Clinical trial NCT04606901
Conditions: Neuromuscular Blockade Chronic Obstructive Pulmonary Disease
Keywords: Nondepolarizing neuromuscular blockade sugammadex bronchoscopy outpatient lung disease
Sponsor: Temple University
Start date: 2021-04-08; Completion date: 2023-07-30
Enrollment: 58 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

Arms: arm 1: Patients in this arm of the study will receive Sugammadex as the drug used to reverse neuromuscular blockade. arm 2: Patients in this arm of the study will receive Neostigmine/Glycopyrrolate as the drugs used to reverse neuromuscular blockade
Interventions: intervention 1: neostigmine/glycopyrrolate intervention 2: sugammadex
Intervention descriptions: intervention 1: neuromuscular blockade reversal agents intervention 2: neuromuscular blockade reversal agent

Protocol documents:
Prot_SAP_001.pdf: 
Comparison of time to full recovery of muscle paralysis (TOF>0.9) and 
extubation using Sugammadex versus Neostigmine/Glycopyrrolate in 
patients with pulmonary disease in the outpatient Bronchoscopy Suite 
 
 
Page 1 of 13 
     Last Revision: 19-May-2023 
1) Abstract of the study 
Patients who have chronic lung diseases such as chronic obstructive 
pulmonary disease (COPD) and interstitial lung disease (ILD) are known to 
experience more postoperative pulmonary complications (PPC) such as re-
intubation, COPD or ILD exacerbation, pulmonary infection and even 
respiratory failure than those without this diagnosis. Studies have suggested 
that respiratory muscle strength may be a contributing factor to such 
complications. These patients often require outpatient bronchoscopic 
procedures such as lung biopsies, tracheal and bronchial dilations, and 
bronchoalveolar lavage. These procedures are conducted either under 
conscious sedation, or general anesthesia. Our study will focus on lung 
patients in the bronchoscopy suite undergoing procedures requiring general 
anesthesia. Due to these patients’ health status, it is important to ensure 
appropriate neuromuscular reversal and extubation time. We propose the 
following hypotheses to improve the efficiency of patient care in the 
bronchoscopy suite. If Sugammadex is used to reverse neuromuscular 
blockade after outpatient bronchoscopy in patients with COPD or ILD, they 
will recover from the neuromuscular blockade completely and more efficiently 
(faster) than if neostigmine and glycopyrrolate are given for the same 
purpose.  In addition, if Sugammadex is used to reverse neuromuscular 
blockade after outpatient bronchoscopy in patients with COPD or ILD, they 
will be extubated sooner than if neostigmine and glycopyrrolate are given for 
the same purpose. Finally, if Sugammadex is used to reverse neuromuscular 
blockade after outpatient bronchoscopy in patients with COPD or ILD, these 
patients will be discharged from the bronchoscopy suite sooner than if 
neostigmine and glycopyrrolate are given for the same purpose. The latter 
two hypotheses are secondary to the first listed hypothesis. 
 
 
2) Protocol Title 
Comparison of time to full recovery of muscle paralysis (TOF>0.9) and 
extubation using Sugammadex versus Neostigmine/Glycopyrrolate in 
patients with pulmonary disease in the outpatient Bronchoscopy Suite 
3) Sponsor / Funding 
Merck Investigator Studies Program Review Committee approval 
#59676 
 
4) IRB Review History 
None. 
5) Investigator 
 Ellen Hauck DO PhD 
 Professor and Vice Chair for Research 


Comparison of time to full recovery of muscle paralysis (TOF>0.9) and 
extubation using Sugammadex versus Neostigmine/Glycopyrrolate in 
patients with pulmonary disease in the outpatient Bronchoscopy Suite 
 
 
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     Last Revision: 19-May-2023 
 Department of Anesthesiology, LKSOM at Temple University 
 3401 N Broad St 
 Philadelphia, PA 19140 
 267-443-8719/215-707-8028 
 Ellen.hauck@tuhs.temple.edu 
 
6) Objectives 
The objective of this study is to compare time to full reversal of 
neuromuscular blockade between use of Sugammadex or 
neostigmine/glycopyrrolate as determined by train of four >0.9 in patients with 
pulmonary disease in the outpatient bronchoscopy suite. A secondary 
outcome measured will be time to extubation. 
 
