Remimazolam and Scoliosis Orthopedics

NCT05519371 | Unknown

• 1 other identifier: 20220817
• Study Type: interventional
• Target: 148
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Quality of arousal

  Perioperative period

• Proportion of successful induction of anesthesia

  Perioperative period

• 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

  Perioperative period

• EEG characteristics during the induction, maintenance and awakening periods

  Perioperative period

Other Outcomes (1)

• Other adverse events

  Postoperative 28 days

Study Arms (2)

remimazolam group

EXPERIMENTAL

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

propoful group

ACTIVE COMPARATOR

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

Interventions

Remimazolam 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.

remimazolam group

Propofol 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.

propoful group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Chao Yang Hospital: lead

MeSH Terms

Interventions

remimazolam; Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of department of anesthesiology, Chaoyang Hospital

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: August 29, 2022
• Study Start: October 1, 2022
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2023
• Last Updated: August 29, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share