Recovery Effect of Sugammadex Measured by Bispectral and Neurosense Indices (Sugarecovery)

Hopital Foch

Status and phase: Completed; Phase 4

Conditions: Anesthesia

Treatments: Drug: Sugammadex - Nacl 9/00; Drug: Nacl 9/00 - sugammadex

Study type: Interventional

Funder types: Other

Identifiers

NCT01161004

2010/01

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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50 participants in 2 patient groups

Sugammadex - Nacl 9/00

Experimental group

Description:

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.

Treatment:

Drug: Sugammadex - Nacl 9/00

Nacl 9/00 - sugammadex

Experimental group

Description:

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.

Treatment:

Drug: Nacl 9/00 - sugammadex