drugset / Trial / NCT02484651

Can Adequacy of Anesthesia Depth and Quality of Recovery be Influenced by the Level of Neuromuscular Blockade?

NCT02484651 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

The investigators hypothesize that an anesthetic protocol maintaining deep neuromuscular block throughout the entire surgical procedure followed by sugammadex reversal, would suppress EMG activity and result in improved anesthetic stability by reducing the variability of the Bispectral Index of the EEG, and be beneficial by reducing the total doses of the anesthetic drugs propofol and remifentanil required to maintain an adequate level of anesthesia (BIS between 40 and 60).

Timeline

Start
2016-09
Primary completion
2017-06-28
Completion
2017-07-01

Outcome

Mixed primary results

registry analysis (superiority test); Standard Group vs Deep NMB Group; p = 0.651; t-test, 2 sided NCT02484651 ↗

registry MEAN Standard Group: Propofol: 3000 (Standard Deviation 560) ng/ml NCT02484651 ↗

registry MEAN Deep NMB Group: Propofol: 2450 (Standard Deviation 550) ng/ml NCT02484651 ↗

registry analysis (superiority test); Standard Group vs Deep NMB Group; p <0.001; t-test, 2 sided NCT02484651 ↗

registry analysis (superiority test); Standard Group vs Deep NMB Group; p = 0.245; t-test, 2 sided NCT02484651 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Rocuronium Other / unclassified 10 ug/kg —
Subject Rocuronium Other / unclassified 15 ug/kg —
Subject Sugammadex Other / unclassified 4 mg/kg —

Indications