General AnesthesiaPhase 4NCT05817019
Postoperative Sugammadex After COVID-19
A Phase 4 study testing Sugammadex Sodium and neostigmine 50µg/kg + glycopyrollate 0.01mg/kg in people with General Anesthesia and COVID-19, run by Korea University Ansan Hospital.
Trial summary
Researcher want to compare and evaluate the effect of sugammadex on postoperative recovery, with a focus on the occurrence of postoperative urinary dysfunction, in patients who have undergone regular abdominal surgery within a year of being infected with and treated for COVID-19. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- General Anesthesia, COVID-19
- What is being tested?
- Sugammadex Sodium and neostigmine 50µg/kg + glycopyrollate 0.01mg/kg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2023to 31 Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages between 19 and 70 Male and Female All ethnicity Patients who are scheduled to take non-emergency abdominal surgery under general anesthesia.
- Patients who had the diagnosis of covid-19 by PCR, hospitalized, and applied O2 supplement therapy.
- ASA classification ≤ 3 Patients who had Covid-19 PCR positive within 1 year Patients who had hospitalized by Covid-19, followed by O2 therapy (nasal prong, continuous positive airway pressure (CPAP), ventilator etc.) Patients who hospitalized more than 48 hours after surgery. Patients who had a surgery for more than 1 hour.
Who cannot join
- Not meeting inclusion criteria Declined to participate Active Covid-19 patients with PCR positive. Patients are under 19 or over 70 years old
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Double-blind, Randomized, Parallel Design Study to Compare Postoperative Recovery Between the Sugammadex Group and the Neostigmine Group in Patients After COVID-19.
Researcher want to compare and evaluate the effect of sugammadex on postoperative recovery, with a focus on the occurrence of postoperative urinary dysfunction, in patients who have undergone regular abdominal surgery within a year of being infected with and treated for COVID-19.
Post COVID-19 condition is a new and poorly understood clinical syndrome with potentially significant and life-altering consequences. Recent studies suggest that patients who have recovered from COVID-19 may experience autonomic dysfunction and be at risk for autonomic dysregulation/syndrome. In most patients undergoing general anesthesia, neuromuscular blockers are used, and their residual effects delay the recovery of autonomic function after surgery, leading to problems such as worsening bladder and bowel function. Therefore, reversal agents are used to aid in postoperative muscle recovery, with sugammadex and neostigmine being commonly used in clinical practice. While sugammadex is generally expected to result in faster postoperative recovery, limited reports exist on its effectiveness in patients who have recovered from COVID-19. This study aims to verify whether sugammadex is more effective than neostigmine in aiding the recovery of bowel and pulmonary function after surgery in patients who have recovered from COVID-19.
Read the detailed description
The COVID-19 has had a huge impact on the world, infected tens of millions and killed hundreds of thousands, and has become a threat to humanity's medical defense system. COVID-19 was understood as an acute infection among infections, and it was expected that there would be little or no other risk if the acute symptoms were treated. Contrary to our expectations, however, patients with a history of infection with the coronavirus have reported patients with sequelae lasting for more than several months. The symptoms shown by these patients were not limited to some tissues and organs, but were distributed in various ways throughout our body. These symptoms were defined as 'long COVID'. In particular, among the symptoms of long COVID patients, there were patients who were diagnosed with orthostatic hypotension, vasovagal syncope, and orthostatic tachycardia syndrome from symptoms such as palpitations, shortness of breath, and chest pain. What these diseases have in common is that they are autonomic nervous system diseases. Therefore, it can be assumed that long COVID patients have damage to the function of the autonomic nervous system due to past infections, and many studies have been conducted on this.
The main components of general anesthesia are known to be unconsciousness, muscle relaxation, analgesia, and reflex suppression. Among these, the reasons why muscle relaxation is necessary in general anesthesia include ease of intubation and suppression of unnecessary patient movements during surgery to create a suitable environment for surgery. For muscle relaxation, anesthesiologists administer neuromuscular relaxants, mainly non-depolarizing muscle relaxants. Neuromuscular relaxants have the role of inhibiting neurotransmission by acting on the motor nerve endings of skeletal muscles, because they act on nicotinic cholinergic receptors in motor nerve endings. However, neuromuscular relaxants also act on muscarinic cholinergic receptors to inhibit neurotransmission. Since these muscarinic cholinergic receptors are distributed in the parasympathetic nerves of the autonomic nervous system, neuromuscular relaxants also inhibit the autonomic nerve system controlled by the parasympathetic nerves.
