Effects of Desflurane-propofol Balanced Anesthesia on Visual Evoked Potentials Monitoring: a Randomized Controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- N75-p100 amplitude value
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients undergoing spinal cord surgery under elective general anesthesia;
- •At the same time, other electrophysiological monitoring is required;
- •18-65 years old;
- •Sign the informed consent form.
Exclusion Criteria
- •Patients with visual impairment;
- •Patients with severe liver and kidney function diseases;
- •History of asthma; Uncontrolled hypertension, diabetes, severe arrhythmia or unstable angina pectoris;
- •Have mental illness or unable to communicate;
- •BMI≥30kg/m2；
- •Abuse of analgesics and drug abuse history;
- •Silicone allergy;
- •Visual evoked potential monitoring was rejected.
Arms & Interventions
Desflurane Inhalational group (DR group)
Intervention: Desflurane (Drug)
Desflurane propofol balanced anesthesia group (DPR group)
Intervention: Desflurane, Propofol (Drug)
Outcomes
Primary Outcomes
N75-p100 amplitude value
Time Frame: 60 minutes after anesthesia induction
Wave amplitude difference between N75-P100 peak and trough
Secondary Outcomes
- Intraoperative vasoactive drugs dosage(The time period between the patient entering the operating room and leaving the operating room)
- N75-P100 amplitude decline rates(30minutes and 60 minutes after anesthesia induction)
- P100-N145 amplitude decline rates(30minutes and 60 minutes after anesthesia induction)
- Success rate of FVEP monitoring(30minutes and 60 minutes after anesthesia induction)
- P100 latency prolongation rate(30minutes and 60 minutes after anesthesia induction)
- FVEPs stacking satisfaction(Intraoperative)
- Respiratory recovery time(Within 60 minutes after surgery)
- Eye-opening time(Within 60 minutes after surgery)
- Extubation time(Within 60 minutes after surgery)
- Postextubation agitation score(Immediately after extubation, 15 minutes after extubation, 30 minutes after extubation, 1 hour after extubation.)
- Intraoperative anesthetic drugs dosage(The time period between the patient entering the operating room and leaving the operating room)
- Ramsay Sedation Score(Immediately after extubation, 15 minutes after extubation, 30 minutes after extubation, 1 hour after extubation.)
Investigators
Ruquan Han
Professor
Beijing Tiantan Hospital