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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-04

Study Completion Date

2024-12-30

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.

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Detailed Description

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Conditions

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Visual Evoked Potentials

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Cyclopol group

Group Type EXPERIMENTAL

Cyclopol

Intervention Type DRUG

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

Propofol group

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No