Sugarecovery: Recovery Effect of Sugammadex Measured by Bispectral and Neurosense Indices
Study Details
Study Description
Brief Summary
It has been demonstrated that antagonism of neuromuscular blockade (neostigmine 0.04 mg kg-1) affects depth of anaesthesia with an increase in bispectral index (mean maximal change of 7.1) and middle-latency auditory evoked potentials (mean maximal change of 9.7).
Sugammadex has a quicker and more complete effect than neostigmine. This study aims to demonstrate if sugammadex administration increases bispectral and neurosense indices of the depth of anesthesia while patients still receive propofol-remifentanil iv anesthesia.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Sugammadex - Nacl 9/00 Sugammadex - Nacl 9/00: Patients will first receive sugammadex: 4 mg/kg when post tetanic count shows at least 1 or 2 responses; 2 mg/kg when Train of four shows at least 2 responses. In case of complete reversal of myorelaxation, total intravenous anesthesia is stopped and patients are allowed to awake. In the adverse case, patients wil receive Nacl 9/00 5 minutes after the first bolus of sugammadex. The study is finished 5 minutes after this second injection and care is let to the choice of the anesthesiologist in charge. |
Drug: Sugammadex - Nacl 9/00
Sugammadex: 4 mg/kg when post tetanic count shows at least 1 or 2 responses; 2 mg/kg when Train of four shows at least 2 responses.
Nacl 9/00: same volume as Sugammadex
Other Names:
|
| Experimental: Nacl 9/00 - sugammadex Nacl 9/00 - Sugammadex : Patients wil first receive Nacl 9/00. In case of complete reversal of myorelaxation, total intravenous anesthesia is stopped and patients are allowed to awake. In the adverse case, patients wil receive sugammadex 5 minutes after the first bolus of Nacl 9/00. Sugammadex is given as: 4 mg/kg when post tetanic count shows at least 1 or 2 responses; 2 mg/kg when Train of four shows at least 2 responses. The study is finished 5 minutes after the injection of sugammadex and care is let to the choice of the anesthesiologist in charge. |
Drug: Nacl 9/00 - sugammadex
Nacl 9/00: same volume as Sugammadex
Sugammadex: 4 mg/kg when post tetanic count shows at least 1 or 2 responses; 2 mg/kg when Train of four shows at least 2 responses.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- modification of bispectral and neurosenses indices following sugammadex injection [day 1 after anesthesia]
Secondary Outcome Measures
- efficacy of sugammadex to reverse myorelaxation [day 1 after anesthesia]
- clinical signs of recovery after sugammadex injection [day 1 after anesthesia]
- residual myorelaxation in the post-anesthesia care unit [day 1 after anesthesia]
- score of White and Song during the three first postoperative hours [day 1 after anesthesia]
- duration of stay in the postanesthesia care unit [day 1 after anesthesia]
- occurence of explicit memorisation [day 1 after anesthesia]
Eligibility Criteria
Criteria
Inclusion Criteria:
- patients scheduled to receive general anesthesia with muscle relaxation
Exclusion Criteria:
-
contra-indication to the administration of propofol, remifentanil, rocuronium and to the use of the Bispectral Index or NeuroSense monitor
-
known drug allergy or hypersensitivity to a drug used in the study
-
history of central brain injury
-
patient treated with a psychotropic agent
-
patient with a pacemaker
-
severe renal insufficiency
-
treatment by toremifene, flucloxacillin or fusidic acid in the preoperative or immediate postoperative period
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hopital Foch | Suresnes | France | 92151 |
Sponsors and Collaborators
- Hopital Foch
Investigators
- Study Chair: Marc Fischler, MD, Hopital Foch
Study Documents (Full-Text)
None provided.More Information
Publications
- 2010/01