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Remimazolam and Scoliosis Orthopedics (rimazolam)

Primary Purpose

Benzodiazepines

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Remimazolam
Propofol
Sponsored by
Beijing Chao Yang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benzodiazepines

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Criteria:

Inclusion Criteria:

  1. Age greater than 18 years and less than 60 years
  2. Elective scoliosis orthopaedic surgery under general anesthesia.
  3. ASA Physical Score I-III
  4. Signed informed consent.

Exclusion Criteria:

  1. Patients who cannot understand the method and requirements of the arousal test and cannot cooperate in completing the arousal test.
  2. Patients with limb sensory-motor dysfunction.
  3. Patients with a history of severe neurological disorders.
  4. Patients with psychiatric disorders.
  5. Patients who have taken benzodiazepines and/or opioids daily for one month or intermittently for the last three months.
  6. Patients with concomitant severe respiratory and circulatory disorders, including acute heart failure, unstable angina, resting ECG heart rate <50 beats/min, QTc: ≥ 470ms in men and ≥ 480ms in women, third-degree AV block, severe arrhythmia, moderate to severe heart valve disease, chronic obstructive pulmonary disease, and history of asthma.
  7. Abnormal liver and kidney function: ALT and/or AST exceeding 2.5 times the upper limit of the medical reference range; urea or urea nitrogen ≥1.5 × ULN, blood creatinine greater than the upper limit of normal values.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    remimazolam group

    propoful group

    Arm Description

    For induction of anesthesia, rimazolam benzoate was pumped at a rate of 12 mg/kg/h; for maintenance of anesthesia, 1.0-2.0 mg/kg/h rimazolam was given as a continuous pump.

    For induction of anesthesia, propofol medium-length chain fatty milk injection 2 mg/kg was given by intravenous push; for maintenance of anesthesia, 6-8 mg/kg/h propofol medium-length chain fatty milk injection was given by continuous pumping.

    Outcomes

    Primary Outcome Measures

    Mean time to arousal
    the time between the cessation of intraoperative drug infusion and the subject's ability to move the toes on command.

    Secondary Outcome Measures

    Quality of arousal
    Class I: the patient wakes up when called, is quiet and moves the limbs as instructed; Class II, the patient wakes up suddenly, moves the limbs involuntarily, does not endanger the internal fixation and tracheal tube, and can move the limbs as instructed; Class III, the patient wakes up suddenly, moves the trunk violently and requires pressure to not endanger the internal fixation and tracheal tube
    Proportion of successful induction of anesthesia
    The criteria for successful induction of anesthesia were that both of the following two requirements were met: completion of tracheal intubation; and no use of remedial sedative drugs
    Mean time from initiation of dosing to MOAA/S score ≤1
    Mean time from initiation of dosing to MOAA/S score ≤1
    Mean time from discontinuation at the end of surgery to full awakening of the subject
    time to the first of three consecutive MOAA/S scores of 5
    EEG characteristics during the induction, maintenance and awakening periods
    EEG power in alpha band, beta band, theta band, and gamma band

