Best Management of Muscle Relaxation- Objective Monitoring
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|ClinicalTrials.gov Identifier: NCT03958201|
Recruitment Status : Completed
First Posted : May 21, 2019
Results First Posted : November 2, 2022
Last Update Posted : November 2, 2022
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.
|Condition or disease||Intervention/treatment||Phase|
|Residual Paralysis, Post Anesthesia||Combination Product: Protocol for Management of Muscle Relaxation With Rocuronium Using Objective Monitoring and Reversal With Neostigmine or Sugammadex||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Best Management of Muscle Relaxation With Rocuronium Using Objective Monitoring and Reversal With Neostigmine or Sugammadex|
|Actual Study Start Date :||May 28, 2019|
|Actual Primary Completion Date :||January 31, 2020|
|Actual Study Completion Date :||March 31, 2020|
Patients will have perioperative neuromuscular block managed by protocol. The protocol includes specified appropriate rocuronium dosing and reversal with either neostigmine or sugammadex depending on depth of block as assessed objectively at adductor pollicis with quantitative neuromuscular monitoring.
Combination Product: Protocol for Management of Muscle Relaxation With Rocuronium Using Objective Monitoring and Reversal With Neostigmine or Sugammadex
The protocol includes specified appropriate rocuronium dosing and a valid pre-reversal assessment of the adductor pollicis response guides optimal neostigmine vs. sugammadex reversal.
- Incidence of Postoperative Residual Neuromuscular Blockade at Time of Extubation [ Time Frame: Within two minutes of extubation ]Train-of-four ratio <0.9 as measured by electromyography or <1.0 measured by acceleromyography
- Incidence of Severe Postoperative Residual Neuromuscular Blockade at Time of Extubation [ Time Frame: Within two minutes of extubation ]Train-of-four ratio <0.7 as measured by electromyography
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03958201
|United States, Washington|
|Harborview Medical Center|
|Seattle, Washington, United States, 98104|
|Principal Investigator:||Stephan R Thilen, MD||University of Washington|