Recovery Effect of Sugammadex Measured by Bispectral and Neurosense Indices

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-08-31

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.

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Detailed Description

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Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Sugammadex - Nacl 9/00

Intervention Type DRUG

* 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

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.

Group Type EXPERIMENTAL

Nacl 9/00 - sugammadex

Intervention Type DRUG

* 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.

Interventions

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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

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Sugammadex: Bridion Sugammadex: Bridion

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No