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

NCT05465330 | Completed

• 1 other identifier: wj20220715
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Visual Evoked Potentials

Outcome Measures

Primary Outcomes (1)

• N75-p100 amplitude value

  Wave amplitude difference between N75-P100 peak and trough

  60 minutes after anesthesia induction

Secondary Outcomes (12)

• N75-P100 amplitude decline rates

  30minutes and 60 minutes after anesthesia induction

• P100-N145 amplitude decline rates

  30minutes and 60 minutes after anesthesia induction

• P100 latency prolongation rate

  30minutes and 60 minutes after anesthesia induction

• Success rate of FVEP monitoring

  30minutes and 60 minutes after anesthesia induction

• FVEPs stacking satisfaction

  Intraoperative

Study Arms (2)

Desflurane Inhalational group (DR group)

EXPERIMENTAL

Drug: Desflurane

Desflurane propofol balanced anesthesia group (DPR group)

ACTIVE COMPARATOR

Drug: Desflurane, Propofol

Interventions

Desflurane DRUG

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

Desflurane Inhalational group (DR group)

Desflurane, Propofol DRUG

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

Desflurane propofol balanced anesthesia group (DPR group)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing spinal cord surgery under elective general anesthesia;
• At the same time, other electrophysiological monitoring is required;
• years old;
• ASA I-III;
• Sign the informed consent form.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, 100070, China

Location

Related Publications (1)

• Ma J, Wang J, Li Y, Fu Y, Li Y, Qiao H, Han R. Effect of desflurane anesthesia on flash visual evoked potential monitoring in patients undergoing spine surgery: study protocol for a randomized controlled trial. Trials. 2024 Jun 6;25(1):362. doi: 10.1186/s13063-024-08211-9.

  PMID: 38840210 DERIVED

MeSH Terms

Interventions

Desflurane; Propofol

Intervention Hierarchy (Ancestors)

Ethyl Ethers; Ethers; Organic Chemicals; Methyl Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 15, 2022
• First Posted: July 19, 2022
• Study Start: July 20, 2022
• Primary Completion: April 21, 2023
• Study Completion: April 21, 2023
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)