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Relationship between timing of sugammadex administration and the upper airway obstruction during awakening from anesthesia – A retrospective study

Status Approved

  • First Submitted Date

    2018/10/11

  • Registered Date

    2018/11/16

  • Last Updated Date

    2020/12/17

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0003356
    Unique Protocol ID HPIRB 2018-08-005-001
    Public/Brief Title The timing of sugammadex administration
    Scientific Title Relationship between timing of sugammadex administration and the upper airway obstruction during awakening from anesthesia – A retrospective study
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number HPIRB 2018-08-005-001
    Approval Date 2018-09-27
    Institutional Review Board Name Institutional review board of Haeundae Paik hospital, Inje University
    Institutional Review Board Address 875, Haeun-daero, Haeundae-gu, Busan
    Institutional Review Board Telephone 051-797-2747
    Data Monitoring Committee
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Myoung Jin Ko
    Title Dr.
    Telephone +82-51-797-0423
    Affiliation Inje University Haeundae Paik Hospital
    Address Haeundaero 875, Haeundae-gu, Busan, South Korea
    Contact Person for Public Queries
    Name Myoung Jin Ko
    Title Dr.
    Telephone +82-51-797-0423
    Affiliation Inje University Haeundae Paik Hospital
    Address Haeundaero 875, Haeundae-gu, Busan, South Korea
    Contact Person for Updating Information
    Name Myoung Jin Ko
    Title Dr.
    Telephone +82-51-797-0423
    Affiliation Inje University Haeundae Paik Hospital
    Address Haeundaero 875, Haeundae-gu, Busan, South Korea
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Recruiting
    Date of First Enrollment 2018-10-11 Actual
    Target Number of Participant 3391
    Primary Completion Date
    Study Completion Date
    Recruitment Status by Participating Study Site 1
    Name of Study Inje University Haeundae Paik Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2018-10-11 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Inje University Haeundae Paik Hospital
    Organization Type Medical Institute
    Project ID HPIRB2018-08-005-001
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Inje University Haeundae Paik Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    An optimal time is important for medication administration. Onset of the medication and interaction with other drugs should be considered to maximize the therapeutic effects and minimize adverse effects. The medications for reversal of muscle relaxants after general anesthesia have such an optimal time. For example, pyridostigmine or neostigmine should be administered when train of four (TOF) count is equal to or greater than 2, or the sign of spontaneous ventilation is present. These drugs are anticholinesterases that inhibit hydrolysis of acetylcholine and allow more acetylcholine available at synapses of neuromuscular junction to compete with the nondepolarizing agents and decrease the neuromuscular blockade. 
    Administration of reversal agents once evidence of spontaneous recovery or 2 or more twitches of the train-of-four (TOF) stimulation is present has a strong correlation with therapeutic durations of the reversal agents. As the muscle relaxants used for general anesthesia have longer therapeutic durations than anticholinesterases, reversal agents should be given in presence of 2nd twitch of TOF to avoid recurarization caused by the residual neuromuscular blocking agents of which duration lasts longer than that of the anticholinesterase drugs. In contrast, sugammadex can be given even if there is no response to TOF stimulation. Sugammadex is a modified γ-cyclodextrin and the selective relaxant–binding agent to inactivate the specific non-depolarizing neuromuscular blocking agents. A medium dose (4 mg/kg) of intravenous sugammadex is recommended during deep block (two or more responses to PTC), and a low dose (2 mg/kg) for moderate block (two or more responses to TOF stimulation). In most patients, all levels of neuromuscular block are reversed within 2 to 3 minutes. However, the effect of different administration timing on the emergence has not been studied in association with anesthetic depth. Rapid reversal of rocuronium-induced neuromuscular blockade may affect the emergence depending on the residual volatile anesthetics and the aim of this study is to find the appropriate timing of sugammadex administration.
    
    Study design
    The effect of different timings of sugammadex administration on emergence reactions was analyzed in all the patients who had surgery under general anesthesia at Haeundae Paik Hospital between October 2017 and July 2018 and received intravenous sugammadex to reverse rocuronium-induced neuromuscular blockade. All electronic medical records were reviewed retrospectively except those of the excluded patients, including preoperative evaluations, anesthesia records, records at PACU and nursing information surveys, in order to collect data on end-tidal volatile anesthetic concentrations, Bispectral Index (BIS) and Minimal alveolar concentration (MAC) at the time of sugammadex administration. Durations in minutes between the discontinuation of anesthetics and the sugammadex administration, time to extubate, time to exit the operating room, the incidence of complications after extubation (upper airway obstruction, vocal cord spasm, hypoxia, hypoventilation, severed cough or other events), and RASS at extubation were also collected to investigate how different timing of sugammadex administration affected the emergence reactions.
  • 8. Study Design

    Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
    Study Type Observational Study
    Observational Study Model Others
    Time Perspective Retrospective  
    Target Number of Participant 3391
    Cohort/Group Number 1
    Cohort/
    Group 1

    Cohort/Group Label

    Sugammadex group

    Cohort/Group Description

    The effect of different timings of sugammadex administration on emergence reactions was analyzed in all the patients who had surgery under general anesthesia at Haeundae Paik Hospital between October 2017 and July 2018 and received intravenous sugammadex to reverse rocuronium-induced neuromuscular blockade. All electronic medical records were reviewed retrospectively except those of the excluded patients, including preoperative evaluations, anesthesia records, records at PACU and nursing information surveys, in order to collect data on end-tidal volatile anesthetic concentrations, Bispectral Index (BIS) and Minimal alveolar concentration (MAC) at the time of sugammadex administration. Durations in minutes between the discontinuation of anesthetics and the sugammadex administration, time to extubate, time to exit the operating room, the incidence of complications after extubation (upper airway obstruction, vocal cord spasm, hypoxia, hypoventilation, severed cough or other events), and RASS at extubation were also collected to investigate how different timing of sugammadex administration affected the emergence reactions.
    Biospecimen
    Collection & Archiving
    Not collect nor Archive
    Biospecimen Description
  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description
    Patients who had surgery under general anesthesia at Haeundae Paik Hospital and received sugammadex to reverse rocuronium-induced neuromuscular blockade
    Sampling Method
    Non-probability sampling (The samples were extracted by investigating the cases of sugammadex prescription during the period(complete observation between October 2017 and July 2018), and the information provided by Health Information Management department of Haeundae Paik Hospital.)
    Condition(s)/Problem(s) * (V01-Y98)External causes of morbidity and mortality 
       (Y55.1)Skeletal muscle relaxants [neuromuscular blocking agents] causing adverse effects in therapeutic use 

    Patients who had surgery under general anesthesia
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    No Limit~No Limit

    Description

    Patients who had surgery under general anesthesia at Haeundae Paik Hospital and received intravenous sugammadex to reverse rocuronium-induced neuromuscular blockade
    Exclusion Criteria
    1)	Patients whose monitoring parameters were lacking in electronic medical records (for example, BIS, end-tidal volatile anesthetic concentration, MAC)
    2)	Total intravenous anesthesia
    3)	Concomitant use of other reversal agents (for example, pyridostigmine)
    4)	Administration of sugammadex after extubation
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome /Safety/Efficacy
    Primary Outcome(s) 1
    Outcome
    occurrence and types of complications after extubation
    Timepoint
    emergence from general anesthesia and tracheal extubation
    Secondary Outcome(s) 1
    Outcome
    time to extubate from discontinuation of anesthetics
    Timepoint
    tracheal extubation
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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