Using Cyclopol for Monitoring Vision During Spine Surgery

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

This study tests if using a medication called cyclopol during spine surgery can better monitor vision compared to another drug, propofol, to help prevent vision problems after surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 148 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Beijing Tiantan Hospital (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT05617690 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of total intravenous anesthesia using cyclopol on visual evoked potentials (FVEP) during elective spinal surgeries. It aims to compare the efficacy of cyclopol against propofol in monitoring visual function under general anesthesia. By observing changes in FVEP amplitude, the study seeks to minimize the risk of postoperative visual function injuries. The research involves patients aged 18-65 who require intraoperative electrophysiological monitoring.

Who should consider this trial

Good fit: Ideal candidates are patients aged 18-65 undergoing elective spinal surgery with a need for intraoperative electrophysiological monitoring.

Not a fit: Patients with pre-existing visual impairments or severe comorbidities such as liver or kidney disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of visual function damage during spinal surgeries.

How similar studies have performed: While the specific use of cyclopol in this context may be novel, similar studies have shown that effective monitoring of visual function during surgery can improve patient outcomes.

Eligibility criteria

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.

Where this trial is running

Beijing

• Beijing Tiantan Hospital, Capital Medical University — Beijing, China (Recruiting)

Study contacts

• Principal investigator: Ruquan Han — Beijing Tiantan Hospital
• Study coordinator: Jiajia Ma

Conditions Visual Evoked Potentials