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Postoperative Sugammadex After COVID-19

Primary Purpose

General Anesthesia, COVID-19

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Sugammadex Sodium
neostigmine 50µg/kg + glycopyrollate 0.01mg/kg
Sponsored by
Korea University Ansan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for General Anesthesia focused on measuring COVID-19, Postoperative Complications

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: Not meeting inclusion criteria Declined to participate Active Covid-19 patients with PCR positive. Patients are under 19 or over 70 years old

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Sugammadex

    Neostigmine

    Arm Description

    sugammadex 2mg/kg

    neostigmine 50µg/kg + glycopyrollate 0.01mg/kg

    Outcomes

    Primary Outcome Measures

    urinary retention incidence
    urinary retention incidence

    Secondary Outcome Measures

    surgery time and anesthesia time
    surgery time and anesthesia time
    recovery time after anesthesia
    recovery time after anesthesia
    intraoperative blood loss
    estimated blood loss
    perioperative vital signs
    serial follow up during surgery and postoperative recovery room
    additional sugammadex administration
    incidence and dosage
    bladder volume evaluated
    Sono-calculated (summation of self-voiding volume during self-voiding)
    recovery score
    postoperative recovery score at PACU
    pain score
    NRS
    urinary retention
    presence of complication
    acute lesion on chest X-ray
    presence of complication
    actual dosage of drugs for pain and nausea control
    pain (ketorolac, fentanyl, tramadol, acetaminophen, nalbuphine, pethidcine, ketoprofen, propacetamol) nausea(ramosetron, metoclopramide, palonosetron)
    other intraoperative events (awakening (eye opening), involuntary movement, occurrence of adverse events and unexpected side effects, etc.)
    presence of complication

    Full Information

    First Posted
    April 11, 2023
    Last Updated
    April 16, 2023
    Sponsor
    Korea University Ansan Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05817019
    Brief Title
    Postoperative Sugammadex After COVID-19
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 20, 2023 (Anticipated)
    Primary Completion Date
    December 25, 2024 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Korea University Ansan Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    General Anesthesia, COVID-19
    Keywords
    COVID-19, Postoperative Complications

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    A double-blind, randomized, parallel design study
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    The neuromuscular reversal agent is received and prepared in advance by a separate medical staff (a separate anesthesiologist who does not participate in the patient's anesthesia), and the corresponding prescription order is made separately when the patient leaves the recovery room. Since it is diluted with physiological saline and prepared in a total amount of 5cc, the patient and the patient's anesthetist do not know about the drug until they leave the recovery room (double-blinded).
    Allocation
    Randomized
    Enrollment
    300 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Sugammadex
    Arm Type
    Experimental
    Arm Description
    sugammadex 2mg/kg
    Arm Title
    Neostigmine
    Arm Type
    Active Comparator
    Arm Description
    neostigmine 50µg/kg + glycopyrollate 0.01mg/kg
    Intervention Type
    Drug
    Intervention Name(s)
    Sugammadex Sodium
    Other Intervention Name(s)
    Bridion
    Intervention Description
    Sugammadex Sodium 2mg/kg when TOF >= 2, postoperative period
    Intervention Type
    Drug
    Intervention Name(s)
    neostigmine 50µg/kg + glycopyrollate 0.01mg/kg
    Other Intervention Name(s)
    neostigmine
    Intervention Description
    neostigmine 50µg/kg + glycopyrollate 0.01mg/kg when TOF >= 2, postoperative period
    Primary Outcome Measure Information:
    Title
    urinary retention incidence
    Description
    urinary retention incidence
    Time Frame
    postoperative 1 hour
    Secondary Outcome Measure Information:
    Title
    surgery time and anesthesia time
    Description
    surgery time and anesthesia time
    Time Frame
    perioperative period
    Title
    recovery time after anesthesia
    Description
    recovery time after anesthesia
    Time Frame
    postoperative period, within 1 hour
    Title
    intraoperative blood loss
    Description
    estimated blood loss
    Time Frame
    perioperative period
    Title
    perioperative vital signs
    Description
    serial follow up during surgery and postoperative recovery room
    Time Frame
    perioperative period
    Title
    additional sugammadex administration
    Description
    incidence and dosage
    Time Frame
    postoperative period, within 1 hour
    Title
    bladder volume evaluated
    Description
    Sono-calculated (summation of self-voiding volume during self-voiding)
    Time Frame
    postoperative 1 hour
    Title
    recovery score
    Description
    postoperative recovery score at PACU
    Time Frame
    postoperative 1 hour
    Title
    pain score
    Description
    NRS
    Time Frame
    postoperative 1 hour
    Title
    urinary retention
    Description
    presence of complication
    Time Frame
    postoperative 24 and 48 hour
    Title
    acute lesion on chest X-ray
    Description
    presence of complication
    Time Frame
    2 days after surgery
    Title
    actual dosage of drugs for pain and nausea control
    Description
    pain (ketorolac, fentanyl, tramadol, acetaminophen, nalbuphine, pethidcine, ketoprofen, propacetamol) nausea(ramosetron, metoclopramide, palonosetron)
    Time Frame
    postoperative period, within 1 hour
    Title
    other intraoperative events (awakening (eye opening), involuntary movement, occurrence of adverse events and unexpected side effects, etc.)
    Description
    presence of complication
    Time Frame
    perioperative period

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: Not meeting inclusion criteria Declined to participate Active Covid-19 patients with PCR positive. Patients are under 19 or over 70 years old
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Too Jae Min, M.D., Ph.D.
    Phone
    82-10-7296-0353
    Email
    minware2@nate.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sang Min Yoon, M.D.
    Phone
    82-10-8805-8619
    Email
    ekha00041@naver.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Too Jae Min, M.D., Ph.D.
    Organizational Affiliation
    Korea University Ansan Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    There is no plan to share IPD

    Learn more about this trial

    Postoperative Sugammadex After COVID-19

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