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

Beijing Tiantan Hospital148 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

148

Conditions

Visual Evoked Potentials

Interventions

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

PropofolDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients undergoing elective spinal surgery under general anesthesia; 2. Intraoperative electrophysiological monitoring is required; 3. 18-65 years old; 4. ASA I-III; 5. Sign the informed consent. Exclusion Criteria: 1. Patients with visual impairment; 2. Patients with severe liver or kidney disease; 3. Uncontrolled hypertension, diabetes, severe arrhythmia or unstable angina pectoris; 4. Have mental illness or unable to communicate; 5. BMI≥30kg/㎡; 6. Abuse of analgesics and drug abuse history; 7. Muscle weakness, motor dysfunction or neuromuscular junction disease before operation; 8. Preoperative somatosensory dysfunction; 9. Retain trachea catheter after operation; 10. Narcotic drugs and silicone allergy; 11. Visual evoked potential monitoring was rejected.

Locations (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, China

RECRUITING

Outcomes

Primary Outcomes

N75-p100 amplitude of FVEP

Time frame: Intraoperative

Central Contacts

Jiajia Ma

CONTACT

861059976658 majj04@126.com

Data from ClinicalTrials.gov

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