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The Effect of no Muscle Relaxant Versus Reduced-dose Rocuronium on Anesthesia in Adenotonsillectomy

Primary Purpose

Muscle Relaxants

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Rocuronium bromide 0.15 mg kg-1
Rocuronium bromide 0.3 mg kg-1
Fentanyl
Propofol
Sevoflurane
Sponsored by
Korea University Anam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Muscle Relaxants focused on measuring no muscle relaxant, rocuronium, intubation condition, tracheal intubation, operating room time, low-dose rocuronium

Eligibility Criteria

3 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • American Society of Anesthesiologist[ASA] class 1-2
  • scheduled adenotonsillectomy
  • written informed consent

Exclusion Criteria:

  • allergy of opioids, neuromuscular blocking drugs or other medications used during general anesthesia
  • known or suspected upper respiratory infection
  • disorder affecting neuromuscular blockade
  • suspected difficult tracheal intubation
  • Developmental Disability
  • known or suspected psychologic disorder
  • medication (psychoactive drugs)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Placebo Comparator

    Arm Label

    R 0.15 group

    R 0.3 group

    S group

    Arm Description

    Rocuronium bromide 0.15 mg kg-1 group Anesthesia was induced with propofol 2.5 mg kg-1 , fentanyl 2 mcg kg-1, and rocuronium bromide 0.15 mg kg-1 After mask ventilation with 5 vol% sevoflurane in 100% oxygen for 2 minutes, tracheal intubation was done. At the end of surgery, discontinuation of sevoflurane and extubation, sending recovery room. When poor intubating condition., added rocuronium bromide 0.3 mg kg-1 . Drug: Rocuronium bromide Rocuronium bromide 0.15 mg kg-1 was injected at I.V. line to patients (R 0.15 group), as muscle relaxants during anesthesia for adenotonsillectomy.

    Rocuronium bromide 0.3 mg kg-1 group Anesthesia was induced with propofol 2.5 mg kg-1 , fentanyl 2 mcg kg-1, and rocuronium bromide 0.3 mg kg-1 After mask ventilation with 5 vol% sevoflurane in 100% oxygen for 2 minutes, tracheal intubation was done. At the end of surgery, discontinuation of sevoflurane and extubation, sending recovery room. When poor intubating condition., added rocuronium bromide 0.3 mg kg-1 . Drug: Rocuronium bromide Rocuronium bromide 0.3 mg kg-1 was injected at I.V. line to patients (R 0.3 group), as muscle relaxants during anesthesia for adenotonsillectomy.

    saline Anesthesia was induced with propofol 2.5 mg kg-1 , fentanyl 2 mcg kg-1, and saline. After mask ventilation with 5 vol% sevoflurane in 100% oxygen for 2 minutes, tracheal intubation was done. At the end of surgery, discontinuation of sevoflurane and extubation, sending recovery room. When poor intubating condition., added rocuronium bromide0.3 mg kg-1 .

    Outcomes

    Primary Outcome Measures

    Conditions during tracheal intubation
    We assessed conditions during tracheal intubation as excellent, good or poor, and additionally using five variables; jaw relaxation, vocal cord position, vocal cord movement, coughing, and movement of the limbs.

    Secondary Outcome Measures

    time to extubation
    When surgery is end, we discontinue sevoflurane for maintaining anesthesia. So we check the time of this point until extubation.

    Full Information

    First Posted
    May 11, 2015
    Last Updated
    January 26, 2016
    Sponsor
    Korea University Anam Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02467595
    Brief Title
    The Effect of no Muscle Relaxant Versus Reduced-dose Rocuronium on Anesthesia in Adenotonsillectomy
    Official Title
    The Effect of no Muscle Relaxant Versus Reduced-dose Rocuronium on the Anesthetic Condition With Fentanyl in Children Undergoing Adenotonsillectomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2015 (undefined)
    Primary Completion Date
    October 2016 (Anticipated)
    Study Completion Date
    December 2016 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study aimed to compare the effect of no muscle relaxants and reduced-dose rocuronium on the anesthetic induction and emergence with fentanyl in children undergoing adenotonsillectomy.
    Detailed Description
    Adenotonsillectomy in children is a short surgical procedure under general anesthesia. The ideal muscle relaxant requires intense neuromuscular block for optimal surgical work and complete recovery of neuromuscular function immediately after the end of the surgical procedure without postoperative morbidity. Rocuronium is an intermediate acting neuromuscular blockade. Reduced-dose rocuronium has been reported to provide optimal anesthetic induction without delayed recovery. The investigators aimed to compare the effect of no muscle relaxants and reduced-dose rocuronium on the anesthetic induction and emergence with fentanyl in children undergoing adenotonsillectomy. After Institutional Review Board approval and written informed consent from the parents were obtained, 75 children (aged 3 to 10 years, ASA(The American Society of Anesthesia ) I or II) scheduled for adenotonsillectomy were included. Anesthesia was induced with propofol 2.5 mg kg-1 , fentanyl 2 mcg kg-1, and rocuronium 0.15 mg kg-1 (R 0.15 group) or rocuronium 0.3mg kg-1 (R 0.3 group) or saline (S group). After mask ventilation with 5 vol% sevoflurane in 100% oxygen for 2 minutes, tracheal intubation was done. The investigators assessed conditions during tracheal intubation as excellent, good or poor, using five variables; jaw relaxation, vocal cord position, vocal cord movement, coughing, and movement of the limbs. The investigators added rocuronium 0.3 mg kg-1 when there was more than one poor condition. The investigators recorded the time from discontinuation of sevoflurane to time to extubation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Muscle Relaxants
    Keywords
    no muscle relaxant, rocuronium, intubation condition, tracheal intubation, operating room time, low-dose rocuronium

