Lidocaine and Closed-Loop Anesthesia System (LoopLido)
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ClinicalTrials.gov Identifier: NCT01154738 |
Recruitment Status :
Completed
First Posted : July 1, 2010
Last Update Posted : November 3, 2016
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Condition or disease | Intervention/treatment | Phase |
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Anesthesia | Drug: Lidocaine Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
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 : | January 2011 |
Actual Primary Completion Date : | January 2015 |
Actual Study Completion Date : | January 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: Lidocaine
Patients will receive a closed-loop administration of propofol and remifentanil according to bispectral level and Lidocaine
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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
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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 |
- administered dose of propofol during maintenance of anesthesia [ Time Frame: day 1 ]
- administered dose of propofol during induction of anesthesia [ Time Frame: day 1 ]
- administered doses of remifentanil during induction and maintenance of anesthesia [ Time Frame: day 1 ]
- delay (measured as minutes) between the end of propofol and remifentanil administration and the recovery from anesthesia [ Time Frame: day 1 ]
- hemodynamic abnormalities requiring treatment [ Time Frame: day 1 ]
- % of time with a BIS index between 40 and 60 [ Time Frame: day 1 ]
- postoperative morphine requirement [ Time Frame: day 1 ]
- incidence of postoperative nausea and vomiting [ Time Frame: day 1 ]
- % of patients with an explicit memorisation of the intraoperative period [ Time Frame: second postoperative day ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01154738
France | |
Hopital Tenon | |
Paris, France, 75020 |
Study Chair: | Marc Fischler, MD | Hôpital Foch |
Responsible Party: | Hopital Foch |
ClinicalTrials.gov Identifier: | NCT01154738 |
Other Study ID Numbers: |
2010/18 2010-019979-29 ( EudraCT Number ) |
First Posted: | July 1, 2010 Key Record Dates |
Last Update Posted: | November 3, 2016 |
Last Verified: | November 2016 |
Lidocaine Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs 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 |