7) Background 
Patients with COPD and ILD are more likely to have PPC. Severity of their 
disease and length of the operative procedure both correlate with an increase 
in these complications [1-5]. This patient population has also been shown to 
develop progressive atrophy of their respiratory muscles: thoracic accessory 
muscles in those with COPD and the diaphragm in those with ILD [6,7].  
Studies have shown that pulmonary rehabilitation can reduce dyspnea and 
improve pulmonary function [8], suggesting that respiratory muscle strength is 
a possible factor contributing to adverse events.  In support of this hypothesis, 
one study looking at ASA 3 patients having noncardiac surgery under general 
anesthesia, found that those patients who had a PPC required higher doses 
of neostigmine prior to extubation, although their dose of neuromuscular 
blockade was not different from those who did not have a PPC [9].  It is these 
chronic lung disease patients that come to the bronchoscopy suite for 
outpatient procedures, commonly lung biopsies. While some bronchoscopic 
procedures are performed under conscious sedation (no anesthesiologist, 
midazolam and fentanyl only), many others require general anesthesia with 
endotracheal intubation and neuromuscular blockade.  Given these patients’ 
compromised respiratory muscle strength, it is logical that full and timely 
reversal of neuromuscular blockade is essential to the prompt recovery of 
these patients after bronchoscopy.   
In addition to the respiratory compromise of outpatients for bronchoscopy, 
reliable timely extubation is essential to the efficiency of the bronchoscopy 
suite.  These cases run for highly variable periods of time (20 minutes to 2 
hours) and the neuromuscular blockade should be reversed in an efficient 
manner. Given the need for general anesthesia with neuromuscular blockade 
and the unpredictability of the duration of the bronchoscopic procedure, there 


Comparison of time to full recovery of muscle paralysis (TOF>0.9) and 
extubation using Sugammadex versus Neostigmine/Glycopyrrolate in 
patients with pulmonary disease in the outpatient Bronchoscopy Suite 
 
 
Page 3 of 13 
     Last Revision: 19-May-2023 
is a need for prompt reversal of neuromuscular blockade not dependent on 
the depth of the neuromuscular blockade at the end of the procedure.  
Our proposed study hopes to determine the efficacy of the use of 
Sugammadex as compared to neostigmine and glycopyrrolate to reverse 
neuromuscular blockade with respect to the predictability of both timing and 
completeness of such reversal.  Completeness of reversal will be measured 
using the TwitchView monitor, an electromyography (EMG)-based device to 
detect muscle twitch strength after delivery of electrical stimulus. Patients will 
be randomized to receive one reversal treatment or the other, and the time to 
full reversal of neuromuscular blockade as well as the time to extubation will 
be followed.  
 
7) Setting of the Human Research 
This study will be conducted in the bronchoscopy suite at Temple University 
Hospital, Philadelphia PA. The potential subjects will be recruited during their 
preoperative anesthetic examination in PAT. All investigators and research 
staff will have valid CITI training.  
 
8) Resources Available to Conduct the Human Research 
Merck, Sharp & Dohme, Corp. will provide the following drugs:  
Drug Name: Sugammadex 
Amount:  up to 4mg/kg for 40 patients 
Drug Name: Neostigmine and glycopyrrolate 
Amount: 5mg vial and 0.6mg respectively for 40 patients 
9) Prior Approvals 
Merck Investigator Studies Program Review Committee approval.  
 
10) Study Design 
a) Recruitment Methods 
Patients will be recruited during their Pre-Admission Testing visit on 
the first floor of Temple University Hospital. A member of the 
research team will approach a patient who is scheduled for an 
outpatient bronchoscopic procedure requiring general anesthesia. 
The patient will be given enough time to make an informed decision 
about their participation and will be given a copy of all signed 
consent documents.   
b) Inclusion and Exclusion Criteria 
i) Inclusion: 


Comparison of time to full recovery of muscle paralysis (TOF>0.9) and 
extubation using Sugammadex versus Neostigmine/Glycopyrrolate in 
patients with pulmonary disease in the outpatient Bronchoscopy Suite 
 
 
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     Last Revision: 19-May-2023 
a. Patients older than 18  
b. Have a diagnosis of COPD and/or ILD 
c. ASA 3 or ASA 4 
d. Requiring general anesthesia for a bronchoscopy suite biopsy 
procedure  
e. English speakers 
f. GFR greater than 30 cc/minute 
ii) Exclusion: 
a. Vulnerable populations 
b. Patients undergoing non biopsy procedures 
c. Monitored Anesthesia Care (MAC) procedures 
d. Non-English speakers 
c) Study-Wide Number of Subjects 
80 patients 
d) Study Timelines 
It is expected to take 1 year after approval to enroll a total of 80 subjects. 
With an additional 6 months for data analysis and study closure. A total of 
18 months from approval.  
We also would like to acknowledge the COVID-19 pandemic and will not 
begin enrollment or other study procedures until normal hospital 
procedures are resumed.  
 
