A Double-blind, Randomized, Parallel Design Study to Compare Postoperative Recovery Between the Sugammadex Group and the Neostigmine Group in Patients After COVID-19.
Phase: PHASE4
Conditions: General Anesthesia, COVID-19
Sponsor: Korea University Ansan Hospital

 
 
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Prospective Clinical Research Protocol 
 
 
1. Research title, stage, plan identification number, and history of enactment and revision, etc.   
Study Title:  
A double-blind, randomized, parallel design study to compare the recovery after prolonged 
surgery between sugammadex group and neostigmine group in post COVID-19 patients 
Research Phase: Phase 4 
Plan identification number: Protocol No. MIN_MSD_2023  
Revision history: Version 1. 5 
 
 
2. Researcher's affiliation, position, and name 
Principal investigator: Too Jae Min, Professor, Department of Anesthesiology and Pain 
Medicine, Ansan Hospital, Korea University 
Co-investigator: Sangmin Yoon, Medical doctor, Department  of Anesthesiology and Pain 
Medicine, Ansan Hospital, Korea University 
 
 
3. Place and duration of the study 
Conducted by : Korea University Ansan Hospital 
Address:  123, Jeokgeum-ro, Danwon-gu, Ansan-si, Gyeonggi-do 
Period: Medical Research Review Board (IRB) approval date (2023.4.4) – 2024.12.31 
 
 
4. Research necessity and background 
 
Post-COVID-19 conditions are a novel and poorly understood clinical disease with life-
affecting ramifications, and recent studies have shown that patients have worsened their 
autonomic nervous system after COVID-19 and are potentially at risk of autonomic 
dysregulation/autonomic neuropathy. 
Currently, most patients undergoing general anesthesia are using neuromuscular blockers, 
and the residual effect of neuromuscular block delays the recovery of autonomic functions of 
the body after surgery, and causes problems such as deterioration of bladder and bowel 
function after surgery. Therefore, reverse premise is used for postoperative muscle 
relaxation recovery, and clinically, sugammadex and neostigmine have been used a lot. 
Sugammadex generally provides  rapid  recovery,  including recovery from muscle 
relaxation after surgery, compared to neostigmine, but postoperative outcomes have been 
reported with limited coverage in postoperative patients.  Therefore,  in this study, we 

 
 
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expect that  sugammadex  will help restore bowel function and lung function more than 
neostigmine after surgery in patients who have recovered from COVID-19 infection. 
 
 
 
5. Risk/Benefit Analysis 
Currently, most patients undergoing general anesthesia are using neuromuscular blockers, 
and reverse agents are used to restore muscle relaxation after surgery. Clinically 
sugammadex and neostigmine have been widely used (both of which are standard treatments).  
This study compares the results of the two drugs used in clinical trials and there is no 
additional risk from clinical trials, except for general side effects caused by general 
anesthesia. However, there is a risk of personal information exposure, and this will be 
minimized through encryption and access restrictions to protect personal information.   
There is no direct benefit to subjects from the trial, and the information from this study may 
be used to help with future clinical applications. 
 
 
6. Research Objectives 
To compare the effects of sugammadex on postoperative recovery in patients with COVID-19 
infection and regular abdominal surgery within one year of treatment. In particular, we want 
to check the occurrence of dysuria after alcohol. 
 
 
7. Number of target subjects and basis for calculation  
In this study, based on the results of the previous paper reported by Han et al., the target 
number of subjects was calculated as  follows (Jiwon Han, Ah-Young Oh, Yong-Tae Jeon, 
Bon-Wook Koo, Bo Young Kim, Donghyun Kim, Insung Hwang. Quality of Recovery after 
Laparoscopic Cholecystectomy Following Neuromuscular Blockade Reversal with Neostigmine 
or Sugammadex: A Prospective, Randomized, Controlled Trial. J. Clin. Med. 2021, 10, 938. 
https://doi.org/10.3390/ jcm10050938). 
The primary variable was based on the frequency of dysuria (6/38 vs 1/39) and  the number of 
samples was checked using the G*Power program.  The allocation ratio for both patients was 
1, significance 0.05, and power 0. 9, set as awo-tailed test and expected the dropout rate to be 
more than 10%, and calculated the number of test subjects as 112 per group, a total of 224.  
 
