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Best Practice Using Rocuronium and Reversal With Neostigmine or Sugammadex

Primary Purpose

Muscle Weakness

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Protocol for rocuronium neuromuscular block
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Muscle Weakness focused on measuring neostigmine, sugammadex, rocuronium, neuromuscular blocking agents

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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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Sites / Locations

  • University of Washington Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Subjects undergoing orthopedic or abdominal surgery

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
May 21, 2018
Last Updated
October 14, 2022
Sponsor
University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT03543826
Brief Title
Best Practice Using Rocuronium and Reversal With Neostigmine or Sugammadex
Official Title
Best Practice With Rocuronium, Neostigmine, Sugammadex, and Subjective Monitoring.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
May 21, 2018 (Actual)
Primary Completion Date
November 26, 2018 (Actual)
Study Completion Date
November 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Weakness
Keywords
neostigmine, sugammadex, rocuronium, neuromuscular blocking agents

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
201 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Subjects undergoing orthopedic or abdominal surgery
Arm Type
Other
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Protocol for rocuronium neuromuscular block
Intervention Description
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 Measure Information:
Title
Incidence of Postoperative Residual Neuromuscular Blockade at Time of Arrival to the Post-anesthesia Care Unit.
Description
Postoperative residual neuromuscular blockade is measured by a Train-of-four ratio <0.9 as measured by acceleromyography.
Time Frame
Within five minutes of arrival to the post-anesthesia care unit.
Secondary Outcome Measure Information:
Title
Incidence of Postoperative Severe Residual Neuromuscular Blockade at Time of Arrival to the Post-anesthesia Care Unit.
Description
Postoperative severe residual neuromuscular blockade is measured by a Train-of-four ratio <0.7 as measured by acceleromyography.
Time Frame
Within five minutes of arrival to the post-anesthesia care unit.
Title
Incidence of Postoperative Residual Neuromuscular Blockade at Time of Tracheal Extubation.
Description
Postoperative residual neuromuscular blockade is measured by a Train-of-four ratio <0.9 as measured by acceleromyography.
Time Frame
Within two minutes of time of extubation.
Title
Incidence of Postoperative Severe Residual Neuromuscular Blockade at Time of Tracheal Extubation
Description
Postoperative severe residual neuromuscular blockade is measured by a Train-of-four ratio <0.7 as measured by acceleromyography.
Time Frame
Within two minutes of time of extubation.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan R Thilen, MD, MS
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Best Practice Using Rocuronium and Reversal With Neostigmine or Sugammadex

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