Comparison of Time to Extubation Using Sugammadex or Neostigmine

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease; Neuromuscular Blockade
• Intervention / Treatment: Drug: sugammadex; Drug: neostigmine/glycopyrrolate

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 Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. has diagnosis of COPD or ILD
2. ASA 3 or 4
3. procedure requires general anesthesia in the outpatient bronchoscopy suite
4. glomerular filtration rate > 30 ml/min

Exclusion Criteria:

1. pregnant women
2. prisoners
3. those unable to consent for themselves
4. procedures not requiring general anesthesia
5. ASA 1 or 2

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Minutes to Return of Baseline Muscle Tone	number of minutes from reversal dose to Train of Four (TOF) >0.9 indicating full reversal of neuromuscular blockade agent	1-20 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Minutes to Extubation	number of minutes from Train of Four (TOF) >0.9 to extubation of the patient	1-30 minutes

Collaborators and Investigators

• Sponsor: Temple University
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Ellen Hauck, DO PhD, Lewis Katz School of Medicine at Temple University

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2021
• Primary Completion (Actual): July 30, 2023
• Study Completion (Actual): July 30, 2023

Study Registration Dates

• First Submitted: October 13, 2020
• First Submitted That Met QC Criteria: October 22, 2020
• First Posted (Actual): October 28, 2020

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: bronchoscopy; outpatient; lung disease; sugammadex; Nondepolarizing neuromuscular blockade
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Chronic Disease; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Enzyme Inhibitors; Adjuvants, Anesthesia; Cholinesterase Inhibitors; Parasympathomimetics; Glycopyrrolate; Neostigmine
• Other Study ID Numbers: 26881

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only deidentified data from the study will be made available to other researchers

Drug and device information, study documents

• 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