 
8. Selection/Exclusion Criteria 
Inclusion criteria 
American anesthesiology physical status I-III patients between the ages of 20 and 70 who are 

 
 
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scheduled to have regular abdominal surgery that is expected to take more than one hour 
and have been diagnosed positive for COVID-19 in the past year and have received oxygen 
therapy. 
Regular surgery is a concept that contrasts with emergency surgery and refers to surgery in 
which sufficient pre-examination and treatment are performed before the start of surgery. 
(ASA I: healthy patients, II: patients with mild illness but no impact on daily life, III: patients 
with illness that affects daily life) 
 
Exclusion criteria 
1. Patients currently infected with COVID-19. 
2. 1 Patients under 9 years of age or over 70 years of age 
3. Patients who are planning to use a heart-lung machine during surgery (e.g., open-heart 
surgery, heart transplantation, lung transplantation, etc.) 
4. Patients who are expected to undergo surgery within one hour or are scheduled to leave 
the hospital within 48 hours after surgery 
5. Those who show active lesions on lung imaging images during preoperative screening or 
who are expected to be difficult to remove intubation immediately because endotracheal 
intubation maintenance is required for postoperative breathing management 
6. Those who are hypersensitive to Benzodiazepines, propofol, r emifentanil, f entanyl citrate, 
rocuronium bromide, sugammadex, flumazenil, and other anesthetics 
7. Those with myasthenia gravis or myasthenia gravis syndrome 
8. Those with cognitive impairment who cannot understand the instructions and consent 
manual of this study 
9. Other cases where the researcher determines that he or she is not suitable for 
participating in this study 
 
Suspension and Elimination Criteria  
If the surgical plan is changed and is not performed, the study will be discontinued and 
dropped. 
 
9. Investigational Drug Information and Management 
Trial drug: Sugammadex is used for the reversal of neuromuscular blockade induced by 
rocuronium or becuronium in patients 2 years of age and older, and  is a colorless 
transparent vial containing a colorless to light yellow transparent solution, and the storage 
method of the drug is as follows.   1) Store at 2~30°C. Do not freeze. 2) Store in its original 
packaging to maintain shading. Vials removed from the packaging can be stored outside for up 
to 5 days. 

 
 
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Treaty: Korean neostigmine methyl sulfate injection (neostigmine) is  used  for the purpose 
of antagonizing the action of non-depolarizing muscle relaxants and is stored in room 
temperature shading in yellow vials containing a colorless transparent solution. 
Management in this study: The drug is routinely applied in actual clinical practice and  is 
stored and administered in accordance with the department policy of the Department of 
Anesthesiology and Pain Medicine along with other anesthetic drugs. 
 
 
 
10. Recruitment method and consent procedure 
10.1 How to recruit candidates 
- Recruitment is performed for patients who are scheduled to undergo general anesthesia for 
surgery. After explaining the contents of the study and the criteria for participation, the 
researcher receives the subject's consent form only for those who voluntarily wish to 
participate in the study. After that, the eligibility for participation in the study is determined 
and this study is carried out on those who are judged eligible through the selection/exclusion 
criteria.  
10.2. How to obtain a consent form  
- The principal investigator and the person in charge of the study shall verbally fully explain 
the contents and risks of the experiment to those who are willing to participate voluntarily 
before the clinical trial, and obtain written consent. 
- The researcher may express his or her intention to drop out at any time and announce that 
there is no penalty. 
- After sufficient explanation and confirmation of the subject's understanding, obtain a 
consent form to participate in the experiment. 
 
 
11. When recruiting vulnerable targets, protection measures 
 Do not recruit vulnerable targets. 
 
 
12.  Screening test items and methods 
This study  does not perform additional screening tests  other than  general anaesthesia 
and general screening for surgical preparation (including basic blood, urine tests and chest 
X-rays). 
 
 
 
 
13. Study design and methods  
1. This study is conducted in patients scheduled for surgery under general anesthesia in a 

 
 
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single-organ, randomized, parallel design, and double-blinded. 
Study subjects who have completed screening tests and voluntarily agreed to participate in 
this study among subjects who meet the inclusion/exclusion criteria will be randomized 1:1 to 
the Sugammadex injection group or the neostigmine injection group (control).  The 
assignment of the two groups is randomized by  computer-generated randomization method  
by a table using www.randomization.com. The expected research flow chart is as follows. 
 