11) Procedures Involved in the Human Research 
 
This research study will have the design of a blinded randomized clinical trial.  
The pharmacist will not 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 COPD and/or ILD and who require 
medical treatment for the same. Patients who belong to a vulnerable 
population will be excluded (pregnant women, prisoners, patients with 
dementia or otherwise not able to consent themselves).  Requiring medical 
treatment for these conditions will place the patients in the ASA 3 or ASA 4 
health status category based on their pulmonary disease.  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 


Comparison of time to full recovery of muscle paralysis (TOF>0.9) and 
extubation using Sugammadex versus Neostigmine/Glycopyrrolate in 
patients with pulmonary disease in the outpatient Bronchoscopy Suite 
 
 
Page 5 of 13 
     Last Revision: 19-May-2023 
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.  We plan 
to follow each patient’s depth of neuromuscular blockade using the 
TwitchView monitor, a commercially available, EMG-based monitor.  The 
TwitchView measures muscle response to delivered electrical stimuli (2Hz) 
which are sent in sets of 4 0.5 seconds apart(most commonly). The muscles 
controlled by the ulnar nerve are most commonly followed, and will be during 
this study. These set of electrical stimuli are called a train of four.  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. The device can also deliver one long electrical stimulus of 
50 Hz over 5 seconds which is called a tetanic stimulus.  This causes a large 
release of acetylcholine into the muscle synapses so that the muscle fibers 
are more sensitive to the train of four stimuli and can be used to detect 
weaker muscle strength response. This only occurs if recovery from 
neuromuscular blockade has begun. 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.   The TwitchView 
monitor will deliver a train of four stimulus to the patient every 5 minutes 
during the procedure until full reversal of neuromuscular blockade is detected. 
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.   This means that upon completion of the procedure, 
patients in the Sugammadex arm will be reversible from the point of 1-2 post 
tetanic muscle twitches or better.  Depending on the results from the 
TwitchView monitor, the dose of Sugammadex given will be appropriate for 
the finding of deep (4mg/kg) or moderate block(2mg/kg).   Those in the 
Neostigmine/glycopyrrolate arm will be reversible from the time of detection of 
1-2 twitches. Comparison of the data from the two arms of the study will then 
be made.  
Adverse events will be reported using the adverse event reporting document 
attached.  Adverse events will also be subjected to statistical analysis as 


Comparison of time to full recovery of muscle paralysis (TOF>0.9) and 
extubation using Sugammadex versus Neostigmine/Glycopyrrolate in 
patients with pulmonary disease in the outpatient Bronchoscopy Suite 
 
 
Page 6 of 13 
     Last Revision: 19-May-2023 
described below.  This report is copied from the AE form provided our study team 
for the Merck 8616-145 study. 
 
Determination of deep vs moderate blockade: 
In order to provide neuromuscular blocking reversal medications at the proper time and 
dose, the degree of neuromuscular blockade for each patient must be monitored.  The 
monitor we will use is called the TwitchView monitor.  It will be attached by stickers to 
one hand/thumb of the patient, and every 5 minutes small electrical stimuli will be given 
through the device and the muscle responses or twitches measured by the device.  The 
electrical stimuli are given as four impulses of 50 Hz, 100milliseconds apart.  This set of 
stimuli is called the train of four. The depth of the neuromuscular blockade is measured 
by how many twitches the patient’s muscles have to these stimuli (1,2 ,3 or 4) and how 
strong the 4th twitch is compared to the 1st twitch. A moderate level of neuromuscular 
blockade is defined by the detection of at least two twitches (no ratio needed here). If the 
TwitchView does not register any muscle response to the stimuli, it sends a single 100Hz 
stimulus followed by the standard train of four stimuli.  A deep neuromuscular blockade 
is defined as at most 1 or 2 twitches in response to this set of stimuli.  Full reversal of 
neuromuscular blockade is defined at four twitches with a ratio of at least 0.9 of the 1st 
twitch to the 4th twitch.  
 
Treatment: 
Medication dosing for each arm of the study will be as follows: 
 
Sugammadex arm:  4mg/kg for deep block or 2mg/kg for moderate block given 
intravenously once procedure is complete and reversal criteria are met. 
 
