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Best Practice Using Rocuronium and Reversal With Neostigmine or Sugammadex

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ClinicalTrials.gov Identifier: NCT03543826
Recruitment Status : Recruiting
First Posted : June 1, 2018
Last Update Posted : June 14, 2018
Sponsor:
Information provided by (Responsible Party):
Stephan Thilen, University of Washington

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.

Condition or disease Intervention/treatment Phase
Muscle Weakness Other: Protocol for rocuronium neuromuscular block Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Best Practice With Rocuronium, Neostigmine, Sugammadex, and Subjective Monitoring.
Actual Study Start Date : May 21, 2018
Estimated Primary Completion Date : November 20, 2018
Estimated Study Completion Date : November 20, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Protocol
Patients will have perioperative nuromuscular 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 subjectively at adductor pollicis with standard train-of-four stimulation of the ulnar nerve.
Other: 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.




Primary Outcome Measures :
  1. Incidence of postoperative residual neuromuscular blockade at time of arrival to the post-anesthesia care unit. [ Time Frame: Within five minutes of arrival to the post-anesthesia care unit. ]
    Train-of-four ratio <0.9 as measured by electromyography


Secondary Outcome Measures :
  1. Incidence of postoperative severe residual neuromuscular blockade at time of arrival to the post-anesthesia care unit. [ Time Frame: Within five minutes of arrival to the post-anesthesia care unit. ]
    Train-of-four ratio <0.7 as measured by electromyography

  2. Incidence of postoperative residual neuromuscular blockade at time of tracheal extubation. [ Time Frame: Within two minutes of time of extubation. ]
    Train-of-four ratio <0.9 as measured by electromyography.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03543826


Contacts
Contact: Stephan R Thilen, MD, MS 206-744-4371 sthilen@uw.edu
Contact: Sanjay M Bhananker, MD 206-744-7215 sbhanank@uw.edu

Locations
United States, Washington
University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98195
Contact: Stephan Thilen    206-618-2402    sthilen@uw.edu   
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Stephan R Thilen, MD, MS University of Washington

Responsible Party: Stephan Thilen, Associate Professor, University of Washington
ClinicalTrials.gov Identifier: NCT03543826     History of Changes
Other Study ID Numbers: STUDY00003888
First Posted: June 1, 2018    Key Record Dates
Last Update Posted: June 14, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Stephan Thilen, University of Washington:
neostigmine
sugammadex
rocuronium
neuromuscular blocking agents

Additional relevant MeSH terms:
Muscular Diseases
Neuromuscular Manifestations
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Muscle Weakness
Paresis
Musculoskeletal Diseases
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Signs and Symptoms
Rocuronium
Neostigmine
Peripheral Nervous System Agents
Physiological Effects of Drugs
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Parasympathomimetics
Autonomic Agents