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Deep Neuromuscular Blockade in Strabismus Surgery

Primary Purpose

Strabismus

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
moderate to deep neuromuscular blockade
shallow to minimal neuromuscular blockade
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Strabismus

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Pediatric patients between the ages of 3 and 18 who are American Society of Anesthesiologists physical classification (ASA) I, II, or III scheduled for strabismus surgery under general anesthesia. Exclusion Criteria: Patients with underlying cardiovascular disease Patients with preoperative electrocardiograms showing conduction disturbances Patients with neuromuscular disease Any other patient who, in the opinion of the investigator, is not a good candidate for the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    block group

    control group

    Arm Description

    Maintaining moderate to deep neuromuscular blockade during an intraoperative period (Train-of-four 0-3, post-tetanic count > 1) Rocuronium (intravenous, 1.0 mg/kg)

    Maintaining shallow to minimal neuromuscular blockade during an intraoperative period (Train-of-four 4, post-tetanic count < 0.9) Rocuronium (intravenous, 0.3 mg/kg)

    Outcomes

    Primary Outcome Measures

    The incidence of grade 2 or greater oculocardiac reflex (induced)
    > 20% reduction in heart rate induced by intentional manipulation of the inferior rectus muscle

    Secondary Outcome Measures

    The incidence of grade 1 oculocardiac reflex (induced)
    < 20% reduction in heart rate induced by intentional manipulation of the inferior rectus muscle
    The incidence of grade 2 or greater oculocardiac reflex (during strabismus surgery)
    > 20% reduction in heart rate during strabismus surgery
    The incidence of grade 1 greater oculocardiac reflex (during strabismus surgery)
    < 20% reduction in heart rate during strabismus surgery
    Number of times Rescue IV Atropine has been used for oculocardiac reflex
    Number of times Rescue IV Atropine has been used (0.02mg/kg) for oculocardiac reflex
    The incidence of hypotension
    The incidence of hypotension, defined as a drop to 20% or more of baseline mean blood pressure
    Postoperative nausea/vomiting
    Presence of postoperative nausea/vomiting as assessed in the recovery room

    Full Information

    First Posted
    May 22, 2023
    Last Updated
    May 31, 2023
    Sponsor
    Seoul National University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05882643
    Brief Title
    Deep Neuromuscular Blockade in Strabismus Surgery
    Official Title
    The Effect of the Deep Neuromuscular Block on the Refraction and the Oculocardiac Reflex During Strabismus Surgery in Pediatric Patients - a Prospective Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2023 (Anticipated)
    Primary Completion Date
    June 1, 2026 (Anticipated)
    Study Completion Date
    June 1, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Seoul National University 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
    The purpose of this study is to determine if inducing a moderate or greater neuromuscular block (TOF count 0-3) when performing a neuromuscular block in pediatric patients aged 3 to 18 years undergoing strabismus surgery under general anesthesia can reduce the incidence of the oculocardiac reflex.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Strabismus

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    204 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    block group
    Arm Type
    Experimental
    Arm Description
    Maintaining moderate to deep neuromuscular blockade during an intraoperative period (Train-of-four 0-3, post-tetanic count > 1) Rocuronium (intravenous, 1.0 mg/kg)
    Arm Title
    control group
    Arm Type
    Active Comparator
    Arm Description
    Maintaining shallow to minimal neuromuscular blockade during an intraoperative period (Train-of-four 4, post-tetanic count < 0.9) Rocuronium (intravenous, 0.3 mg/kg)
    Intervention Type
    Other
    Intervention Name(s)
    moderate to deep neuromuscular blockade
    Intervention Description
    Maintaining moderate to deep neuromuscular blockade during an intraoperative period (Train-of-four 0-3 count, post-tetanic count > 1) Rocuronium (intravenous, 1.0 mg/kg at induction period)
    Intervention Type
    Other
    Intervention Name(s)
    shallow to minimal neuromuscular blockade
    Intervention Description
    Maintaining shallow to minimal neuromuscular blockade during an intraoperative period (Train-of-four 4, post-tetanic count < 0.9) Rocuronium (intravenous, 0.3 mg/kg at induction period)
    Primary Outcome Measure Information:
    Title
    The incidence of grade 2 or greater oculocardiac reflex (induced)
    Description
    > 20% reduction in heart rate induced by intentional manipulation of the inferior rectus muscle
    Time Frame
    During induced oculocardiac reflex test by ophthalmologists
    Secondary Outcome Measure Information:
    Title
    The incidence of grade 1 oculocardiac reflex (induced)
    Description
    < 20% reduction in heart rate induced by intentional manipulation of the inferior rectus muscle
    Time Frame
    During induced oculocardiac reflex test by ophthalmologists
    Title
    The incidence of grade 2 or greater oculocardiac reflex (during strabismus surgery)
    Description
    > 20% reduction in heart rate during strabismus surgery
    Time Frame
    During general anesthesia for strabismus surgery (within 2 hour)
    Title
    The incidence of grade 1 greater oculocardiac reflex (during strabismus surgery)
    Description
    < 20% reduction in heart rate during strabismus surgery
    Time Frame
    During general anesthesia for strabismus surgery (usually within 2 hour)
    Title
    Number of times Rescue IV Atropine has been used for oculocardiac reflex
    Description
    Number of times Rescue IV Atropine has been used (0.02mg/kg) for oculocardiac reflex
    Time Frame
    During general anesthesia for strabismus surgery (within 2 hour)
    Title
    The incidence of hypotension
    Description
    The incidence of hypotension, defined as a drop to 20% or more of baseline mean blood pressure
    Time Frame
    During general anesthesia for strabismus surgery (within 2 hour)
    Title
    Postoperative nausea/vomiting
    Description
    Presence of postoperative nausea/vomiting as assessed in the recovery room
    Time Frame
    From extubation to post-anesthesia care unit stay (within 1 hour)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Pediatric patients between the ages of 3 and 18 who are American Society of Anesthesiologists physical classification (ASA) I, II, or III scheduled for strabismus surgery under general anesthesia. Exclusion Criteria: Patients with underlying cardiovascular disease Patients with preoperative electrocardiograms showing conduction disturbances Patients with neuromuscular disease Any other patient who, in the opinion of the investigator, is not a good candidate for the study.

    12. IPD Sharing Statement

    Learn more about this trial

    Deep Neuromuscular Blockade in Strabismus Surgery

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