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

NCT05617690 | Unknown

• 1 other identifier: mjj20221108
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

Visual Evoked Potentials

Outcome Measures

Primary Outcomes (1)

• N75-p100 amplitude of FVEP

  Intraoperative

Study Arms (2)

Cyclopol group

EXPERIMENTAL

Drug: Cyclopol

Propofol group

ACTIVE COMPARATOR

Drug: Propofol

Interventions

Cyclopol 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

Cyclopol group

Propofol 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

Propofol group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, 100070, China

RECRUITING

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Ruquan Han

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiajia Ma

CONTACT

861059976658; majj04@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 8, 2022
• First Posted: November 15, 2022
• Study Start: April 4, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 30, 2024
• Last Updated: September 13, 2023

Record last verified: 2023-09

Locations

CN (1)