Neostigmine/glycopyrrolate arm: 0.05mg/kg neostigmine up to a maximum dose 
of 5mg and 0.6mg glycopyrrolate once procedure is complete and reversal 
criteria are met. 
 
Study Limitations:  
Limitations of this study are that it will be performed in a single academic medical 
center (not a multi-center study) and that our population is an inner city, lower 
socioeconomic population and results may not be fully generalizable to other 
populations. In addition, we will be limiting our study to a narrow range of 
procedures often done in the bronchoscopy suite in order to have each 
procedure last approximately an hour.  Procedures to be included will be biopsy 
based procedures (some of these are done with ultrasound, some with 
fluoroscopy).  
 
 
a) Data and Specimen Banking 


Comparison of time to full recovery of muscle paralysis (TOF>0.9) and 
extubation using Sugammadex versus Neostigmine/Glycopyrrolate in 
patients with pulmonary disease in the outpatient Bronchoscopy Suite 
 
 
Page 7 of 13 
     Last Revision: 19-May-2023 
This study will not disclose subjects’ Protected Health Information.  HIPAA 
authorization will be obtained from each participating subject.  Patients will be 
informed during the consent process that any data collected from his/her 
chart will be de-identified so that the subject’s identity is protected. See 
attached data sheet for data collection variables.  
 
Data will be de-identified at the time of collection and kept in a password 
protected and encrypted file.  The file will be accessible only to study 
personnel as needed.  The key to the de-identified data will be kept in a 
password protected and encrypted file accessible only to the study’s principal 
investigator.  This key will be destroyed once full data analysis is complete.  
 
De-identified data will be stored and kept in a password protected and 
encrypted file.  This file will be on the U Drive of Dr. Ellen Hauck in room 
B307 of the Department of Anesthesiology office that is locked behind two 
doors.  
 
De-identified data will be available made available to Merck, Sharp & Dohme, 
Corp. and to any future peer-edited journal, or scientific peers requesting data 
for scientific purposes. 
b) Data Management  
 
Sample size and power considerations 
 
We propose two-arm study with 40 subjects per group: group 1) Sugammadex 2 
mg/kg for reversal of moderate neuromuscular blockade or 4 mg/kg for deep 
block and group 2) Neostigmine/glycopyrrolate for reversal of moderate 
neuromuscular blockade. To evaluate statistical power for primary endpoint of 
recovery time to TOF>0.9, the size of detectable standard deviation unit (SDU) 
was calculated. The SDU corresponds to a beta coefficient in a regression model 
when we assume the standard normal deviate (i.e. N(0,1)).  Using the same 
assumptions above, this study will have 83.8% power to detect an SDU of 2/3 
using a two group t-test with a 5% two-sided significance level.  
 
The assumed SDU of 2/3 is considered as a moderate effect size. Based on 
Couto 2019 Current Clinical Pharmacology, the estimated SDU is 1 between 
Sugammadex for moderate blockade (mean 1.68 SD 0.47 minutes) and 
Sugammadex for deep blockade (mean 2.85 SD 1.17). When comparing 
Neostigmine to Sugammadex, the much larger SDU is expected based on 
Hristorska 2018 Anesthesia (recovery time to TOF>0.9 ranging from 8.43 to 16.7 
minutes).  
 
Statistical analysis plan 


Comparison of time to full recovery of muscle paralysis (TOF>0.9) and 
extubation using Sugammadex versus Neostigmine/Glycopyrrolate in 
patients with pulmonary disease in the outpatient Bronchoscopy Suite 
 
 
Page 8 of 13 
     Last Revision: 19-May-2023 
Descriptive analysis. The patient demographic and characteristics will be 
described using counts with percentages for categorical variables and means 
with standard deviations for continuous variables. These descriptive measures 
will be compared between two groups using chi-square tests for categorical 
variables and two sample t-tests for continuous variables, or comparable 
nonparametric tests. 
 
Analysis of primary endpoint. The primary endpoint of recovery time to TOF>0.9 
will be described for each treatment group using the mean and standard 
deviation. These means will be compared between groups using two sample t-
test. If the randomization results in unbalanced treatment groups, the linear 
regression models will be used to test for treatment effects with any potential 
confounding variables. 
 
Analysis of secondary endpoint. The secondary endpoint is time to extubation. 
This endpoint will be compared between groups using logrank test with Kaplan-
Meier estimates. If the randomization results in unbalanced treatment groups, the 
Cox regression models will be used to test for treatment effects with any potential 
confounding variables. 
 
