Remimazolam and Scoliosis Orthopedics

NCT ID: NCT05519371

Last Updated: 2022-08-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2023-10-01

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.

Conditions

Benzodiazepines

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Remimazolam

Intervention Type: DRUG

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.

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.

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Chao Yang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Anshi Wu

Director of department of anesthesiology, Chaoyang Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

20220817

Identifier Type: -

Identifier Source: org_study_id