Recovery Effect of Sugammadex Measured by Bispectral and Neurosense Indices

Phase 4

Completed

• Conditions: Anesthesia
• Interventions: Drug: Sugammadex - Nacl 9/00; Drug: Nacl 9/00 - sugammadex

• Registration Number: NCT01161004
• Lead Sponsor: Hopital Foch

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-09
• Study First Submitted QC: 2010-07-12
• Study First Posted: 2010-07-13
• Study Start: 2010-09
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-23
• Last Update Posted: 2017-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• patients scheduled to receive general anesthesia with muscle relaxation

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sugammadex - Nacl 9/00	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.
Nacl 9/00 - sugammadex	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.

Primary Outcome Measures

Name	Time	Method
modification of bispectral and neurosenses indices following sugammadex injection	day 1 after anesthesia

Secondary Outcome Measures

Name	Time	Method
occurence of explicit memorisation	day 1 after anesthesia
score of White and Song during the three first postoperative hours	day 1 after anesthesia
residual myorelaxation in the post-anesthesia care unit	day 1 after anesthesia
clinical signs of recovery after sugammadex injection	day 1 after anesthesia
duration of stay in the postanesthesia care unit	day 1 after anesthesia
efficacy of sugammadex to reverse myorelaxation	day 1 after anesthesia

Trial Locations

Locations (1)

Hopital Foch; 🇫🇷 Suresnes, France