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

Study Overview
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Brief Summary
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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.

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

Conditions
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Visual Evoked Potentials

Intervention / Treatment
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* Drug: Cyclopol
* Drug: Propofol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing elective spinal surgery under general anesthesia; Intraoperative electrophysiological monitoring is required; 18-65 years old; ASA I-III; Sign the informed consent. Exclusion Criteria: Patients with visual impairment; Patients with severe liver or kidney disease; Uncontrolled hypertension, diabetes, severe arrhythmia or unstable angina pectoris; Have mental illness or unable to communicate; BMI≥30kg/㎡; Abuse of analgesics and drug abuse history; Muscle weakness, motor dysfunction or neuromuscular junction disease before operation; Preoperative somatosensory dysfunction; Retain trachea catheter after operation; Narcotic drugs and silicone allergy; Visual evoked potential monitoring was rejected.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cyclopol group<br> | Drug: Cyclopol<br>* 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<br>|
| Active Comparator: Propofol group<br> | Drug: Propofol<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| N75-p100 amplitude of FVEP |  | Intraoperative |