Best Practice Using Rocuronium and Reversal With Neostigmine or Sugammadex

NCT03543826 | Completed Phase 4 Results FDA Drug

• 1 other identifier: STUDY00003888
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Muscle Weakness

Keywords

neostigmine; sugammadex; rocuronium; neuromuscular blocking agents

Outcome Measures

Primary Outcomes (1)

• Incidence of Postoperative Residual Neuromuscular Blockade at Time 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.

  Within five minutes of arrival to the post-anesthesia care unit.

Secondary Outcomes (3)

• Incidence of Postoperative Severe Residual Neuromuscular Blockade at Time of Arrival to the Post-anesthesia Care Unit.

  Within five minutes of arrival to the post-anesthesia care unit.

• Incidence of Postoperative Residual Neuromuscular Blockade at Time of Tracheal Extubation.

  Within two minutes of time of extubation.

• Incidence of Postoperative Severe Residual Neuromuscular Blockade at Time of Tracheal Extubation

  Within two minutes of time of extubation.

Study Arms (1)

Subjects undergoing orthopedic or abdominal surgery

OTHER

Subjects undergoing orthopedic or abdominal surgery requiring neuromuscular blockade. Subjects all receive the neuromuscular blockade drug Rocuronium based on study protocol. Depending on depth of block (subjectively assessed by TOF response), Neostigmine, Sugammadex, or no reversal drug is used to reverse block prior to extubation.

Combination Product: Protocol for rocuronium neuromuscular block

Interventions

Protocol for rocuronium neuromuscular block COMBINATION_PRODUCT

The protocol includes specified appropriate rocuronium dosing and a valid pre-reversal assessment of the adductor pollicis response guides optimal neostigmine vs. sugammadex reversal.

Subjects undergoing orthopedic or abdominal surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Related Publications (1)

• Thilen SR, Liang T, Kruse TN, Cain KC, Treggiari MM, Bhananker SM. Evaluation of a Protocol for the Management of Maintenance and Reversal of Rocuronium Block Using Neostigmine or Sugammadex. Anesth Analg. 2023 Jun 1;136(6):1143-1153. doi: 10.1213/ANE.0000000000006510. Epub 2023 May 19.

  PMID: 37205804 DERIVED

MeSH Terms

Conditions

Muscle Weakness

Interventions

Clinical Protocols

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Epidemiologic Study Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Adrienne James
• Organization: University of Washington

ajames1@uw.edu

206-744-4634

Study Officials

• Stephan R Thilen, MD, MS

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 21, 2018
• First Posted: June 1, 2018
• Study Start: May 21, 2018
• Primary Completion: November 26, 2018
• Study Completion: November 26, 2018
• Last Updated: November 9, 2022
• Results First Posted: November 9, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)