Since neuromuscular relaxants are eliminated from the body by pharmacokinetics, the function of the autonomic nervous system, which has been suppressed by using neuromuscular relaxants, gradually recovers over time. However, if the action of a neuromuscular relaxant remains after surgery, the patient will experience autonomic dysfunction even after surgery, which causes considerable discomfort to the patient. Among them, the symptoms of autonomic dysfunction related to the parasympathetic nerve that patients mainly feel are related to the bladder and bowel. Therefore, after the surgery, the anesthesiologist performs the process of reversing the action of the neuromuscular relaxant when ending general anesthesia, which makes it possible to expect the recovery of the patient's autonomic nervous system function.
There are two main mechanisms of the drugs used for reversal of nondepolarizing neuromuscular relaxants. First, there is a drug that inhibits the action of the neuromuscular relaxant by directly attaching to the neuromuscular relaxant, and second, there is a drug that competitively inhibits the neuromuscular relaxant by increasing the amount of ach in the neuromuscular junction. In the meantime, many studies have shown that a drug with the former mechanism (sugammadex) is superior to the latter drug (typically neostigmine) in the recovery of patients after surgery. However, there is a lack of research on whether the same research results will be shown in long COVID patients who have caused damage to the autonomic nervous system.
Therefore, in this study, sugammadex and neostigmine as described above are divided and administered to approximately 300 long COVID patients in a double-blind manner, and the degree of urinary retention is compared to prove that sugammadex is superior to neostigmine in postoperative recovery even for long COVID patients.
- Conditions
- General Anesthesia, COVID-19
- Being tested
- Sugammadex Sodium, neostigmine 50µg/kg + glycopyrollate 0.01mg/kg
- Keywords
- COVID-19, Postoperative Complications
- Medical subject headings
- COVID-19, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sugammadex SodiumDrug
Also called Bridion
Sugammadex Sodium 2mg/kg when TOF >= 2, postoperative period
neostigmine 50µg/kg + glycopyrollate 0.01mg/kgDrug
Also called neostigmine
neostigmine 50µg/kg + glycopyrollate 0.01mg/kg when TOF >= 2, postoperative period
| Study group | Role | What they receive |
|---|---|---|
| Sugammadex | Experimental | sugammadex 2mg/kg Receives: Drug: Sugammadex Sodium |
| Neostigmine | Active comparator | neostigmine 50µg/kg + glycopyrollate 0.01mg/kg Receives: Drug: neostigmine 50µg/kg + glycopyrollate 0.01mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
urinary retention incidence
urinary retention incidence
Measured: postoperative 1 hour
Secondary outcomes (12)
surgery time and anesthesia time
surgery time and anesthesia time
Measured: perioperative period
recovery time after anesthesia
recovery time after anesthesia
Measured: postoperative period, within 1 hour
intraoperative blood loss
estimated blood loss
Measured: perioperative period
perioperative vital signs
serial follow up during surgery and postoperative recovery room
Measured: perioperative period
additional sugammadex administration
incidence and dosage
Measured: postoperative period, within 1 hour
bladder volume evaluated
Sono-calculated (summation of self-voiding volume during self-voiding)
Measured: postoperative 1 hour
recovery score
postoperative recovery score at PACU
Measured: postoperative 1 hour
pain score
NRS
Measured: postoperative 1 hour
urinary retention
presence of complication
Measured: postoperative 24 and 48 hour
acute lesion on chest X-ray
presence of complication
Measured: 2 days after surgery
actual dosage of drugs for pain and nausea control
pain (ketorolac, fentanyl, tramadol, acetaminophen, nalbuphine, pethidcine, ketoprofen, propacetamol) nausea(ramosetron, metoclopramide, palonosetron)
Measured: postoperative period, within 1 hour
other intraoperative events (awakening (eye opening), involuntary movement, occurrence of adverse events and unexpected side effects, etc.)