 
 
2. After the patient enters the operating room, the patient is equipped with an 
electrocardiogram, oxygen saturation, esophageal thermometer,  electroencephalography, 
non-invasive blood pressure monitoring device, and  muscle relaxation monitoring equipment 
(TOF equipment). The method of anesthesia is according to the standard anesthesia method 
and is described in detail below. 
 
3.  Preanesthetic treatment: Midazolam 2 mg 
 
4. Anesthesia inducer: Anterior venous anesthesia (propofol 2~1.5 mg/kg)  
 

 
 
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5.  Neuromuscular blockers: Rocuronium 0.6 mg/kg IV in tracheal intubation  , additional 
administration of rocuronium to keep TOF below 2 during surgery, 0.15 mg/kg. 
 
6.  Neuromuscular reversal: TOF  results are checked at the end of surgery and neostigmine 
or sugammadex is administered according to  the instructions. If TOF < 2, postpone 
administration until TOF 2  or higher spontaneously recovers.  When recovering from TOF 2 
or more, a prepared neuromuscular reversal agent is administered. 
Neostigmine 50μg/kg  + glycopyrollate 0.01mg/kg in the Neostigmine group  
Sugammadex 2mg/kg from  Sugammadex group 
Neuromuscular reversal is received and prepared in advance by a separate medical staff (a 
separate anesthesiologist who does not participate in the patient's anaesthesia) using the drug 
and  the corresponding prescription order is made separately at the time  of leaving the  
patient  recovery room.  Since it is  diluted with saline  and prepared in a total of 5 cc, the 
patient and the patient's anesthesiologist  will not know the drug  until they  leave  the 
recovery room (double-blinded). 
After checking the TOF ratio ≥ 0.9, the endotracheal tube is removed.  3If muscle relaxation 
recovery is delayed for more  than 0 minutes, more  than 2 mg / kg  of sugammadex can be 
used regardless of the group, in  which case the administration and dosage should be 
recorded separately. 
 
7.   Postoperative pain control 
In  the postanesthetic recovery room (PACU), 30 mg k etorolac is  administered 
intravenously as a rescue analgesic as  a first-line rescue medication, followed by an 
additional 50 μcg f entanyl (up to 2 doses).  
 In a general hospital room, tramadol  37.5 mg/a cetaminophen 325 mg is administered orally 
three times from the time of drinking water. If bowel function has not yet recovered or pain 
cannot be controlled with oral medications, nalbuphine 10 mg, pethidine 25 mg, and tramadol 
100 mg are administered intravenously in that order. If the patient  has  adverse reactions to 
narcotic analgesics,  100 mg  of ketoprofen or 1 g of propacetamol are  administered. 
 
8.   Management of nausea and vomiting after surgery (PONV) 
Ramosetron 0.3 mg is administered as a first-line antiemetic agent, and if vomiting / nausea 
persists, metoclopramide 10 mg and palonosetron 0.075 mg are administered. 
 
9.   Postoperative urinary retention (POUR) management 
Regardless of whether the patient feels a feeling of urination, if the bladder volume exceeds 
600 ml, it is considered a urinary retention POUR.  A  separate doctor who did not 
participate in intraoperative anesthesia measures  and calculates bladder volume using 
ultrasound with a C onvex probe.   Bladder volume is  routinely assessed one hour  after 

 
 
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arrival at the PACU, and if the patient feels urgency to urinate within one hour of arriving at 
the PACU, further evaluation of bladder volume is performed immediately.   There are no 
additional costs for ultrasound examination. 
 The method of measuring the remaining amount of the bladder is as follows. 
• After placing the ultrasonic probe on the upper part of the pubic bone, measure the widest 
width on the horizontal surface first, and measure the length on the longitudinal side. Finally, 
after measuring the depth from the front and rear sides, calculate the bladder volume with the 
formula (width x depth x length x coefficient (table below  )). 
 
