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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04606901
Enrollment
58
Registered
2020-10-28
Start date
2021-04-08
Completion date
2023-07-30
Last updated
2024-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease, Neuromuscular Blockade

Keywords

Nondepolarizing neuromuscular blockade, sugammadex, bronchoscopy, outpatient, lung disease

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.

Interventions

neuromuscular blockade reversal agents

DRUGsugammadex

neuromuscular blockade reversal agent

Sponsors

Merck Sharp & Dohme LLC
CollaboratorINDUSTRY
Temple University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Minutes to Return of Baseline Muscle Tone1-20 minutesnumber of minutes from reversal dose to Train of Four (TOF) \>0.9 indicating full reversal of neuromuscular blockade agent

Secondary

MeasureTime frameDescription
Number of Minutes to Extubation1-30 minutesnumber of minutes from Train of Four (TOF) \>0.9 to extubation of the patient

Countries

United States

Participant flow

Participants by arm

ArmCount
Sugammadex
Patients in this arm of the study will receive Sugammadex as the drug used to reverse neuromuscular blockade. sugammadex: neuromuscular blockade reversal agent
28
Neostigmine/Glycopyrrolate
Patients in this arm of the study will receive Neostigmine/Glycopyrrolate as the drugs used to reverse neuromuscular blockade neostigmine/glycopyrrolate: neuromuscular blockade reversal agents
30
Total58

Baseline characteristics

CharacteristicNeostigmine/GlycopyrrolateTotalSugammadex
Age, Continuous65.0 years
STANDARD_DEVIATION 8.8
65.8 years
STANDARD_DEVIATION 8.7
66.6 years
STANDARD_DEVIATION 8.7
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
2 Participants2 Participants0 Participants
Race (NIH/OMB)
Black or African American
7 Participants18 Participants11 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants2 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants2 Participants1 Participants
Race (NIH/OMB)
White
19 Participants34 Participants15 Participants
Sex: Female, Male
Female
7 Participants17 Participants10 Participants
Sex: Female, Male
Male
23 Participants41 Participants18 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 280 / 30
other
Total, other adverse events
0 / 280 / 30
serious
Total, serious adverse events
0 / 280 / 30

Outcome results

Primary

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

Time frame: 1-20 minutes

ArmMeasureValue (MEAN)Dispersion
SugammadexNumber of Minutes to Return of Baseline Muscle Tone3.9 minutesStandard Deviation 2
Neostigmine/GlycopyrrolateNumber of Minutes to Return of Baseline Muscle Tone12.9 minutesStandard Deviation 9.8
Secondary

Number of Minutes to Extubation

number of minutes from Train of Four (TOF) \>0.9 to extubation of the patient

Time frame: 1-30 minutes

ArmMeasureValue (MEAN)Dispersion
SugammadexNumber of Minutes to Extubation11.9 minutesStandard Deviation 8.3
Neostigmine/GlycopyrrolateNumber of Minutes to Extubation17.7 minutesStandard Deviation 10.5

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026