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

Not Applicable

Completed

• Conditions: Visual Evoked Potentials
• Interventions: Drug: Desflurane; Drug: Desflurane, Propofol

• Registration Number: NCT05465330
• Lead Sponsor: Beijing Tiantan Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-15
• Study First Submitted QC: 2022-07-15
• Study First Posted: 2022-07-19
• Study Start: 2022-07-20
• Primary Completion: 2023-04-21
• Study Completion: 2023-04-21
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-21
• Last Update Posted: 2025-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Desflurane Inhalational group (DR group)	Desflurane	-
Desflurane propofol balanced anesthesia group (DPR group)	Desflurane, Propofol	-

Primary Outcome Measures

Name	Time	Method
N75-p100 amplitude value	60 minutes after anesthesia induction	Wave amplitude difference between N75-P100 peak and trough

Secondary Outcome Measures

Name	Time	Method
N75-P100 amplitude decline rates	30minutes and 60 minutes after anesthesia induction	The decrease rate of wave amplitude of P100-N145 under corresponding anesthesia maintenance methods compared to the baseline measurements under total intravenous anesthesia
Intraoperative vasoactive drugs dosage	The time period between the patient entering the operating room and leaving the operating room	The total amount of norepinephrine, ephedrine, perdipine, and atropine used during surgery
P100-N145 amplitude decline rates	30minutes and 60 minutes after anesthesia induction	The decrease rate of wave amplitude of P100-N145 under corresponding anesthesia maintenance methods compared to the baseline measurements under total intravenous anesthesia
Success rate of FVEP monitoring	30minutes and 60 minutes after anesthesia induction	The number of individuals obtaining satisfactory FVEP monitoring waveforms as a ratio to the total number of individuals monitored in each group
P100 latency prolongation rate	30minutes and 60 minutes after anesthesia induction	The rate of prolongation of P100 latency compared to the baseline measurements under total intravenous anesthesia
FVEPs stacking satisfaction	Intraoperative	Assessed by the electrophysiological monitoring physician, if good waveforms can be obtained with no more than three superimpositions, it is considered satisfactory
Respiratory recovery time	Within 60 minutes after surgery	The time from the cessation of anesthesia to the patient's spontaneous breathing recovery
Eye-opening time	Within 60 minutes after surgery	The time from anesthesia cessation to when the patient can be called to open their eyes
Extubation time	Within 60 minutes after surgery	The time from the cessation of anesthesia to the removal of the patient's tracheal catheter
Postextubation agitation score	Immediately after extubation, 15 minutes after extubation, 30 minutes after extubation, 1 hour after extubation.	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.
Intraoperative anesthetic drugs dosage	The time period between the patient entering the operating room and leaving the operating room	Including the total amount of intraoperative application of sufentanil, remifentanil, propofol, and rocuronium
Ramsay Sedation Score	Immediately after extubation, 15 minutes after extubation, 30 minutes after extubation, 1 hour after extubation.	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.

Trial Locations

Locations (1)

Beijing Tiantan Hospital; 🇨🇳 Beijing, China