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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05617690
Enrollment
148
Registered
2022-11-15
Start date
2023-04-04
Completion date
2024-12-30
Last updated
2023-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Visual Evoked Potentials

Brief 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.

Interventions

DRUGCyclopol

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

DRUGPropofol

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

Sponsors

Beijing Tiantan Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
N75-p100 amplitude of FVEPIntraoperative

Countries

China

Contacts

Primary ContactJiajia Ma
majj04@126.com861059976658

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026