Comparison of Time to Extubation Using Sugammadex or Neostigmine
Primary Purpose
Neuromuscular Blockade, Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
neostigmine/glycopyrrolate
sugammadex
Sponsored by
About this trial
This is an interventional treatment trial for Neuromuscular Blockade focused on measuring Nondepolarizing neuromuscular blockade, sugammadex, bronchoscopy, outpatient, lung disease
Eligibility Criteria
Inclusion Criteria:
- has diagnosis of COPD or ILD
- ASA 3 or 4
- procedure requires general anesthesia in the outpatient bronchoscopy suite
- glomerular filtration rate > 30 ml/min
Exclusion Criteria:
- pregnant women
- prisoners
- those unable to consent for themselves
- procedures not requiring general anesthesia
- ASA 1 or 2
Sites / Locations
- Temple University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Sugammadex
Neostigmine/Glycopyrrolate
Arm Description
Patients in this arm of the study will receive Sugammadex as the drug used to reverse neuromuscular blockade.
Patients in this arm of the study will receive Neostigmine/Glycopyrrolate as the drugs used to reverse neuromuscular blockade
Outcomes
Primary Outcome Measures
number of minutes to return of baseline muscle tone
number of minutes to TOF>0.9 indicating full reversal of neuromuscular blockade agent
Secondary Outcome Measures
number of minutes to extubation
number of minutes from TOF>0.9 to extubation of the patient
Full Information
NCT ID
NCT04606901
First Posted
October 13, 2020
Last Updated
August 23, 2023
Sponsor
Temple University
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT04606901
Brief Title
Comparison of Time to Extubation Using Sugammadex or Neostigmine
Official Title
Comparison of Time to Full Recovery From Muscle Paralysis (TOF>0.9) and Extubation Using Sugammadex Versus Neostigmine/Glycopyrrolate in Patients With Pulmonary Disease in the Outpatient Bronchoscopy Suite
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
April 8, 2021 (Actual)
Primary Completion Date
July 30, 2023 (Actual)
Study Completion Date
July 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Temple University
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
A prospective blinded randomized clinical trial to compare time to extubation using Sugammadex versus Neostigmine/glycopyrrolate as reversal agents after use of neuromuscular blockade agents in an outpatient bronchoscopy suite.
Detailed Description
This research study will have the design of a blinded randomized clinical trial. The pharmacist will be blinded to the study medication given. The anesthesia provider cannot be blinded because he/she will need to determine the proper dose and timing of the neuromuscular blocker reversal medication (the study medications) given at the end of the procedure. The study will recruit 80 patients coming to Temple University Hospital for an outpatient bronchoscopy biopsy procedure that requires general anesthesia with neuromuscular blockade. Rocuronium will be the neuromuscular blockade medication given in this study. Inclusion criteria for these patients will include those age >18 who have a diagnosis of chronic obstructive pulmonary disease (COPD) and/or idiopathic lung disease (ILD) and who require medical treatment for the same; these patients will have American society of anesthesiology physical status (ASA PS) 3-4 based on their pulmonary disease alone.The patients will then be randomly assigned to one of two study arms (40 per arm). Patients in one arm of the study will receive Sugammadex and patients in the other arm will receive neostigmine/glycopyrrolate for reversal of neuromuscular blockade. Due to the nature of bronchoscopy for biopsy, the depth of anesthesia at the end of the case will be difficult to predict; the length of the cases may vary some (although most will be approximately one hour), and patients' metabolism of neuromuscular blocking agents is very much dependent on their personal medication regimens and liver function. Each patient's depth of neuromuscular blockade will be followed using the TwitchView monitor, a commercially available, an electromyography (EMG) based monitor. The TwitchView measures muscle response to delivered electrical stimuli (2Hz) which are sent in sets of 4X0.5 seconds apart (most commonly). The muscles controlled by the ulnar nerve will be followed during this study. Return of muscle strength after reversal agents are given is considered complete when the ratio of the strength of the response to the fourth electrical stimulus to the first stimulus is 0.9. Multiple time points will be recorded, including train of four measurement (TOF) every 5 minutes during the procedure, time and TOF at the end of the procedure, time of reversal medication dosing, time of TOF>0.9 and time of extubation. Reversal medication will be given as soon as each patient's procedure is complete and the patient meets appropriate criteria for reversal for each respective medication. Comparison of the data from the two arms of the study will then be made.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuromuscular Blockade, Chronic Obstructive Pulmonary Disease
Keywords
Nondepolarizing neuromuscular blockade, sugammadex, bronchoscopy, outpatient, lung disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Study groups will be treated equally except for delivery of the neuromuscular blockade reversal medication
Masking
ParticipantInvestigator
Masking Description
Medications will be provided by Merck, Sharp & Dohme Corp and will be delivered to the inpatient pharmacy in such a way as to blind the pharmacist. Patients will also not know which medication they are receiving
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sugammadex
Arm Type
Active Comparator
Arm Description
Patients in this arm of the study will receive Sugammadex as the drug used to reverse neuromuscular blockade.
Arm Title
Neostigmine/Glycopyrrolate
Arm Type
Active Comparator
Arm Description
Patients in this arm of the study will receive Neostigmine/Glycopyrrolate as the drugs used to reverse neuromuscular blockade
Intervention Type
Drug
Intervention Name(s)
neostigmine/glycopyrrolate
Other Intervention Name(s)
prostigmin/robinul
Intervention Description
neuromuscular blockade reversal agents
Intervention Type
Drug
Intervention Name(s)
sugammadex
Other Intervention Name(s)
Bridion
Intervention Description
neuromuscular blockade reversal agent
Primary Outcome Measure Information:
Title
number of minutes to return of baseline muscle tone
Description
number of minutes to TOF>0.9 indicating full reversal of neuromuscular blockade agent
Time Frame
1-20 minutes
Secondary Outcome Measure Information:
Title
number of minutes to extubation
Description
number of minutes from TOF>0.9 to extubation of the patient
Time Frame
1-30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
has diagnosis of COPD or ILD
ASA 3 or 4
procedure requires general anesthesia in the outpatient bronchoscopy suite
glomerular filtration rate > 30 ml/min
Exclusion Criteria:
pregnant women
prisoners
those unable to consent for themselves
procedures not requiring general anesthesia
ASA 1 or 2
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen Hauck, DO PhD
Organizational Affiliation
Lewis Katz School of Medicine at Temple University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Only deidentified data from the study will be made available to other researchers
Learn more about this trial
Comparison of Time to Extubation Using Sugammadex or Neostigmine
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