NCT03543826

Best Practice Using Rocuronium and Reversal With Neostigmine or Sugammadex

Completed Phase 4 Results posted Last updated 9 November 2022

What this trial tests

Phase 4 trial testing Protocol for rocuronium neuromuscular block in Muscle Weakness in 201 participants. Completed in 26 November 2018.

Timeline

21 May 2018

Primary endpoint
26 November 2018

26 November 2018

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	201
Start date	21 May 2018
Primary completion	26 November 2018
Estimated completion	26 November 2018
Sites	1 location across United States

Drugs / interventions tested

• Protocol for rocuronium neuromuscular block

Conditions studied

• Muscle Weakness — all drugs for Muscle Weakness →

Sponsor

University of Washington

Who can join

18 and older, any sex, with Muscle Weakness. 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 Arrival to the Post-anesthesia Care Unit. Primary · Within five minutes of arrival to the post-anesthesia care unit.

Postoperative residual neuromuscular blockade is measured by a Train-of-four ratio \<0.9 as measured by acceleromyography.

Group	Value	95% CI
Subjects Undergoing Orthopedic or Abdominal Surgery	5

Incidence of Postoperative Severe Residual Neuromuscular Blockade at Time of Arrival to the Post-anesthesia Care Unit. Secondary · Within five minutes of arrival to the post-anesthesia care unit.

Postoperative severe residual neuromuscular blockade is measured by a Train-of-four ratio \<0.7 as measured by acceleromyography.

Group	Value	95% CI
Subjects Undergoing Orthopedic or Abdominal Surgery	2

Incidence of Postoperative Residual Neuromuscular Blockade at Time of Tracheal Extubation. Secondary · Within two minutes of time of extubation.

Postoperative residual neuromuscular blockade is measured by a Train-of-four ratio \<0.9 as measured by acceleromyography.

Group	Value	95% CI
Subjects Undergoing Orthopedic or Abdominal Surgery	14

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

Postoperative severe residual neuromuscular blockade is measured by a Train-of-four ratio \<0.7 as measured by acceleromyography.

Group	Value	95% CI
Subjects Undergoing Orthopedic or Abdominal Surgery	1

Sponsor's own description

This is an estimation study, prospectively evaluating the incidence of postoperative residual neuromuscular blockade (PRNB) when a best practice protocol is implemented for a cohort of abdominal surgery and orthopedic surgery patients. The protocol is developed within the constraint of subjective monitoring, quantitative monitoring is not used, and use of rocuronium for paralysis and either neostigmine or sugammadex for reversal. The primary outcome is the incidence of PRNB on arrival to the post-anesthesia care unit, defined as a train-of-four ration \<0.9.

Publications & conference data

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