Comparison of Time to Extubation Using Sugammadex or Neostigmine

Sponsor

Temple University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04606901

Collaborator

Merck Sharp & Dohme LLC (Industry)

Enrollment

Location

Arms

26.7

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Neuromuscular Blockade Chronic Obstructive Pulmonary Disease	Drug: neostigmine/glycopyrrolate Drug: sugammadex	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Study groups will be treated equally except for delivery of the neuromuscular blockade reversal medicationStudy groups will be treated equally except for delivery of the neuromuscular blockade reversal medication

Masking:

Double (Participant, Investigator)

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

Primary Purpose:

Treatment

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

Actual Study Start Date :

Apr 8, 2021

Anticipated Primary Completion Date :

Dec 30, 2022

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Sugammadex Patients in this arm of the study will receive Sugammadex as the drug used to reverse neuromuscular blockade.	Drug: sugammadex neuromuscular blockade reversal agent Other Names: Bridion
Active Comparator: Neostigmine/Glycopyrrolate Patients in this arm of the study will receive Neostigmine/Glycopyrrolate as the drugs used to reverse neuromuscular blockade	Drug: neostigmine/glycopyrrolate neuromuscular blockade reversal agents Other Names: prostigmin/robinul

Arm

Intervention/Treatment

Active Comparator: Sugammadex

Patients in this arm of the study will receive Sugammadex as the drug used to reverse neuromuscular blockade.

Drug: sugammadex

neuromuscular blockade reversal agent

Other Names:

Bridion

Active Comparator: Neostigmine/Glycopyrrolate

Patients in this arm of the study will receive Neostigmine/Glycopyrrolate as the drugs used to reverse neuromuscular blockade

Drug: neostigmine/glycopyrrolate

neuromuscular blockade reversal agents

Other Names:

prostigmin/robinul

Outcome Measures

Primary Outcome Measures

number of minutes to return of baseline muscle tone [1-20 minutes]
number of minutes to TOF>0.9 indicating full reversal of neuromuscular blockade agent