Analysis of adverse event (AE). The counts and percentage of AE will be 
described overall and by treatment arms. The adverse event rates will be 
compared between two groups using Fisher’s Exact test. This report is copied 
from the AE form provided our study team for the Merck 8616-145 study WIRB 
Protocol #20171782 24966. 
 
c) Provisions to Monitor the Data to Ensure the Safety of subjects 
The PI, Dr. Ellen Hauck will be notified immediately about any 
complication during or after the bronchoscopy procedure. The PI will also 
monitor data to ensure no adverse events or to resolve any adverse 
events. 
d) Withdrawal of Subjects 
Enrolled patients will be withdrawn from the research without their consent 
for any of the following reasons: if the surgery is converted to an open 
procedure or has other serious surgical complications as per surgeon, if a 
surgical complication results in the removal of the TwitchView monitoring 
system, or there is an impairment to the anesthesiologist’s or nurse 
anesthetist’s ability to follow protocol.  
The enrolled patient will be able to withdraw prior to induction of 
anesthesia on the day of the procedure. If a patient decides after awaking 
from anesthesia or at any time after his or her surgery to withdraw from 
the study they will be able to do so. If the patient desires their data be 
removed from the study, it will be destroyed and not used in the study.  
 


Comparison of time to full recovery of muscle paralysis (TOF>0.9) and 
extubation using Sugammadex versus Neostigmine/Glycopyrrolate in 
patients with pulmonary disease in the outpatient Bronchoscopy Suite 
 
 
Page 9 of 13 
     Last Revision: 19-May-2023 
12) Risks to Subjects 
 
Sugammadex (also known as Bridion® )  
Muscles are activated by nerves that send signals to them.  Neuromuscular blocking 
drugs bind at the nerve-muscle interaction site and stop the nerve signals from reaching 
the muscles.  When used as part of standard of care treatment, Sugammadex binds to the 
neuromuscular blocking drug and prevents and disrupts binding to the nerve-muscle 
interaction site to the muscle can receive information from the nerves once again. 
 
The following adverse events are noted in FDA label. 
 Allergic reactions that can sometimes be serious or life-threatening.  
These reactions can occur in persons who have not been previously treated with 
sugammadex.  
Symptoms reported in studies or general use of sugammadex have included:  
 
 Rash 
 Hives 
 Redness of the skin 
 Swelling of the tongue and throat that may cause difficulty breathing or 
swallowing 
 Fast heartbeat 
 Low blood pressure 
 Shortness of breath due to muscle cramps of the airways (bronchospasm). 
 Slower-than-expected recovery of muscle movement after surgery or return of 
muscle weakness after surgery  
 
The most common side effects in patients undergoing surgery are:  
 Cough 
  Airway difficulties  
 Unwanted muscle movement or coughing during surgery  
 Change in heart rate or blood pressure due to the operation 
 
Neostigmine  
 
The following side effects by Neostigmine according to FDA label:  
 Low blood pressure  
 Slowed heart rate  
 Increased heart rate  
 Abnormal heart rhythm 
 Difficulty breathing that can sometimes be serious or life threatening  
 Increased mucous in the respiratory system  
 Reduction of oxygen supply to a tissue  
 Difficulty speaking  


Comparison of time to full recovery of muscle paralysis (TOF>0.9) and 
extubation using Sugammadex versus Neostigmine/Glycopyrrolate in 
patients with pulmonary disease in the outpatient Bronchoscopy Suite 
 
 
Page 10 of 13      Last Revision: 19-May-2023 
 Changes in the ability to see  
 Headache  
 Dizziness  
· Fainting  
 Inability to sleep  
 Dry mouth or increased saliva  
 Nausea and vomiting after the procedure  
 Joint pain  
 Itchiness, rash or redness  
 Pain at the site of surgery; pain in the throat  
 Muscle cramps or spasms  
 Slower than expected recovery of muscle movement after surgery (your 
muscles may stay relaxed longer)  
 Loss of bladder control  
 Increased urine frequency  
 Increased gas and increased bodily functions  
 Abnormal heart rhythms or increase or slowing of the heart rate that can 
sometimes be serious or life-threatening  
 Wheezing or contraction of the muscles of the airway (bronchospasm). This 
may be worse if you have asthma.  
 Difficulty breathing or swallowing 
 Convulsions 
 Drowsiness 
 Difficulty in speech 
 Involuntary muscle twitches 
 Loss of consciousness 
 Blurred vision, and changes in vision. 
  
