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Influence of Neostigmine vs. Sugammadex on PORC and PPCs by Ultrasonography

Primary Purpose

Postoperative Pulmonary Complications

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
sugammadex as reversal drugs
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pulmonary Complications focused on measuring postoperative pulmonary complications, postoperative residual curarisation, lung ultrasound, diaphragm ultrasonography

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. American Society of Anesthesiologists (ASA) physical status I-III
  2. Aged over 60 years
  3. Anesthesia induction with rocuronium as NMBAs, maintenance with volatile sevoflurane
  4. Scheduled to undertake joint surgery
  5. Signed the informed consent form

Exclusion Criteria:

  1. Those with a history of hepatic or renal disease, chronic or acute alcoholism, allergy or hypersensitivity to sugammadex or neostigmine, current medication with effects on the central nervous system, a history of dysfunction of neuromuscular system
  2. Those with diaphragm insufficiency or massive pleural effusion
  3. Women who are pregnant or nursing
  4. Those undergoing upper abdominal laparotomy, after which we cannot obtain a satisfactory ultrasound imaging or do not have space for placement of ultrasonic probe
  5. Declined to participate

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    SUG group

    NEO group

    Arm Description

    sugammadex as reversal drugs

    neostigmine as reversal drugs

    Outcomes

    Primary Outcome Measures

    incidence of postoperative pulmonary complications
    incidence of postoperative pulmonary complications

    Secondary Outcome Measures

    Evaluation of diaphragmatic and pulmonary function by means of diaphragm and lung ultrasonography
    Evaluation of diaphragmatic and pulmonary function by means of diaphragm and lung ultrasonography(LUS)

    Full Information

    First Posted
    August 25, 2021
    Last Updated
    September 3, 2021
    Sponsor
    Peking Union Medical College Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05040490
    Brief Title
    Influence of Neostigmine vs. Sugammadex on PORC and PPCs by Ultrasonography
    Official Title
    Comparison of the Effects of Neostigmine and Sugammadex on Postoperative Residual Curarization and Postoperative Pulmonary Complications Detected by Diaphragm and Lung Ultrasonography: A Study Protocol for Prospective Double-blind Randomized Controlled Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 31, 2021 (Anticipated)
    Primary Completion Date
    July 2022 (Anticipated)
    Study Completion Date
    September 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Peking Union Medical College Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This trial aims to compare the incidence of postoperative residual curarisation (PORC) and postoperative pulmonary complications (PPCs) in the SUG and NEO group by means of diaphragm ultrasonography and LUS, so as to conclude whether SUG can outperform NEO in preventing occurrence of PORC and PPCs.
    Detailed Description
    The incidence of postoperative residual curarisation (PORC) is about 2%-64% worldwide, which may be an underling risk factor of postoperative pulmonary complications (PPCs), causing many undesirable effects on patients. Thus, reversal drugs of neuromuscular blocking agents (NMBAs) such as neostigmine (NEO) and sugammadex (SUG) have been administrated, and SUG maybe perform better in preventing PORC. Different supplementary methods to help identify PORC or PPCs have also been reported, such as adductor of pollicis acceleromyography and lung ultrasound (LUS). Recently, diaphragm ultrasonography has been used to evaluate PORC, as a novel approach.In this prospective, double-blind, randomized controlled trial, we will enroll 414 patients of American Society of Anesthesiologists physical status I-III, aged over 60 years, who will be scheduled to undergo arthroplasty surgery under general anesthesia. Participants will be randomized into NEO and SUG group receiving neostigmine and sugammadex as reversal drug respectively. The primary outcomes will be the incidence of PPCs in NEO and SUG group respectively. The secondary outcome is the incidence of PORC in the two groups.We hypothesize that: 1) the incidence of PPCs is lower after reversal with SUG than with NEO, 2) using the method of diaphragm ultrasonography, the incidence PORC is lower after reversal with SUG than with NEO, 3) the incidence of PPCs can be predicted by LUS and by evaluating whether there is PORC through diaphragmatic ultrasound.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Pulmonary Complications
    Keywords
    postoperative pulmonary complications, postoperative residual curarisation, lung ultrasound, diaphragm ultrasonography

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    414 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    SUG group
    Arm Type
    Experimental
    Arm Description
    sugammadex as reversal drugs
    Arm Title
    NEO group
    Arm Type
    No Intervention
    Arm Description
    neostigmine as reversal drugs
    Intervention Type
    Drug
    Intervention Name(s)
    sugammadex as reversal drugs
    Intervention Description
    use sugammadex to reverse neuromuscular blockade
    Primary Outcome Measure Information:
    Title
    incidence of postoperative pulmonary complications
    Description
    incidence of postoperative pulmonary complications
    Time Frame
    30 days after surgery
    Secondary Outcome Measure Information:
    Title
    Evaluation of diaphragmatic and pulmonary function by means of diaphragm and lung ultrasonography
    Description
    Evaluation of diaphragmatic and pulmonary function by means of diaphragm and lung ultrasonography(LUS)
    Time Frame
    preoperatively, 10min and 30min after extubation for diaphragm ultrasonography and LUS
    Other Pre-specified Outcome Measures:
    Title
    sedation score
    Description
    sedation score OAAS
    Time Frame
    10min and 30min after extubation
    Title
    duration of hospitalization
    Description
    duration of hospitalization
    Time Frame
    30 days after surgery
    Title
    dosage of intravenous and inhaling sedative drug, analgesia drug, NMBAs
    Description
    dosage of intravenous and inhaling sedative drug, analgesia drug, NMBAs
    Time Frame
    30 days after surgery
    Title
    duration of surgery and anesthesia
    Description
    duration of surgery and anesthesia
    Time Frame
    30 days after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status I-III Aged over 60 years Anesthesia induction with rocuronium as NMBAs, maintenance with volatile sevoflurane Scheduled to undertake joint surgery Signed the informed consent form Exclusion Criteria: Those with a history of hepatic or renal disease, chronic or acute alcoholism, allergy or hypersensitivity to sugammadex or neostigmine, current medication with effects on the central nervous system, a history of dysfunction of neuromuscular system Those with diaphragm insufficiency or massive pleural effusion Women who are pregnant or nursing Those undergoing upper abdominal laparotomy, after which we cannot obtain a satisfactory ultrasound imaging or do not have space for placement of ultrasonic probe Declined to participate
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    CHEN YING
    Phone
    +8619801103037
    Email
    ddlondon@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    ZHANG YUGUAN, doctoral
    Organizational Affiliation
    Peking Union Medical College Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    35526047
    Citation
    Zhang YG, Chen Y, Zhang YL, Yi J. Comparison of the effects of neostigmine and sugammadex on postoperative residual curarization and postoperative pulmonary complications by means of diaphragm and lung ultrasonography: a study protocol for prospective double-blind randomized controlled trial. Trials. 2022 May 7;23(1):376. doi: 10.1186/s13063-022-06328-3.
    Results Reference
    derived

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    Influence of Neostigmine vs. Sugammadex on PORC and PPCs by Ultrasonography

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