Best Practice Using Rocuronium and Reversal With Neostigmine or Sugammadex

Best Practice With Rocuronium, Neostigmine, Sugammadex, and Subjective Monitoring.

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.

Study Overview

• Status: Completed
• Conditions: Muscle Weakness
• Intervention / Treatment: Combination product: Protocol for rocuronium neuromuscular block

Detailed Description

This study estimates the incidence of postoperative residual neuromuscular block when rocuronium neuromuscular block is managed by protocol for qualitative monitoring and reversal with neostigmine or sugammadex. The study is an extension of the recently published study by Thilen and co-workers which evaluated a protocol which used neostigmine as the sole reversal agent (doi: 10.1016/j.bja.2018.03.029). It demonstrated that use of a protocol was associated with a reduced incidence of severe residual paralysis, defined as normalized train-of-four (TOF) ratio <0.7 at time of tracheal extubation. It was also associated with a highly significant reduction in PRNB as defined for several secondary outcomes, including non-normalized (i.e. raw) TOF-ratio <0.9 at time of arrival to the post-anesthesia care unit (PACU).

The current study does not include a control group, only an intervention group. The investigators hypothesize that PRNB can be prevented by adhering to a protocol which incorporates several current recommendations by experts. Importantly, the protocol preserves a role for neostigmine when the pre-reversal assessment indicates that spontaneous recovery has progressed to a so-called minimal block which is defined as the subjective absence of fade in the adductor pollicis TOF response. The investigators will study only abdominal surgery and orthopedic surgery patients. The primary outcome is incidence of PRNB, defined as TOF-ratio <0.9 on arrival to the PACU. The investigators plan to enroll 120 patients, and if no more than one patient has PRNB, the upper bound for the 95% confidence interval will be less than 5%.

• Study Type: Interventional
• Enrollment (Actual): 201
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria: Adult 18 years old or older, Will undergo open or laparoscopic abdominal surgery or orthopedic surgery expected to last <6 hours at Harborview or Univ of Wash Med Ctr, Have American Society of Anesthesiologists physical status I-III, scheduled to have general anesthesia with at least 1 dose of nondepolarizing neuromuscular blocking drug for endotracheal intubation or intraoperative neuromuscular blockade.

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Exclusion Criteria: Allergy to neuromuscular blocking drugs, patients with neuromuscular disease (myasthenia gravis or muscular dystrophy), pregnant or lactating women, non-English speaking.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Subjects undergoing orthopedic or abdominal surgery; 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; The protocol includes specified appropriate rocuronium dosing and a valid pre-reversal assessment of the adductor pollicis response guides optimal neostigmine vs. sugammadex reversal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Postoperative Severe Residual Neuromuscular Blockade at Time 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.	Within five minutes of arrival to the post-anesthesia care unit.
Incidence of Postoperative Residual Neuromuscular Blockade at Time of Tracheal Extubation.	Postoperative residual neuromuscular blockade is measured by a Train-of-four ratio <0.9 as measured by acceleromyography.	Within two minutes of time of extubation.
Incidence of Postoperative Severe Residual Neuromuscular Blockade at Time of Tracheal Extubation	Postoperative severe residual neuromuscular blockade is measured by a Train-of-four ratio <0.7 as measured by acceleromyography.	Within two minutes of time of extubation.

Collaborators and Investigators

• Sponsor: University of Washington
• Investigators: Principal Investigator: Stephan R Thilen, MD, MS, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2018
• Primary Completion (Actual): November 26, 2018
• Study Completion (Actual): November 26, 2018

Study Registration Dates

• First Submitted: May 21, 2018
• First Submitted That Met QC Criteria: May 21, 2018
• First Posted (Actual): June 1, 2018

Study Record Updates

• Last Update Posted (Actual): November 9, 2022
• Last Update Submitted That Met QC Criteria: October 14, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: rocuronium; sugammadex; neostigmine; neuromuscular blocking agents
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Weakness; Physiological Effects of Drugs; Peripheral Nervous System Agents; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Rocuronium
• Other Study ID Numbers: STUDY00003888

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No