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Best Management of Muscle Relaxation- Objective Monitoring

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ClinicalTrials.gov Identifier: NCT03958201
Recruitment Status : Active, not recruiting
First Posted : May 21, 2019
Last Update Posted : February 18, 2020
Sponsor:
Information provided by (Responsible Party):
Stephan Thilen, University of Washington

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.


Condition or disease Intervention/treatment Phase
Residual Paralysis, Post Anesthesia Combination Product: Protocol for Management of Muscle Relaxation With Rocuronium Using Objective Monitoring and Reversal With Neostigmine or Sugammadex Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Best Management of Muscle Relaxation With Rocuronium Using Objective Monitoring and Reversal With Neostigmine or Sugammadex
Actual Study Start Date : May 28, 2019
Actual Primary Completion Date : January 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Paralysis

Arm Intervention/treatment
Protocol
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
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 extubation [ Time Frame: Within two minutes of extubation ]
    Train-of-four ratio <0.9 as measured by electromyography or <1.0 measured by acceleromyography


Secondary Outcome Measures :
  1. Incidence of postoperative severe residual neuromuscular blockade at time of extubation [ Time Frame: Within two minutes of extubation ]
    Train-of-four ratio <0.7 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:

  • 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)

Exclusion Criteria:

  • 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

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): NCT03958201


Locations
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United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
Investigators
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Principal Investigator: Stephan R Thilen, MD University of Washington
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Responsible Party: Stephan Thilen, Assistant Professor, School of Medicine: Anesthesiology & Pain Medicine, University of Washington
ClinicalTrials.gov Identifier: NCT03958201    
Other Study ID Numbers: STUDY00007084
First Posted: May 21, 2019    Key Record Dates
Last Update Posted: February 18, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Paralysis
Delayed Emergence from Anesthesia
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Rocuronium
Neostigmine
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Parasympathomimetics
Autonomic Agents