Clinical trial NCT05519371: Remimazolam and Scoliosis Orthopedics
Official title: Efficacy and Safety Evaluation of Injectable Remimazolam for Intraoperative Arousal in Scoliosis Orthopedics
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Benzodiazepines
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2022-08-29
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mean time to arousal
timeFrame: Perioperative period
Secondary outcomes:
measure: Quality of arousal
timeFrame: Perioperative period
measure: Proportion of successful induction of anesthesia
timeFrame: Perioperative period
measure: Mean time from initiation of dosing to MOAA/S score ≤1
timeFrame: Perioperative period
measure: Mean time from discontinuation at the end of surgery to full awakening of the subject
timeFrame: Perioperative period
measure: EEG characteristics during the induction, maintenance and awakening periods
timeFrame: Perioperative period
Other outcomes:
measure: Other adverse events
timeFrame: Postoperative 28 days
Locations:
Study officials:
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