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

NCT ID: NCT05465330

Last Updated: 2025-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-20

Study Completion Date

2023-04-21

Brief Summary

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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

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Conditions

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Visual Evoked Potentials

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Desflurane Inhalational group (DR group)

Group Type EXPERIMENTAL

Desflurane

Intervention Type DRUG

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

Desflurane propofol balanced anesthesia group (DPR group)

Group Type ACTIVE_COMPARATOR

Desflurane, Propofol

Intervention Type 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

Interventions

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Desflurane

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

Intervention Type DRUG

Desflurane, 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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tiantan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ruquan Han

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beijing Tiantan Hospital

Beijing, , China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 38840210 (View on PubMed)

Other Identifiers

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wj20220715

Identifier Type: -

Identifier Source: org_study_id

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