Recovery Effect of Sugammadex Measured by Bispectral and Neurosense Indices

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Study of EEG Signs of Awakening Secondary to Injection of Sugammadex: Evaluation by Recording Bispectral Index and NeuroSENSE (Prospective, Double-blind Study)

Conditions
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Anesthesia

Intervention / Treatment
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* Drug: Sugammadex - Nacl 9/00
* Drug: Nacl 9/00 - sugammadex


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sugammadex - Nacl 9/00<br>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<br>* 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<br>* Other names: Sugammadex: Bridion;|
| Experimental: Nacl 9/00 - sugammadex<br>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<br>* 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.<br>* Other names: Sugammadex: Bridion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| modification of bispectral and neurosenses indices following sugammadex injection |  | day 1 after anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |