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Comparison between low-dose and high-dose rocuronium use in general anesthesia for Cesarean section

Status Approved

  • First Submitted Date

    2020/05/04

  • Registered Date

    2020/05/06

  • Last Updated Date

    2023/12/10

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
    KCT0004986
    Unique Protocol ID H-1905-012-078
    Public/Brief Title Comparison between low-dose and high-dose rocuronium use in general anesthesia for Cesarean section
    Scientific Title Comparison between low-dose and high-dose rocuronium use in general anesthesia for Cesarean section
    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 H-1905-012-078
    Approval Date 2019-05-20
    Institutional Review Board Name Pusan national university hospital Institutional Review Board
    Institutional Review Board Address 179, Gudeok-ro, Seo-gu, Busan
    Institutional Review Board Telephone 051-240-7529
    Data Monitoring Committee No
  • 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 Boo young Hwang
    Title associate pf.
    Telephone +82-51-240-7399
    Affiliation Pusan National University Hospital
    Address Gudeok ro 179, Seo gu, Pusan, Republic of Korea
    Contact Person for Public Queries
    Name Boo young Hwang
    Title associate pf.
    Telephone +82-51-240-7399
    Affiliation Pusan National University Hospital
    Address Gudeok ro 179, Seo gu, Pusan, Republic of Korea
    Contact Person for Updating Information
    Name Boo young Hwang
    Title associate pf.
    Telephone +82-51-240-7399
    Affiliation Pusan National University Hospital
    Address Gudeok ro 179, Seo gu, Pusan, Republic of 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 Completed
    Date of First Enrollment 2019-08-01 Actual
    Target Number of Participant 20
    Primary Completion Date 2023-10-31 , Actual
    Study Completion Date 2023-11-30 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study Pusan National University Hospital
    Recruitment Status Completed
    Date of First Enrollment 2019-08-01 ,
  • 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 Pusan National University Hospital
    Organization Type Medical Institute
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Pusan National University Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    During cesarean section, rapid anesthesia induction is required by administering a high concentration of muscle relaxant to reduce the difficulty of tracheal intubation and complications caused by various general anesthetic agents. In general anesthesia, muscle relaxants are also essential for ease of surgery and reduction of body tissue damage and cardiovascular responses. However, muscle relaxants often delay breath recovery after surgery, resulting in the use of ventilators. It can also be transmitted to the fetus through the placenta. In fact, this experiment was devised to find out whether it is appropriate for a mother and a fetus to use a high concentration of muscle relaxant by measuring the concentration of muscle relaxant passing through the placenta.
    Only those applicants who have made a cesarean section due to general anesthesia by posting a recruitment notice will conduct the experiment. It is divided into a low-concentration group (0.6mg/kg) and a high-concentration group(1.0mg/kg), followed by anesthesia and muscle relaxant administration, intubation time, ease of intubation, skin incision time, umbilical cord clamping time, T1 appearing time, T2 appearing time, extubation The time, TOF0.9 time, eye open time, recovery room exit time, total rocuronium amount entered, total remifentanil amount, Apgar score, complication, etc. are recorded. After dropping 60 μl of the patient's blood onto the electrode on a screen-printed slide, and measuring the chronoamperometry after 3 minutes, obtain a current signal according to the concentration of rocuronium present in the blood and calculate the concentration of rocuronium through calculation. Layer. Rocuronium concentrations are detected in maternal venous blood just before ligation of umbilical cord blood, umbilical vein blood, and venous blood of pregnant mother just before leaving the recovery room.
    The aim is to observe the concentration of rocuronium that has actually passed umbilical cord blood, and compare side effects between both groups.
  • 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 Case-control
    Time Perspective Prospective  
    Target Number of Participant 20
    Cohort/Group Number 2
    Cohort/
    Group 1

    Cohort/Group Label

    Low dose

    Cohort/Group Description

    In a low-concentration group, we administer 0.6mg/kg rocuronium. After the induction, we check  intubation time, ease of intubation, skin incision time, umbilical cord clamping time, T1 appearing time, T2 appearing time, extubation The time, TOF0.9 time, eye open time, recovery room exit time, total rocuronium amount entered, total remifentanil amount, Apgar score, complication, etc. are recorded. After dropping 60 μl of the patient's blood onto the electrode on a screen-printed slide, and measuring the chronoamperometry after 3 minutes, obtain a current signal according to the concentration of rocuronium present in the blood and calculate the concentration of rocuronium through calculation. Rocuronium concentrations are detected in maternal venous blood just before ligation of umbilical cord blood, umbilical vein blood, and venous blood of pregnant mother just before leaving the recovery room.
    Cohort/
    Group 2