    Full Information

    First Posted
    August 16, 2022
    Last Updated
    August 25, 2022
    Sponsor
    Beijing Chao Yang Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05519371
    Brief Title
    Remimazolam and Scoliosis Orthopedics
    Acronym
    rimazolam
    Official Title
    Efficacy and Safety Evaluation of Injectable Remimazolam for Intraoperative Arousal in Scoliosis Orthopedics
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2022 (Anticipated)
    Primary Completion Date
    October 1, 2022 (Anticipated)
    Study Completion Date
    October 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Beijing Chao Yang 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
    Spinal cord injury is one of the most dangerous complications of scoliosis orthopedic surgery, and the Stagnara awakening test has been used in orthopedic spine surgery and is considered the "gold standard" for detecting spinal cord injury. During the awakening test, the patient is awakened from anesthesia and, in conjunction with a neurological assessment, moves his or her fingers and toes to determine the integrity of spinal cord motor function in order to avoid spinal cord injury. During this procedure, the patient still requires a degree of sedation and analgesia to tolerate tracheal intubation and surgical pain. Remazolam benzoate for injection is a new class of benzodiazepines that are ultra-short-acting sedative/anesthetic drugs. It has the advantages of rapid onset, rapid elimination, and no drug accumulation by continuous infusion, and has the advantage of being applied to wake up during spinal orthopedic surgery, but its effectiveness and safety are still unclear. This study aims to elucidate the safety and efficacy of rimazolam benzoate for injection for arousal in spinal orthopedic surgery through a single-center, randomized, single-blind, positive drug-controlled trial, with the aim of providing a basis for the development of a safe and effective anesthetic protocol for such surgery.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    remimazolam group
    Arm Type
    Experimental
    Arm Description
    For induction of anesthesia, rimazolam benzoate was pumped at a rate of 12 mg/kg/h; for maintenance of anesthesia, 1.0-2.0 mg/kg/h rimazolam was given as a continuous pump.
    Arm Title
    propoful group
    Arm Type
    Active Comparator
    Arm Description
    For induction of anesthesia, propofol medium-length chain fatty milk injection 2 mg/kg was given by intravenous push; for maintenance of anesthesia, 6-8 mg/kg/h propofol medium-length chain fatty milk injection was given by continuous pumping.
    Intervention Type
    Drug
    Intervention Name(s)
    Remimazolam
    Intervention Description
    During induction of anesthesia, the rimazolam group was given rimazolam pumped at a rate of 12 mg/kg/h During the maintenance phase of anesthesia, the rimazolam group was given 1.0-2.0 mg/kg/h of rimazolam continuously pumped.
    Intervention Type
    Drug
    Intervention Name(s)
    Propofol
    Intervention Description
    During induction of anesthesia, propofol 2mg/kg was given, and during the maintenance phase of anesthesia, propofol 6-8mg/kg/h was given as a continuous pump.
    Primary Outcome Measure Information:
    Title
    Mean time to arousal
    Description
    the time between the cessation of intraoperative drug infusion and the subject's ability to move the toes on command.
    Time Frame
    Perioperative period
    Secondary Outcome Measure Information:
    Title
    Quality of arousal
    Description
    Class I: the patient wakes up when called, is quiet and moves the limbs as instructed; Class II, the patient wakes up suddenly, moves the limbs involuntarily, does not endanger the internal fixation and tracheal tube, and can move the limbs as instructed; Class III, the patient wakes up suddenly, moves the trunk violently and requires pressure to not endanger the internal fixation and tracheal tube
    Time Frame
    Perioperative period
    Title
    Proportion of successful induction of anesthesia
    Description
    The criteria for successful induction of anesthesia were that both of the following two requirements were met: completion of tracheal intubation; and no use of remedial sedative drugs
    Time Frame
    Perioperative period
    Title
    Mean time from initiation of dosing to MOAA/S score ≤1
    Description
    Mean time from initiation of dosing to MOAA/S score ≤1
    Time Frame
    Perioperative period
    Title
    Mean time from discontinuation at the end of surgery to full awakening of the subject
    Description
    time to the first of three consecutive MOAA/S scores of 5
    Time Frame
    Perioperative period
    Title
    EEG characteristics during the induction, maintenance and awakening periods
    Description
    EEG power in alpha band, beta band, theta band, and gamma band
    Time Frame
    Perioperative period
    Other Pre-specified Outcome Measures:
    Title
    Other adverse events
    Description
    Other adverse events within 28 days after surgery were noted
    Time Frame
    Postoperative 28 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Criteria: Inclusion Criteria: Age greater than 18 years and less than 60 years Elective scoliosis orthopaedic surgery under general anesthesia. ASA Physical Score I-III Signed informed consent. Exclusion Criteria: Patients who cannot understand the method and requirements of the arousal test and cannot cooperate in completing the arousal test. Patients with limb sensory-motor dysfunction. Patients with a history of severe neurological disorders. Patients with psychiatric disorders. Patients who have taken benzodiazepines and/or opioids daily for one month or intermittently for the last three months. Patients with concomitant severe respiratory and circulatory disorders, including acute heart failure, unstable angina, resting ECG heart rate <50 beats/min, QTc: ≥ 470ms in men and ≥ 480ms in women, third-degree AV block, severe arrhythmia, moderate to severe heart valve disease, chronic obstructive pulmonary disease, and history of asthma. Abnormal liver and kidney function: ALT and/or AST exceeding 2.5 times the upper limit of the medical reference range; urea or urea nitrogen ≥1.5 × ULN, blood creatinine greater than the upper limit of normal values.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Remimazolam and Scoliosis Orthopedics

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