presence of complication
Measured: perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start20 Apr 2023 (estimated)
- Primary completion25 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A double-blind, randomized, parallel design study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Ansan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min, Too Jae, Korea University Ansan Hospital
- Investigators
- Too Jae Min, M.D., Ph.D., Study chair, Korea University Ansan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05817019
- Sponsor's protocol ID
- 2023AS0079
- Status last verified
- Apr 2023
- First submitted
- 11 Apr 2023
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Parallel Design Study to Compare Postoperative Recovery Between the Sugammadex Group and the Neostigmine Group in Patients After COVID-19.
- ClinicalTrials.gov ID
- NCT05817019
- Acronym / sponsor ID
- 2023AS0079
- Conditions
- General Anesthesia, COVID-19
- Keywords
- COVID-19, Postoperative Complications
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Korea University Ansan HospitalUniversity, hospital or other
- Study start
- 20 Apr 2023 (estimated)
- Primary completion
- 25 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Researcher want to compare and evaluate the effect of sugammadex on postoperative recovery, with a focus on the occurrence of postoperative urinary dysfunction, in patients who have undergone regular abdominal surgery within a year of being infected with and treated for COVID-19.
Post COVID-19 condition is a new and poorly understood clinical syndrome with potentially significant and life-altering consequences. Recent studies suggest that patients who have recovered from COVID-19 may experience autonomic dysfunction and be at risk for autonomic dysregulation/syndrome. In most patients undergoing general anesthesia, neuromuscular blockers are used, and their residual effects delay the recovery of autonomic function after surgery, leading to problems such as worsening bladder and bowel function. Therefore, reversal agents are used to aid in postoperative muscle recovery, with sugammadex and neostigmine being commonly used in clinical practice. While sugammadex is generally expected to result in faster postoperative recovery, limited reports exist on its effectiveness in patients who have recovered from COVID-19. This study aims to verify whether sugammadex is more effective than neostigmine in aiding the recovery of bowel and pulmonary function after surgery in patients who have recovered from COVID-19.
Detailed description
The COVID-19 has had a huge impact on the world, infected tens of millions and killed hundreds of thousands, and has become a threat to humanity's medical defense system. COVID-19 was understood as an acute infection among infections, and it was expected that there would be little or no other risk if the acute symptoms were treated. Contrary to our expectations, however, patients with a history of infection with the coronavirus have reported patients with sequelae lasting for more than several months. The symptoms shown by these patients were not limited to some tissues and organs, but were distributed in various ways throughout our body. These symptoms were defined as 'long COVID'. In particular, among the symptoms of long COVID patients, there were patients who were diagnosed with orthostatic hypotension, vasovagal syncope, and orthostatic tachycardia syndrome from symptoms such as palpitations, shortness of breath, and chest pain. What these diseases have in common is that they are autonomic nervous system diseases. Therefore, it can be assumed that long COVID patients have damage to the function of the autonomic nervous system due to past infections, and many studies have been conducted on this.
The main components of general anesthesia are known to be unconsciousness, muscle relaxation, analgesia, and reflex suppression. Among these, the reasons why muscle relaxation is necessary in general anesthesia include ease of intubation and suppression of unnecessary patient movements during surgery to create a suitable environment for surgery. For muscle relaxation, anesthesiologists administer neuromuscular relaxants, mainly non-depolarizing muscle relaxants. Neuromuscular relaxants have the role of inhibiting neurotransmission by acting on the motor nerve endings of skeletal muscles, because they act on nicotinic cholinergic receptors in motor nerve endings. However, neuromuscular relaxants also act on muscarinic cholinergic receptors to inhibit neurotransmission. Since these muscarinic cholinergic receptors are distributed in the parasympathetic nerves of the autonomic nervous system, neuromuscular relaxants also inhibit the autonomic nerve system controlled by the parasympathetic nerves.