 
If urinary retention is identified, a Foley catheter is inserted into the patient. After placement 
of the Foley catheter, urine discharge is measured and bladder volume  is reassessed. In 
principle,  self-urination is not allowed, but in the case of  autourination,  the bladder 
volume is estimated by  combining  the amount of urination and the amount of residual urine. 
 
10. End-point timeline 
The  occurrence of urinary retention after surgery is measured at 1 hour, 24 hours, and 48 
hours, respectively, based on the arrival time in the postoperative recovery room. 
The first fart time is  measured from the time you arrive in the recovery room after surgery. 
Two days after surgery, chest X-ray imaging is performed to  check for changes in 
radiological aeration such as pneumonia infiltration, lobe, segmental and segmental 
atelectasis. 
 
 
14. Standard treatment method for target disease 
The anaesthesia method used in this review is the standard of care currently common in  all 
patients undergoing general  anaesthesia, and this review does not change the anaesthesia 
method or other medical interventions.   
 
15. Effectiveness evaluation items and methods 
Study endpoints  
 
Primary endpoints 
Whether urinary retention occurs 1 hour after  surgery 
 
Secondary endpoints 
Surgery time and anesthesia time 

 
 
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 Recovery time after anesthesia 
Intraoperative bleeding, vital signs 
 Whether and how to administer additional sugammadex 
Bladder volume assessed at  1 hour  postoperative (summing of autologous urination volumes) 
Recovery score and pain score assessed at 1 hour after surgery 
First fart time 
Whether urinary retention occurs at 24 or 48 hours  after surgery 
Presence of acute lesions on chest x-ray 2 days after surgery 
Actual use of pain and nausea control medications 
Other intraoperative events (such as arousal (open eyes), involuntary movements, adverse 
events and unexpected side effects) 
 
Independent variables 
Patient gender, age, weight, height 
American Academy of Anesthesiology Physical Classification (ASA class) 
Heart rate, blood pressure, oxygen saturation (SpO2), muscle relaxation monitoring score 
(TOF) 
 
 
16. Statistical analysis method 
 
Statistical analysis will be performed using SPSS software. (SPSS version 22.0, IBM 
Corporation, Armonk, NY, USA), 
Continuous variables (variables expressed  as mean ± standard deviations)  will be compared using  an 
independent t-test  or  Mann-Whitney U test, and  categorical variables  (including the presence of urinary 
retention and other adverse events) will be compared using a chi-squared test (or Fisher's exact test).    Data 
are expressed as mean ± standard deviation, median (25; 75 median), or number of patients (%).  If the p-value 
is less than 0.05, it is considered to have statistical significance.  
 
 
17. Criteria  for discontinuation and withdrawal from clinical studies 
1) When the subject withdraws his/her consent to participate in the clinical trial 
2) If the test cannot be continued due to a serious adverse reaction or sudden accident 
3) If the test subject does not or is unable to comply with the visits and procedures specified 
in the plan. 
4) If it is difficult to continue the test due to the manifestation of severe complications 
5) If a test subject who does not meet the selection criteria participates in the test 
6) If the test subject who meets the exclusion criteria participates in the test   
 

 
 
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In the event of dropout, the patient's records are kept confidential and are not used for study 
analysis. The patient is treated with known therapies even after opting out of the trial. 
 
 
18. Evaluation criteria, evaluation methods, and reporting methods of safety including adverse 
events 
Since this study is conducted with standard treatment methods, there is no risk from clinical 
trials except for general side effects caused  by general anesthesia and surgery. 
The test method used in the study is recorded for causality and any adverse events, and the 
severity, severity, duration, and causal relationship with the test method are subsequently 
assessed. Treatment and consequences for adverse reactions are also recorded. Adverse 
reactions are evaluated by abnormal screening or additional tests and examinations as 
necessary, in addition to the planned screening and findings of the test during the test 
period, and immediate action is taken. Frequency, expression rate, list of each, severity, and 
causal relationship with test methods are presented,  If necessary, report in the form of a 
graph.   
1) Severe adverse reactions are classified into mild, severe abnormalities, and severe 
according to the following definition.  Mild is normal, transient, and does not interfere with 
daily activities.  Moderation causes some discomfort or interferes with daily activities.  
Severe illness is inability to perform daily activities.  2) Causality Causation is classified as 
'not thought to be relevant', 'likely to be related', 'highly likely', 'obviously related', or 
'difficult to ascertain relevance'. 
 