Glycopyrrolate  
Side effects of glycopyrrolate from FDA label may include:  
 Abnormal heart rhythms, slow or fast heart rate and palpitations that can 
sometimes be serious or life threatening  
 Nausea, vomiting, bloated feeling  
 Constipation  
 Difficulty urinating  
 Difficulty breathing that can sometimes be severe or life threatening 
 Blurry vision, large pupils, eye discomfort in bright light 
 Dry mouth and skin  
 Increased body temperature that can sometimes be serious or life threatening  
 Headache  
 Mental confusion  
 Feeling nervous or restless  


Comparison of time to full recovery of muscle paralysis (TOF>0.9) and 
extubation using Sugammadex versus Neostigmine/Glycopyrrolate in 
patients with pulmonary disease in the outpatient Bronchoscopy Suite 
 
 
Page 11 of 13      Last Revision: 19-May-2023 
 Inability to sleep  
 Dizziness  
 Feeling drowsy  
· Muscle weakness  
 Increased pressure in the eye (glaucoma) 
 Loss of sense of taste  
 Impotence (erectile dysfunction)  
 Hives, itching  
 Decreased sweating  
 Seizures  
 Low or high blood pressure 
 
13) Potential Benefits to Subjects 
There is no direct benefit to subjects participating in the study. 
Information learned from this study could potentially help future 
patients. 
14) Privacy and Confidentiality 
The study will not use or disclose subjects’ Protected Health Information (PHI). 
Appropriate steps will be taken to secure the data including CITI training of involved 
personnel, authorization of access, password protection, encryption, physical 
Certificates of Confidentiality, and separation of identifiers and data. During the 
intraoperative periods medication requirements, vital signs, operative time, and train-
of-four information will be collected. During the recruitment process and on the 
morning of the procedure, subjects will be assured of the privacy of data collected 
and the expertise of their anesthesia team. 
 
15)  for Research-Related Injury 
There is no compensation for research-related injury. If there are 
any complications or injuries patient will be referred to a specialist 
as appropriate. 
16) Economic Burden to Subjects 
There will be no cost of the study drugs billed to the subject.  
17) Subject Compensation 
Subjects will receive a $50 gift card for each visit for a total of $100.  
 
18) Consent Process 
 
Procedures recommended in the “INVESTIGATOR GUIDANCE: Informed 
Consent (HRP-802) document will be followed when obtaining informed consent. 
Patients listed for outpatient bronchoscopy biopsy procedure that requires 


Comparison of time to full recovery of muscle paralysis (TOF>0.9) and 
extubation using Sugammadex versus Neostigmine/Glycopyrrolate in 
patients with pulmonary disease in the outpatient Bronchoscopy Suite 
 
 
Page 12 of 13      Last Revision: 19-May-2023 
general anesthesia with neuromuscular blockade will be approached and 
consented during their preoperative anesthetic evaluation in PAT or in their 
hospital rooms if they are inpatients, at least one day before their day of surgery. 
Only study personnel will obtain consent. Assurances will be given that 
withdrawal from the study at any time is possible, and that all data will be de-
identified. Patients will also sign a HRP 505 in English HIPAA authorization form. 
Non-English Speaking Subjects 
Non-English will not be recruited for this study.  
19) Process to Document Consent in Writing 
We will follow  “INVESTIGATOR GUIDANCE: Documentation of 
Informed Consent (HRP-803).” As well, we will have an additional 
document “Informed Consent Process Documentation”, requiring the 
staff obtaining consent and PI to sign and confirm the subject signed 
the IRB approved consent form and understood what he/she signed. 
This document is also attached.  
 
20) Vulnerable Populations 
The following populations will not be approached to be part of this 
study: Pregnant Women, Neonates of Uncertain Viability, 
Nonviable Neonates, Prisoners, Children, Wards, Adults 
Lacking Capacity  
21) Sharing of Results or Incidental Findings with Subjects 
If patients would like to see the data collected during his or her 
surgery, it will be provided to them. In addition, results from the 
study will also be made available to interested patients.  
 
22) References 
 
1. 
Kreider ME, Hansen-Flaschen J, Ahmad NN, et al. Complications of 
video-assisted thoracoscopic lung biopsy in patients with interstitial lung disease. 
Ann Thorac Surg 2007; 83: 1140-4. 
2. 
Bellinger CR, Khan I, Chatterjee AB, Haponik EF. Bronchoscopy Safety in 
Patients With Chronic Obstructive Lung Disease. J Bronchology Interv Pulmonol 
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3. 
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