Since neuromuscular relaxants are eliminated from the body by pharmacokinetics, the function of the autonomic nervous system, which has been suppressed by using neuromuscular relaxants, gradually recovers over time. However, if the action of a neuromuscular relaxant remains after surgery, the patient will experience autonomic dysfunction even after surgery, which causes considerable discomfort to the patient. Among them, the symptoms of autonomic dysfunction related to the parasympathetic nerve that patients mainly feel are related to the bladder and bowel. Therefore, after the surgery, the anesthesiologist performs the process of reversing the action of the neuromuscular relaxant when ending general anesthesia, which makes it possible to expect the recovery of the patient's autonomic nervous system function.
There are two main mechanisms of the drugs used for reversal of nondepolarizing neuromuscular relaxants. First, there is a drug that inhibits the action of the neuromuscular relaxant by directly attaching to the neuromuscular relaxant, and second, there is a drug that competitively inhibits the neuromuscular relaxant by increasing the amount of ach in the neuromuscular junction. In the meantime, many studies have shown that a drug with the former mechanism (sugammadex) is superior to the latter drug (typically neostigmine) in the recovery of patients after surgery. However, there is a lack of research on whether the same research results will be shown in long COVID patients who have caused damage to the autonomic nervous system.
Therefore, in this study, sugammadex and neostigmine as described above are divided and administered to approximately 300 long COVID patients in a double-blind manner, and the degree of urinary retention is compared to prove that sugammadex is superior to neostigmine in postoperative recovery even for long COVID patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A double-blind, randomized, parallel design study
| Arm | Type | Receives |
|---|---|---|
| Sugammadex | Experimental | Drug: Sugammadex Sodiumsugammadex 2mg/kg |
| Neostigmine | Active comparator | Drug: neostigmine 50µg/kg + glycopyrollate 0.01mg/kgneostigmine 50µg/kg + glycopyrollate 0.01mg/kg |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ages between 19 and 70 Male and Female All ethnicity Patients who are scheduled to take non-emergency abdominal surgery under general anesthesia.
- Patients who had the diagnosis of covid-19 by PCR, hospitalized, and applied O2 supplement therapy.
- ASA classification ≤ 3 Patients who had Covid-19 PCR positive within 1 year Patients who had hospitalized by Covid-19, followed by O2 therapy (nasal prong, continuous positive airway pressure (CPAP), ventilator etc.) Patients who hospitalized more than 48 hours after surgery. Patients who had a surgery for more than 1 hour.
Key exclusion criteria (1 listed)
- Not meeting inclusion criteria Declined to participate Active Covid-19 patients with PCR positive. Patients are under 19 or over 70 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sugammadex SodiumAlso: BridionSugammadex Sodium 2mg/kg when TOF >= 2, postoperative period | Drug | Sugammadex |
| neostigmine 50µg/kg + glycopyrollate 0.01mg/kgAlso: neostigmineneostigmine 50µg/kg + glycopyrollate 0.01mg/kg when TOF >= 2, postoperative period | Drug | Neostigmine |
Primary outcome
urinary retention incidence
Time frame: postoperative 1 hour
urinary retention incidence
12 secondary outcomes
surgery time and anesthesia time
Time frame: perioperative period
recovery time after anesthesia
Time frame: postoperative period, within 1 hour
intraoperative blood loss
Time frame: perioperative period
perioperative vital signs
Time frame: perioperative period
additional sugammadex administration
Time frame: postoperative period, within 1 hour
bladder volume evaluated
Time frame: postoperative 1 hour
recovery score
Time frame: postoperative 1 hour
pain score
Time frame: postoperative 1 hour
urinary retention
Time frame: postoperative 24 and 48 hour
acute lesion on chest X-ray
Time frame: 2 days after surgery
actual dosage of drugs for pain and nausea control
Time frame: postoperative period, within 1 hour
other intraoperative events (awakening (eye opening), involuntary movement, occurrence of adverse events and unexpected side effects, etc.)
Time frame: perioperative period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: No. There is no plan to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Too Jae Min, M.D., Ph.D. study chair
Korea University Ansan Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sugammadex Sodium and neostigmine 50µg/kg + glycopyrollate 0.01mg/kg in people with General Anesthesia and COVID-19, run by Korea University Ansan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Too Jae Min, M.D., Ph.D. (82-10-7296-0353, minware2@nate.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
urinary retention incidence (time frame: postoperative 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.