Skip to content

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05465330
Enrollment
70
Registered
2022-07-19
Start date
2022-07-20
Completion date
2023-04-21
Last updated
2025-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Visual Evoked Potentials

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.

Interventions

DRUGDesflurane

After induction, anesthesia will be maintained with 0.7-1.0 MAC desflurane and remifentanil 0.05-0.2 μg/kg/min

DRUGDesflurane, 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

Sponsors

Beijing Tiantan Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
N75-p100 amplitude value60 minutes after anesthesia inductionWave amplitude difference between N75-P100 peak and trough

Secondary

MeasureTime frameDescription
P100-N145 amplitude decline rates30minutes and 60 minutes after anesthesia inductionThe decrease rate of wave amplitude of P100-N145 under corresponding anesthesia maintenance methods compared to the baseline measurements under total intravenous anesthesia
P100 latency prolongation rate30minutes and 60 minutes after anesthesia inductionThe rate of prolongation of P100 latency compared to the baseline measurements under total intravenous anesthesia
Success rate of FVEP monitoring30minutes and 60 minutes after anesthesia inductionThe number of individuals obtaining satisfactory FVEP monitoring waveforms as a ratio to the total number of individuals monitored in each group
FVEPs stacking satisfactionIntraoperativeAssessed by the electrophysiological monitoring physician, if good waveforms can be obtained with no more than three superimpositions, it is considered satisfactory
Respiratory recovery timeWithin 60 minutes after surgeryThe time from the cessation of anesthesia to the patient's spontaneous breathing recovery
N75-P100 amplitude decline rates30minutes and 60 minutes after anesthesia inductionThe decrease rate of wave amplitude of P100-N145 under corresponding anesthesia maintenance methods compared to the baseline measurements under total intravenous anesthesia
Extubation timeWithin 60 minutes after surgeryThe time from the cessation of anesthesia to the removal of the patient's tracheal catheter
Postextubation agitation scoreImmediately 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.
Ramsay Sedation ScoreImmediately 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.
Intraoperative anesthetic drugs dosageThe time period between the patient entering the operating room and leaving the operating roomIncluding the total amount of intraoperative application of sufentanil, remifentanil, propofol, and rocuronium
Intraoperative vasoactive drugs dosageThe time period between the patient entering the operating room and leaving the operating roomThe total amount of norepinephrine, ephedrine, perdipine, and atropine used during surgery
Eye-opening timeWithin 60 minutes after surgeryThe time from anesthesia cessation to when the patient can be called to open their eyes

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026