NCT03958201

Best Management of Muscle Relaxation- Objective Monitoring

Completed Phase 4 Results posted Last updated 2 November 2022

What this trial tests

Phase 4 trial testing Protocol for Management of Muscle Relaxation With Rocuronium Using Objective Monitoring and Reversal With Neostigmine or Sugammadex in Residual Paralysis, Post Anesthesia in 200 participants. Completed in 31 March 2020.

Timeline

28 May 2019

Primary endpoint
31 January 2020

31 March 2020

Quick facts

Lead sponsor	University of Washington
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	200
Start date	28 May 2019
Primary completion	31 January 2020
Estimated completion	31 March 2020
Sites	1 location across United States

Drugs / interventions tested

• Protocol for Management of Muscle Relaxation With Rocuronium Using Objective Monitoring and Reversal With Neostigmine or Sugammadex

Conditions studied

• Residual Paralysis, Post Anesthesia — all drugs for Residual Paralysis, Post Anesthesia →

Sponsor

University of Washington

Who can join

18 and older, any sex, with Residual Paralysis, Post Anesthesia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Incidence of Postoperative Residual Neuromuscular Blockade at Time of Extubation Primary · Within two minutes of extubation

Train-of-four ratio \<0.9 as measured by electromyography or \<1.0 measured by acceleromyography

Group	Value	95% CI
Subjects Undergoing Elective Surgery Involving the Intraoperative Use of Rocuronium	0

Incidence of Severe Postoperative Residual Neuromuscular Blockade at Time of Extubation Secondary · Within two minutes of extubation

Train-of-four ratio \<0.7 as measured by electromyography

Group	Value	95% CI
Subjects Undergoing Elective Surgery Involving the Intraoperative Use of Rocuronium	0

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.