Remimazolam and Scoliosis Orthopedics (rimazolam)

Efficacy and Safety Evaluation of Injectable Remimazolam for Intraoperative Arousal in Scoliosis Orthopedics

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Benzodiazepines
• Intervention / Treatment: Drug: Remimazolam; Drug: Propofol

• Study Type: Interventional
• Enrollment (Anticipated): 148
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: remimazolam group; 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.	Drug: Remimazolam; 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.
Active Comparator: propoful group; 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.	Drug: Propofol; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean time to arousal	the time between the cessation of intraoperative drug infusion and the subject's ability to move the toes on command.	Perioperative period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Perioperative period
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	Perioperative period
Mean time from initiation of dosing to MOAA/S score ≤1	Mean time from initiation of dosing to MOAA/S score ≤1	Perioperative period
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	Perioperative period
EEG characteristics during the induction, maintenance and awakening periods	EEG power in alpha band, beta band, theta band, and gamma band	Perioperative period

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Other adverse events	Other adverse events within 28 days after surgery were noted	Postoperative 28 days

Collaborators and Investigators

• Sponsor: Beijing Chao Yang Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2022
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: August 16, 2022
• First Submitted That Met QC Criteria: August 25, 2022
• First Posted (Actual): August 29, 2022

Study Record Updates

• Last Update Posted (Actual): August 29, 2022
• Last Update Submitted That Met QC Criteria: August 25, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: 20220817

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No