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Incidence and Severity of Residual Neuromuscular Blockade

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ClinicalTrials.gov Identifier: NCT02660398
Recruitment Status : Completed
First Posted : January 21, 2016
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
Stephan Thilen, University of Washington

Brief Summary:
This prospective study will take place at Harborview Medical Center (HMC) and the University of Washington Medical Center (UWMC), and will enroll adult patients undergoing abdominal surgery. The purpose of this study is to identify if the use of a specific plan to managing muscle relaxants will help decrease the risk of muscle weakness after general anesthesia with muscle relaxation in a population of patients undergoing abdominal surgery.

Condition or disease Intervention/treatment Phase
Residual Neuromuscular Blockade Procedure: Standardized NMBD Management Phase 4

Detailed Description:

80 patients will be enrolled in this prospective study. The first 40 patients will serve as controls and will not have an intervention.

Patients who have surgery and receive general anesthesia often receive muscle relaxants called neuromuscular blocking drugs or NMBDs. NMBDs facilitate anesthesiologists' performance of tracheal intubation, provide muscle relaxation during surgery, and are sometimes administered to prevent movement. After surgery, an anesthesiologist monitors how the muscle relaxants wear off, and gives a drug to help reverse the effect of the NMBDs before the tracheal breathing tube is removed and a patient is awakened and taken to the postoperative care area (PACU).

A patient who receives NMBDs for their routine care can experience a leftover effect of the drug after their general anesthesia wears off. This condition is called Residual Neuromuscular Blockade. The management of NMBDs in patients for routine care vary by anesthesia provider. This study will explore if the use of a specific plan to managing muscle relaxants will help decrease the risk of muscle weakness after general anesthesia. Anesthesiologists routinely use peripheral nerve stimulators to assess the degree of muscle relaxation. Very commonly a series of 4 electrical stimulations are given over 2 seconds and each stimulation result in a twitch of the thumb when the ulnar nerve is stimulated at the wrist. This is called train-of-four (TOF) monitoring. When the patient is deeply relaxed, then all twitches are not present but as the drug effect diminishes over time, the twitches return. When 4 twitches are present, an exact measurement of the so-called TOF ratio can be calculated if an objective monitor is used. The ratio is the strength of the fourth twitch divided by the strength of the first twitch. The most commonly used reversal drug is neostigmine and it is known from previous research that it works more effectively if the muscle relaxation is not profound. In the intervention group, the investigators will confirm that the neuromuscular blockade has spontaneously recovered to a level where all 4 thumb twitches are present before neostigmine is administered.

All patients will have objective measurements obtained using the FDA approved monitor TOF-Watch SX. This monitor will be applied at the beginning of each case and will be calibrated immediately after induction of anesthesia. This is a simple automated process that takes less than 1 minute. The investigators will also obtain a TOF ratio measurement at the beginning of the case, before a muscle relaxant has been administered. This initial measurement allows for normalization of postoperative measurements. Measurement will be obtained again at the time of extubation, i.e. the removal of the breathing tube, which usually occurs in the operating room as the patient is awakened after surgery. Patients are routinely transferred to the post-anesthesia care unit (PACU) within minutes of being extubated and shortly after arrival to the PACU, the anesthesiologists transfers the care to PACU RNs. The investigators will obtain one more TOF-ratio measurement when the patient has just arrived to the post-anesthesia care unit (PACU).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Incidence and Severity of Residual Neuromuscular Blockade With Application of a Protocol for Paralysis and Neostigmine Reversal of Rocuronium
Study Start Date : January 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Paralysis

Arm Intervention/treatment
No Intervention: Controls
Our control group will consist of an observational cohort of 40 patients in whom we will make quantitative assessments of the Train-of-four ratio (TOF ratio). This is done using the TOF-Watch SX monitor. The monitor will be calibrated after induction of general anesthesia, measurement of the TOF ratio will be obtained at time of extubation and again at the time of arrival to the Post Anesthesia Care Unit (PACU).
Intervention
The intervention consists of a protocol for intraoperative management of neuromuscular blockade with rocuronium and reversal with neostigmine. A train-of-four count of 4 at the thumb will be confirmed prior to administration of an adjusted dose of neostigmine. TOF ratio is measured in the same manner as for the Control group, it is done using the TOF-Watch SX monitor. The monitor will be calibrated after induction of general anesthesia, measurement of the TOF ratio will be obtained at time of extubation and again at the time of arrival to the Post Anesthesia Care Unit (PACU).
Procedure: Standardized NMBD Management
The intervention phase will introduce a standardized research protocol that spells out NMBD management, including how muscle relaxant should be administered and monitored, and how reversal with neostigmine should be done.




Primary Outcome Measures :
  1. Incidence of residual paralysis [ Time Frame: The outcome measure will be assessed at time of extubation ]
    The incidence of residual paralysis defined as a TOF ratio <0.9 will be measured.


Secondary Outcome Measures :
  1. Incidence of severe residual paralysis [ Time Frame: The outcome measure will be assessed at time of extubation ]
    The incidence of severe residual paralysis defined as a TOF ratio <0.7 will be measured.



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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:

  • Adults age 18 or older
  • Will undergo open or laparoscopic abdominal surgery expected to last <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 maintenance of neuromuscular block (NMB)

Exclusion Criteria:

  • Allergy to NMBDs
  • Patients with neuromuscular disease (myasthenia gravis or muscular dystrophy)
  • Pregnant or lactating women
  • Non-English speaking
  • Unable to provide informed consent

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): NCT02660398


Locations
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United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Investigators
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Principal Investigator: Stephan Thilen, MD University of Washington

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Stephan Thilen, Assistant Professor, Anesthesiology, University of Washington
ClinicalTrials.gov Identifier: NCT02660398     History of Changes
Other Study ID Numbers: 50608
First Posted: January 21, 2016    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Delayed Emergence from Anesthesia
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