drugset / Trial / NCT05617690

Cyclopol on Electrophysiological Monitoring During Spine Surgery: a Randomized Controlled, Noninferiority Study

NCT05617690 ↗

Unknown 148 enrolled Beijing Tiantan Hospital
RandomizedParallel-groupDouble-blindPrevention

Summary

Postoperative visual function injury occurs after spinal cord, neurosurgery, ophthalmology and other operations, which directly affects the postoperative quality of life of patients. Flash visual evoked potential (FVEP) is important for evaluating visual function under general anesthesia during operation. The changes of visual function can be observed and recognized in time through the amplitude changes of FVEP, which can avoid or reduce the visual function damage during operation. Anesthesia method determines the success and variability of electrophysiological monitoring to a certain extent. The purpose of this study is to investigate the effect of total intravenous anesthesia based on cyclopol on FVEP compared with propofol.

Timeline

Start
2023-04-04
Primary completion
2024-12-01
Completion
2024-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclopol Unknown 0.8 mg/kg Intravenous
Subject Cyclopol Unknown 2.4 mg/kg Intravenous
Comparator Propofol Small molecule 4 mg/kg —
Comparator Propofol Small molecule 8 mg/kg —