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

Launched by BEIJING TIANTAN HOSPITAL · Nov 8, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new method of anesthesia called total intravenous anesthesia based on cyclopol, and how it affects a test called Flash Visual Evoked Potential (FVEP) during spinal surgery. The FVEP test helps doctors monitor a patient's visual function while they are under anesthesia. This is important because changes in visual function during surgery can lead to long-term problems after the procedure. The study is comparing the effects of cyclopol to a commonly used anesthetic called propofol to see if cyclopol can better protect patients’ vision during surgery.

To participate in this trial, you need to be between 18 and 65 years old and scheduled for elective spinal surgery that requires monitoring of your visual function. You should also be generally healthy, without significant issues like severe liver or kidney disease, uncontrolled high blood pressure, or a history of drug abuse. If you choose to join the study, you can expect to receive either the cyclopol-based anesthesia or propofol, and your visual function will be monitored closely throughout your surgery. This trial is currently recruiting participants, and your involvement could help improve the safety of anesthesia used in spinal surgery for future patients.

Gender

ALL

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.