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

September 12, 2023 updated by: Ruquan Han, Beijing Tiantan Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

148

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China, 100070
        • Recruiting
        • Beijing Tiantan Hospital, Capital Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
N75-p100 amplitude of FVEP
Time Frame: Intraoperative
Intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tiantan Hospital

Investigators

  • Principal Investigator: Ruquan Han, Beijing Tiantan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

November 8, 2022

First Submitted That Met QC Criteria

November 8, 2022

First Posted (Actual)

November 15, 2022

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 12, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • mjj20221108

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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