drugset / Trial / NCT03958201

Best Management of Muscle Relaxation- Objective Monitoring

NCT03958201

Phase 4 Completed 200 enrolled University of Washington
NaSingle-groupOpen-labelPrevention

Summary

The purpose of this study is to demonstrate that the investigators can reduce residual paralysis to a very low incidence, and that the investigators can do this while preserving a role for the older and less expensive reversal agent neostigmine. The investigators consider this an evidence-based approach because previous reports clearly indicate that neostigmine is effective for reversal of the most shallow neuromuscular blocks, a level of block now referred to as minimal block. The Investigators also know from previous data that a substantial proportion of patients have minimal block. Sugammadex will be used when the block to be reversed is deeper than minimal, specifically when the objectively measured TOF-ratio is \<40%. The investigators hypothesize that this protocol will be associated with an incidence of residual paralysis of less than 3%. The investigators plan is to study 200 patients.

Timeline

Start
2019-05-28
Primary completion
2020-01-31
Completion
2020-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Neostigmine Other / unclassified
Subject Sugammadex Other / unclassified
Background Rocuronium Other / unclassified 0.6 mg/kg

Indications