Effects of Desflurane-propofol Balanced Anesthesia on Visual Evoked Potentials Monitoring

Effects of Desflurane-propofol Balanced Anesthesia on Visual Evoked Potentials Monitoring: a Randomized Controlled Study

Intraoperative flash visual evoked potentials (FVEPs) can be used to monitor the integrity of the visual pathway in real-time during surgeries, and is to prevent the damage and deterioration of visual function caused by visual pathway damage, which is the key method of intraoperative monitoring of visual function.

Spinal surgery in the prone position may compress the eyeball and reduce the blood supply of the ophthalmic artery, which is still one of the main causes of postoperative visual impairment. Intraoperative FVEPs monitoring is easily affected by inhale anesthetics, and there is little studies on the effect of intravenous-inhalation balanced anesthesia on FVEPs monitoring. Desflurane wakes up quickly, which is conducive to the recovery of early respiratory function and orientation, and early neurological evaluation. This study aims to compare the effects of desflurane-propofol balanced anesthesia and desflurane pure inhalation anesthesia on the amplitude and latency of FVEPs during spinal surgery under the same sedation depth monitored by bispectral index (BIS) monitoring.

Study Overview

• Status: Completed
• Conditions: Visual Evoked Potentials
• Intervention / Treatment: Drug: Desflurane; Drug: Desflurane, Propofol

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100070
    • Beijing Tiantan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients undergoing spinal cord surgery under elective general anesthesia;
2. At the same time, other electrophysiological monitoring is required;
3. 18-65 years old;
4. ASA I-III;
5. Sign the informed consent form.

Exclusion Criteria:

1. Patients with visual impairment;
2. Patients with severe liver and kidney function diseases;
3. History of asthma; Uncontrolled hypertension, diabetes, severe arrhythmia or unstable angina pectoris;
4. Have mental illness or unable to communicate;
5. BMI≥30kg/m2；
6. Abuse of analgesics and drug abuse history;
7. Silicone allergy;
8. Visual evoked potential monitoring was rejected.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Desflurane Inhalational group (DR group)	Drug: Desflurane; After induction, anesthesia will be maintained with 0.7-1.0 MAC desflurane and remifentanil 0.05-0.2 μg/kg/min
Active Comparator: Desflurane propofol balanced anesthesia group (DPR group)	Drug: Desflurane, Propofol; After induction, anesthesia will be maintained with 0.5 MAC desflurane, propofol 1.5-2.5 μg/ml and remifentanil 0.05-0.2 μg/kg/min

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
N75-p100 amplitude value	Wave amplitude difference between N75-P100 peak and trough	60 minutes after anesthesia induction

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
N75-P100 amplitude decline rates	The decrease rate of wave amplitude of P100-N145 under corresponding anesthesia maintenance methods compared to the baseline measurements under total intravenous anesthesia	30minutes and 60 minutes after anesthesia induction
P100-N145 amplitude decline rates	The decrease rate of wave amplitude of P100-N145 under corresponding anesthesia maintenance methods compared to the baseline measurements under total intravenous anesthesia	30minutes and 60 minutes after anesthesia induction
P100 latency prolongation rate	The rate of prolongation of P100 latency compared to the baseline measurements under total intravenous anesthesia	30minutes and 60 minutes after anesthesia induction
Success rate of FVEP monitoring	The number of individuals obtaining satisfactory FVEP monitoring waveforms as a ratio to the total number of individuals monitored in each group	30minutes and 60 minutes after anesthesia induction
FVEPs stacking satisfaction	Assessed by the electrophysiological monitoring physician, if good waveforms can be obtained with no more than three superimpositions, it is considered satisfactory	Intraoperative
Respiratory recovery time	The time from the cessation of anesthesia to the patient's spontaneous breathing recovery	Within 60 minutes after surgery
Eye-opening time	The time from anesthesia cessation to when the patient can be called to open their eyes	Within 60 minutes after surgery
Extubation time	The time from the cessation of anesthesia to the removal of the patient's tracheal catheter	Within 60 minutes after surgery
Postextubation agitation score	1 point, calm sleep; 2 points, awake and calm; 3 points, irritable, easily agitated, crying; 4 points, difficult to console, uncontrollable crying; 5 points, unable to settle, confused, delirious.	Immediately after extubation, 15 minutes after extubation, 30 minutes after extubation, 1 hour after extubation.
Ramsay Sedation Score	1 point - awake, anxious, and restless; 2 points - cooperative, oriented, and calm; 3 points - drowsy, responds to commands; 4 points - drowsy, responds promptly to light tapping on the forehead or loud auditory stimulation; 5 points - drowsy, responds sluggishly to light tapping on the forehead or loud auditory stimulation; 6 points - drowsy, unresponsive. Sedation is considered satisfactory with a score of 2-4, and excessive sedation with a score of 5-6.	Immediately after extubation, 15 minutes after extubation, 30 minutes after extubation, 1 hour after extubation.
Intraoperative anesthetic drugs dosage	Including the total amount of intraoperative application of sufentanil, remifentanil, propofol, and rocuronium	The time period between the patient entering the operating room and leaving the operating room
Intraoperative vasoactive drugs dosage	The total amount of norepinephrine, ephedrine, perdipine, and atropine used during surgery	The time period between the patient entering the operating room and leaving the operating room

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2022
• Primary Completion (Actual): April 21, 2023
• Study Completion (Actual): April 21, 2023

Study Registration Dates

• First Submitted: July 15, 2022
• First Submitted That Met QC Criteria: July 15, 2022
• First Posted (Actual): July 19, 2022

Study Record Updates

• Last Update Posted (Actual): April 24, 2025
• Last Update Submitted That Met QC Criteria: April 21, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anesthetics; Central Nervous System Depressants; Hypnotics and Sedatives; Anesthetics, Intravenous; Anesthetics, General; Anesthetics, Inhalation; Desflurane; Propofol
• Other Study ID Numbers: wj20220715

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No