 
19. Measures to protect personal information and maintain confidentiality of research data 
The subject's information completely removes the information that can identify the individual,  
and the document containing the inspector's record is stored in a locked place to prevent 
the leakage of information. Even after the end of the study, the subject's identity is 
accessible only to the participating researchers, and the subject's personal information is 
permanently destroyed three years after the end of the experiment. All researchers 
participating in this study are obliged to ensure the confidentiality of the research subjects. 
 
 
20. Management, storage, and disposal measures for the collection of human derivatives,  etc. 
Not applicable. 
 
 
21. Planning description of the statistical analysis of the study, including planning for interim 
analysis and the scope of early termination of the study if necessary 

 
 
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Not applicable. 
 
 
22. Continuous safety monitoring plan and data safety monitoring plan 
Since this study  proceeds with the same setting as the actual clinical  trial, except for the 
contents of blinding and group assignment, the additional risk that may arise  from the study  
is minimal. Nevertheless, the principal investigator and the participating researcher entrusted 
by the principal investigator plan to monitor the safety of data and continuously monitor the 
safety of subjects during the experiment, under the supervision of the principal investigator. 
(1) Monitor personnel 
Only the principal investigator and participating researchers authorized by the principal 
investigator are eligible, and the qualifications of the researchers are limited to those 
registered at Korea University College of Medicine or the Industry-Academia Cooperation 
Group.  The monitor must be able to prove his or her qualifications with resumes, etc., and 
perform his or her duties in accordance with the clinical trial protocol  , standard work 
instructions,  monitoring plan, etc.  The principal investigator is responsible for the 
monitoring and supervision of monitoring and for the quality and reliability of the data 
collected on the trial. 
(2) Continuous safety monitoring plan of the target person 
In a clinical trial in patients undergoing general anesthesia and MAC anesthesia, researchers 
continuously monitor the patient's hemodynamic signs during the general anaesthesia and 
MAC sedation period.  The duration of the double-blind examination is from the selection of 
the patient group  to the primary endpoint 1 hour after surgery to  the exit from the 
recovery room after confirming whether urinary retention occurs, and  then  up to  48 hours 
after surgery to check whether specific complications occur and determine whether the 
complications are relevant to the clinical trial.     Details of the award are as follows:  
(relevant/irrelevant,  start, end, last observation: recovered/recovering/not 
recovering/recovered but with sequelae/death/unknown) 
(3) Data safety monitoring plan 
The principal investigator will check whether it is conducted and recorded in accordance with 
the clinical study protocol, standard work guidelines, clinical study practice standards and 
related regulations during the entire clinical trial cycle, and interim monitoring will be 
conducted in December 2023, final monitoring in December after the end of the trial in 2024, 
and a total of two sessions. Conduct evidence document verification such as  case records,  
supporting documents, and  other clinical trial-related documents for accuracy, completeness, 
and mutual agreement, and if the  monitoring-related work is to be coordinated, risk 
assessment shall be carried out and the application shall be carefully examined according to 
the results. 
(4) Risk assessment 

 
 
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In adjusting and changing the type, scope, period,  and scope of monitoring work, risk 
assessment is carried out and the results are documented.  In this case, the procedure 
prescribed in the standard work manual shall be carried out including the following points. 
1) Characteristics of clinical trial institutions identified through selection evaluation, etc. 
2) Procedures that have a significant impact on the quality, reliability, and completeness of 
clinical trial results; 
fulfilment 
3) Types of clinical trial data collected. 
4) Clinical trial evaluation variables 
5) Matters related to clinical trial design and blindfold maintenance 
6) Characteristics of investigational drugs 
7) In addition, the protection and safety of test subjects, the quality and reliability of clinical 
trial data, etc. 
What's related 
If the risk assessment is not carried out appropriately, the monitoring method, period, scope, 
procedure, etc. shall not be arbitrarily reduced or changed, such as the reduction of visit 
monitoring or the task of checking supporting documents, etc. for the clinical trial conducting 
institution, the test subject, the collected items, etc., and the monitoring method, cycle, scope, 
procedure, etc. according to the  risk assessment result shall be reduced and if matters that 
significantly affect the quality and reliability of the clinical trial results and the safety of the 
test subjects are identified, the method before the reduction,  Monitoring should be carried 
out according to the periodic procedure and scope. 

