Information
| Responsible Party: | Hopital Foch |
| ClinicalTrials.gov Identifier: | NCT01154738 History of Changes |
| Other Study ID Numbers: | 2010/18 |
| Study First Received: | June 25, 2010 |
| Last Updated: | September 22, 2016 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Additional relevant MeSH terms:
|
Anesthetics Lidocaine Central Nervous System Depressants Physiological Effects of Drugs Anesthetics, Local Sensory System Agents |
Peripheral Nervous System Agents Anti-Arrhythmia Agents Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 23, 2016