Best Management of Muscle Relaxation- Objective Monitoring

NCT03958201 | Completed Phase 4 Results FDA Drug

• 1 other identifier: STUDY00007084
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Residual Paralysis, Post Anesthesia

Outcome Measures

Primary Outcomes (1)

• Incidence of Postoperative Residual Neuromuscular Blockade at Time of Extubation

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

  Within two minutes of extubation

Secondary Outcomes (1)

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

  Within two minutes of extubation

Study Arms (1)

Protocol

OTHER

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

Interventions

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

Protocol

Eligibility Criteria

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

You may qualify if:

• Are 18 years or older
• Undergoing surgery expected to last less than 6 hours at HMC or UWMC
• Have ASA physical status I-III
• Scheduled to have general anesthesia with at least 1 dose of nondepolarizing NMBD for endotracheal intubation or intraoperative neuromuscular block (NMB)

You may not qualify if:

• Allergy to NMBDs, neostigmine, or sugammadex
• Patients with neuromuscular disease (myasthenia gravis or muscular dystrophy)
• Pregnant or lactating women
• Non English speaking
• Unable to provide informed consent
• Severe renal failure with eGFR less than 20 ml/min

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Related Publications (1)

• Thilen SR, Sherpa JR, James AM, Cain KC, Treggiari MM, Bhananker SM. Management of Muscle Relaxation With Rocuronium and Reversal With Neostigmine or Sugammadex Guided by Quantitative Neuromuscular Monitoring. Anesth Analg. 2024 Sep 1;139(3):536-544. doi: 10.1213/ANE.0000000000006511. Epub 2023 May 12.

  PMID: 37171989 DERIVED

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Interventions

Clinical Protocols; Neostigmine; Sugammadex

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Epidemiologic Study Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Research Coordinator
• Organization: University of Washington

ajames1@uw.edu

206-744-4634

Study Officials

• Stephan R Thilen, MD

  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: Assistant Professor, School of Medicine: Anesthesiology & Pain Medicine

Study Record Dates

• First Submitted: May 17, 2019
• First Posted: May 21, 2019
• Study Start: May 28, 2019
• Primary Completion: January 31, 2020
• Study Completion: March 31, 2020
• Last Updated: November 2, 2022
• Results First Posted: November 2, 2022

Record last verified: 2022-10

Locations

US (1)