drugset / Trial / NCT05519371

Remimazolam and Scoliosis Orthopedics

NCT05519371

Unknown 148 enrolled Beijing Chao Yang Hospital
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2022-10-01
Primary completion
2022-10-01
Completion
2023-10-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Propofol Small molecule 6 mg/kg
Comparator Propofol Small molecule 8 mg/kg
Subject Remimazolam Small molecule 1 mg/kg
Subject Remimazolam Small molecule 2 mg/kg

Indications

No indication recorded.