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

Sponsor

Beijing Tiantan Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05617690

Collaborator

(none)

148

Enrollment

Location

Arms

13.5

Anticipated Duration (Months)

10.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Visual Evoked Potentials	Drug: Cyclopol Drug: Propofol	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

148 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Nov 15, 2022

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cyclopol group	Drug: 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
Active Comparator: Propofol group	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

Arm

Intervention/Treatment

Experimental: Cyclopol group

Drug: 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

Active Comparator: Propofol group

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

Outcome Measures

Primary Outcome Measures

N75-p100 amplitude of FVEP [Intraoperative]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients undergoing elective spinal surgery under general anesthesia;
Intraoperative electrophysiological monitoring is required;
18-65 years old;
ASA I-III;
Sign the informed consent.

Exclusion Criteria:

Patients with visual impairment;
Patients with severe liver or kidney disease;
Uncontrolled hypertension, diabetes, severe arrhythmia or unstable angina pectoris;
Have mental illness or unable to communicate;
BMI≥30kg/㎡;
Abuse of analgesics and drug abuse history;
Muscle weakness, motor dysfunction or neuromuscular junction disease before operation;
Preoperative somatosensory dysfunction;
Retain trachea catheter after operation;
Narcotic drugs and silicone allergy;
Visual evoked potential monitoring was rejected.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Tiantan Hospital, Capital Medical University	Beijing		China	100070

Sponsors and Collaborators

Beijing Tiantan Hospital

Investigators

Principal Investigator: Ruquan Han, Beijing Tiantan Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ruquan Han, Professor, Beijing Tiantan Hospital

ClinicalTrials.gov Identifier:

NCT05617690

Other Study ID Numbers:

mjj20221108

First Posted:

Nov 15, 2022

Last Update Posted:

Nov 15, 2022

Last Verified:

Nov 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Propofol

Study Results

No Results Posted as of Nov 15, 2022