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    75 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    R 0.15 group
    Arm Type
    Experimental
    Arm Description
    Rocuronium bromide 0.15 mg kg-1 group Anesthesia was induced with propofol 2.5 mg kg-1 , fentanyl 2 mcg kg-1, and rocuronium bromide 0.15 mg kg-1 After mask ventilation with 5 vol% sevoflurane in 100% oxygen for 2 minutes, tracheal intubation was done. At the end of surgery, discontinuation of sevoflurane and extubation, sending recovery room. When poor intubating condition., added rocuronium bromide 0.3 mg kg-1 . Drug: Rocuronium bromide Rocuronium bromide 0.15 mg kg-1 was injected at I.V. line to patients (R 0.15 group), as muscle relaxants during anesthesia for adenotonsillectomy.
    Arm Title
    R 0.3 group
    Arm Type
    Active Comparator
    Arm Description
    Rocuronium bromide 0.3 mg kg-1 group Anesthesia was induced with propofol 2.5 mg kg-1 , fentanyl 2 mcg kg-1, and rocuronium bromide 0.3 mg kg-1 After mask ventilation with 5 vol% sevoflurane in 100% oxygen for 2 minutes, tracheal intubation was done. At the end of surgery, discontinuation of sevoflurane and extubation, sending recovery room. When poor intubating condition., added rocuronium bromide 0.3 mg kg-1 . Drug: Rocuronium bromide Rocuronium bromide 0.3 mg kg-1 was injected at I.V. line to patients (R 0.3 group), as muscle relaxants during anesthesia for adenotonsillectomy.
    Arm Title
    S group
    Arm Type
    Placebo Comparator
    Arm Description
    saline Anesthesia was induced with propofol 2.5 mg kg-1 , fentanyl 2 mcg kg-1, and saline. After mask ventilation with 5 vol% sevoflurane in 100% oxygen for 2 minutes, tracheal intubation was done. At the end of surgery, discontinuation of sevoflurane and extubation, sending recovery room. When poor intubating condition., added rocuronium bromide0.3 mg kg-1 .
    Intervention Type
    Drug
    Intervention Name(s)
    Rocuronium bromide 0.15 mg kg-1
    Other Intervention Name(s)
    Esmerone
    Intervention Description
    Rocuronium bromide 0.15 mg kg-1 was injected at I.V. line to patients (R 0.15 group), as muscle relaxants during anesthesia for adenotonsillectomy.
    Intervention Type
    Drug
    Intervention Name(s)
    Rocuronium bromide 0.3 mg kg-1
    Other Intervention Name(s)
    Esmerone
    Intervention Description
    Rocuronium 0.3 mg kg-1 was injected at I.V. line to patients (R 0.3 group), as muscle relaxants during anesthesia for adenotonsillectomy.
    Intervention Type
    Drug
    Intervention Name(s)
    Fentanyl
    Other Intervention Name(s)
    하나구연산펜타닐주사
    Intervention Description
    Fentanyl 2 mcg kg-1 was injected at I.V. line to patients
    Intervention Type
    Drug
    Intervention Name(s)
    Propofol
    Other Intervention Name(s)
    Fresofol MCT 1%
    Intervention Description
    Propofol 2.5 mg kg-1 was injected at I.V. line to patients
    Intervention Type
    Drug
    Intervention Name(s)
    Sevoflurane
    Other Intervention Name(s)
    세보프란 흡입액
    Intervention Description
    After mask ventilation with 5 vol% sevoflurane in 100% oxygen for 2 minutes, tracheal intubation was done.
    Primary Outcome Measure Information:
    Title
    Conditions during tracheal intubation
    Description
    We assessed conditions during tracheal intubation as excellent, good or poor, and additionally using five variables; jaw relaxation, vocal cord position, vocal cord movement, coughing, and movement of the limbs.
    Time Frame
    At the time to tracheal intubation, after mask ventilation for 2 minutes
    Secondary Outcome Measure Information:
    Title
    time to extubation
    Description
    When surgery is end, we discontinue sevoflurane for maintaining anesthesia. So we check the time of this point until extubation.
    Time Frame
    intraoperatve
    Other Pre-specified Outcome Measures:
    Title
    Additive rocuronium
    Description
    We added rocuronium 0.3 mg kg-1 when there was more than one poor intubating condition.
    Time Frame
    intraoperatve

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Years
    Maximum Age & Unit of Time
    10 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: American Society of Anesthesiologist[ASA] class 1-2 scheduled adenotonsillectomy written informed consent Exclusion Criteria: allergy of opioids, neuromuscular blocking drugs or other medications used during general anesthesia known or suspected upper respiratory infection disorder affecting neuromuscular blockade suspected difficult tracheal intubation Developmental Disability known or suspected psychologic disorder medication (psychoactive drugs)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jang Eun Cho, M.D.,Ph.D.
    Organizational Affiliation
    Anesthesia and pain medicine department, Korea University Anam Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    28964314
    Citation
    Huh H, Park JJ, Kim JY, Kim TH, Yoon SZ, Shin HW, Lee HW, Lim HJ, Cho JE. Optimal dose of rocuronium bromide undergoing adenotonsillectomy under 5% sevoflurane with fentanyl. Int J Pediatr Otorhinolaryngol. 2017 Oct;101:70-74. doi: 10.1016/j.ijporl.2017.07.030. Epub 2017 Jul 25.
    Results Reference
    derived

    Learn more about this trial

    The Effect of no Muscle Relaxant Versus Reduced-dose Rocuronium on Anesthesia in Adenotonsillectomy

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