Lidocaine and Closed-Loop Anesthesia System (LoopLido)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified November 2014 by Hopital Foch
Sponsor:
Hopital Foch
Information provided by (Responsible Party):
Hopital Foch
ClinicalTrials.gov Identifier:
NCT01154738
First received: June 25, 2010
Last updated: November 8, 2014
Last verified: November 2014
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 ]
| Estimated Enrollment: | 80 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | April 2015 |
| Estimated Primary Completion Date: | April 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 |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01154738
Please refer to this study by its ClinicalTrials.gov identifier: NCT01154738
Contacts
| Contact: Marc Fischler Fischler, MD | 46252442 ext 00331 | m.fischler@hopital-foch.org |
Locations
| France | |
| Hopital Tenon | Recruiting |
| Paris, France, 75020 | |
| Contact: Francis Bonnet, MD 56016571 ext 00331 francis.bonnet@tnn.aphp.fr | |
Sponsors and Collaborators
Hopital Foch
Investigators
| Study Chair: | Marc Fischler, MD | Hôpital Foch |
More Information
No publications provided
| 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: | November 8, 2014 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Additional relevant MeSH terms:
|
Anesthetics Lidocaine Anesthetics, Local Anti-Arrhythmia Agents Cardiovascular Agents Central Nervous System Agents Central Nervous System Depressants Membrane Transport Modulators |
Molecular Mechanisms of Pharmacological Action Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Sensory System Agents Sodium Channel Blockers Therapeutic Uses Voltage-Gated Sodium Channel Blockers |
ClinicalTrials.gov processed this record on March 01, 2015