Clinical trial NCT05465330: Effects of Desflurane-propofol Balanced Anesthesia on Visual Evoked Potentials Monitoring
Official title: Effects of Desflurane-propofol Balanced Anesthesia on Visual Evoked Potentials Monitoring: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Evoked Potentials
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2022-07-19
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: N75-p100 amplitude value
timeFrame: 60 minutes after anesthesia induction
Secondary outcomes:
measure: N75-P100 amplitude decline rates
timeFrame: 30minutes and 60 minutes after anesthesia induction
measure: P100-N145 amplitude decline rates
timeFrame: 30minutes and 60 minutes after anesthesia induction
measure: P100 latency prolongation rate
timeFrame: 30minutes and 60 minutes after anesthesia induction
measure: Success rate of FVEP monitoring
timeFrame: 30minutes and 60 minutes after anesthesia induction
measure: FVEPs stacking satisfaction
timeFrame: Intraoperative
measure: Respiratory recovery time
timeFrame: Within 60 minutes after surgery
measure: Eye-opening time
timeFrame: Within 60 minutes after surgery
measure: Extubation time
timeFrame: Within 60 minutes after surgery
measure: Postextubation agitation score
timeFrame: Immediately after extubation, 15 minutes after extubation, 30 minutes after extubation, 1 hour after extubation.
measure: Ramsay Sedation Score
timeFrame: Immediately after extubation, 15 minutes after extubation, 30 minutes after extubation, 1 hour after extubation.
measure: Intraoperative anesthetic drugs dosage
timeFrame: The time period between the patient entering the operating room and leaving the operating room
measure: Intraoperative vasoactive drugs dosage
timeFrame: The time period between the patient entering the operating room and leaving the operating room
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
Study officials:
References: