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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05519371
Other study ID # 20220817
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 1, 2022
Est. completion date October 1, 2023

Study information

Verified date August 2022
Source Beijing Chao Yang Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Beijing Chao Yang Hospital

Outcome

Type Measure Description Time frame Safety issue
Other Other adverse events Other adverse events within 28 days after surgery were noted Postoperative 28 days
Primary 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 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
Secondary 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
Secondary Mean time from initiation of dosing to MOAA/S score =1 Mean time from initiation of dosing to MOAA/S score =1 Perioperative period
Secondary 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
Secondary EEG characteristics during the induction, maintenance and awakening periods EEG power in alpha band, beta band, theta band, and gamma band Perioperative period
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