Pilot study of electroencephalographic signs of awakening following sugammadex injection: evaluation by recording of the Bispectral Index and NeuroSENSE (prospective, randomized, single-center, double-blind study) - Suggamadex-Réveil

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Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2010
INTERVENTION: Trade Name: Bridion Product Name: Bridion Pharmaceutical Form: Solution for injection Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use CONDITION: general anesthesia ; MedDRA version: 9.1 Level: LLT Classification code 10002323 Term: Anesthesia general PRIMARY OUTCOME: Main Objective: Main objective is to study bispectral index response to suggamadex injection while patients are still anesthetized.; Primary end point(s): Increase in bispectral index following suggamadex injection Secondary Objective: Secondary objectives are; ‐ efficacy of suggamadex,; ‐ clinical signs of recovery,; ‐ blood concentrations of propofol and remifentanil before and after suggamadex injection,; ‐ quality of the stay in the recovery room. INCLUSION CRITERIA: Patients scheduled for general anesthesia Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes
Epistemonikos ID: f183f742d5d6ca229c8310e9a9fd40d416213e25
First added on: Aug 22, 2024
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