 
 
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23. Research Implementation Plan (Schedule) 
 
Detailed 
development details 
Detailed Timeline 
2023. 
1. 
2 
3-6 
7-9 
10-
12 
2024
.  1-
3. 
4-6 
7-
8 
9-10 
11-
12. 
Research Plan and 
Medical Research 
Review Committee 
Approval 
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Recruitment and  
Conducting 
Research 
Procedures 
 
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Data analysis and 
result reporting 
 
 
 
 
 
 
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24.  References  
1. 
Post-COVID 
conditions: 
Information 
for 
healthcare 
providers. 
Available 
at. 
https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/postcovid-conditions. .html; 
July 14, 2021Accessed. 
2.   Dani, M., Dirksen, A., Taraborrelli, P., Torocastro, M., Panagopoulos, D., Sutton, R., & 
Lim, P. B. (2021). Autonomic dysfunction in 'long COVID': rationale, physiology and 
management strategies. Clinical medicine (London, England), 21(1), e63–e67. 
3. Shouman K, Vanichkachorn G, Cheshire WP, Suarez MD, Shelly S, Lamotte GJ, Sandroni P, 
Benarroch EE, Berini SE, Cutsforth-Gregory JK, Coon EA, Mauermann ML, Low PA, Singer 
W. Autonomic dysfunction following COVID-19 infection: an early experience. Clin Auton 
Res. 2021 Jun;31(3):385-394. doi: 10.1007/s10286-021-00803-8. Epub 2021 Apr 16.  
4. Bureau, B. L., Obeidat, A., Dhariwal, M. S., & Jha, P. (2020). Peripheral Neuropathy as a 
Complication of SARS-Cov-2. Cureus, 12(11), e11452. 
5.  Xue Y, Wang YY, Zhang K, Cong W, He B, Zeng FC. A Study of Complete Video-Assisted 
Thoracoscopic Surgery Lobectomy in Treatment of Elderly Patients with Non-Small Cell 
Lung Cancer: Curative Effect and Impact on Clinical Prognosis. Cell Biochem Biophys. 
2015;73(2):399-404. 
6.  Blobner M, Eriksson LI, Scholz J, Motsch J, Della Rocca G, Prins ME. Reversal of 
rocuronium-induced neuromuscular blockade with sugammadex compared with neostigmine 

 
 
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during sevoflurane anesthesia: results of a randomized, controlled trial. Eur J Anaesthesiol. 
2010;27(10):874-81. 
7.  Manzo Suzuki, Toshiichiro Inagi, Takehiko Kikutani, Takuya Mishima, Hiroyasu Bito. 
Negative Pressure Pulmonary Edema after Reversing Rocuronium-Induced Neuromuscular 
Blockade by Sugammadex. Anesthesiology Volume 2014, Article ID 135032, 3 pages. 
8.  Gopalaiah Venkatesh Kumar, Anita Pramod Nair, Hanuman Srinivasa Murthy, Koppa 
Ramegowda Jalaja. Residual Neuromuscular Blockade Affects Postoperative Pulmonary 
Function. Anesthesiology 2012; 117:1234-44. 
9. Miller, R.D. Miller’s Anesthesia, 9th ed.; Glopper, M.A., Cohen, N.H., Eriksson, L.I., Fleisher, 
L.A., Leslie, K., Wiener-Kronish, J.P., Eds.; Elsevier: Philadelphia, PA, USA, 2015; Volume 1, 
pp. 846–847. 
10.  Jiwon Han, Ah-Young Oh, Yong-Tae Jeon, Bon-Wook Koo, Bo Young Kim, Donghyun 
Kim, Insung Hwang. Quality of Recovery after Laparoscopic Cholecystectomy Following 
Neuromuscular Blockade Reversal with Neostigmine or Sugammadex: A Prospective, 
Randomized, Controlled Trial. J. Clin. Med. 2021, 10, 938. https://doi.org/10.3390/ 
jcm10050938.