    Cohort/Group Label

    High dose

    Cohort/Group Description

    In a high-concentration group, we administer 1.0mg/kg rocuronium. After the induction, we check  intubation time, ease of intubation, skin incision time, umbilical cord clamping time, T1 appearing time, T2 appearing time, extubation The time, TOF0.9 time, eye open time, recovery room exit time, total rocuronium amount entered, total remifentanil amount, Apgar score, complication, etc. are recorded. After dropping 60 μl of the patient's blood onto the electrode on a screen-printed slide, and measuring the chronoamperometry after 3 minutes, obtain a current signal according to the concentration of rocuronium present in the blood and calculate the concentration of rocuronium through calculation. Rocuronium concentrations are detected in maternal venous blood just before ligation of umbilical cord blood, umbilical vein blood, and venous blood of pregnant mother just before leaving the recovery room.
    Biospecimen
    Collection & Archiving
    Not collect nor Archive
    Biospecimen Description
  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description
    Adult patients over 18 years of age who have undergone a cesarean section,I and II American Society of Anesthesiology.
    Sampling Method
    If the patient agrees to the experiment, the patient is assigned a random number from 1 to 20 numbers, and the odd number belongs to the high concentration and the even number falls to the low concentration group. The number of researchers per group is ten.
    Condition(s)/Problem(s) * (O00-O99)Pregnancy, childbirth and the puerperium 
       (O82.9)Delivery by caesarean section, unspecified 

    Pregnant women
    Rare Disease No
    Inclusion Criteria

    Gender

    Female

    Age

    18Year~45Year

    Description

    Adult patients over 18 years of age who have undergone a cesarean section, ASA I and II
    Exclusion Criteria
    If the patient disagrees, a neuropsychiatric disorder, a history of medication or muscle relaxant administration that may affect pre-operative muscle relaxants, kidney failure, or liver failure
    Healthy Volunteers Yes
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Efficacy
    Primary Outcome(s) 1
    Outcome
    Rocuronium concentration of umbilical vein after umbilical cord clamping
    Timepoint
    at the time of decision to leave the recovery room
    Secondary Outcome(s) 1
    Outcome
    Time from the time the muscle relaxant was given until the tracheal intubation
    Timepoint
    at the tracheal intubation
    Secondary Outcome(s) 2
    Outcome
    Skin incision time from the time the muscle relaxant was given
    Timepoint
    at the skin incision
    Secondary Outcome(s) 3
    Outcome
    Time for umbilical cord clamping from the time the muscle relaxant was given
    Timepoint
    at the umbilical cord clamping
    Secondary Outcome(s) 4
    Outcome
    Side effects in mother and fetus
    Timepoint
    at the time to leave the recovery room
    Secondary Outcome(s) 5
    Outcome
    Rocuronium concentration of maternal vein after umbilical cord clamping and PACU discharge
    Timepoint
    after umbilical cord clamping and at chiacharge from PACU
  • 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 Yes
    Results Upload
    Final Enrollment Number 18
    Number of Publication 0
    Results Upload tableresult.docx
    Date of Posting Results 2023/12/10
    Protocol URL or File Upload protocol.xlsx
    Brief Summary
    No demographic differences were observed between the two groups. Additionally, no significant differences were found in intubation ease, time from rocuronium administration to skin incision, cord clamping, TOF ratio > 0.9, eye opening, extubation, PACU stay time, 1 min and 5 min Apgar score and venous blood gas analysis of the blood from the umbilical vein between both groups. However, the time from rocuronium administration to T3 disappearance was shorter in H group than in C group (p=0.009). The time from rocuronium administration to T1 and T2 reappearance were longer in H group than in C group (p=0.003, 0.009). The administered remifentanil dose was higher in H group (p=0.042), and the rocuronium concentrations in both maternal vein immediately before cord clamping and after the Aldrete score reached 9 and umbilical vein immediately after cord clamping were higher in H group than in C group (p=0.004, 0.002, and <0.001). 
  • 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 Yes
    Time of Sharing 2021. 12
    Way of Sharing To be made available at a later date
    (byhwang@pusan.ac.kr)
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