NCT05617690

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

Effect of Cyclopol on Intraoperative Electrophysiological Monitoring in Spine Surgery: A Randomized Controlled, Noninferiority Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 148 (estimated)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Visual Evoked Potentials

Interventions

Type	Name	Description
DRUG	Cyclopol	Cyclopol 0.4mg/kg, sufentanil 0.2-0.4ug/kg and rocuronium 0.6mg/kg will be used for anesthesia induction. Anesthesia maintenance strategy is cyclopol 0.8-2.4 mg/kg/h and remifentanil 0.15 - 0.2 μg/kg/h
DRUG	Propofol	Propofol 1-3mg/kg, sufentanil 0.2-0.4ug/kg and rocuronium 0.6mg/kg will be used for anesthesia induction. The anesthesia maintenance strategy is propofol 4-8mg/kg/h and remifentanil 0.15 - 0.2 μ g/kg/h

Timeline

• Start date: 2023-04-04
• Primary completion: 2024-12-01
• Completion: 2024-12-30
• First posted: 2022-11-15
• Last updated: 2023-09-13

Locations

1 site across 1 country: China