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Effects of Intravenous Anesthesia and Balanced Anesthesia on Flash Visual Evoked Potentials

Comparison of the Effects of Total Intravenous Anesthesia and Balanced General Anesthesia on Flash Visual Evoked Potential Monitoring During Sellar Tumors Resection

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04725032
Enrollment
84
Registered
2021-01-26
Start date
2021-01-25
Completion date
2025-12-30
Last updated
2024-02-06

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

Conditions

Brain Tumor Adult

Brief summary

Intraoperative flash visual evoked potentials (FVEPs) could monitor visual function during neurosurgery. There are fewer reports comparing the effects of sevoflurane-propofol balanced anesthesia and propofol-based total intravenous anesthesia under comparable bispectral index (BIS) levels on the amplitude and latency of flash visual evoked potentials (FVEPs) for sellar or parasellar tumors resection neurosurgeries.

Detailed description

The overall incidence rate of sellar tumors is 10-20% of brain tumors. Most of the initial symptoms of this tumor are visual or visual impairment. One of the primary complications of these operations is visual impairment, which directly relates to the quality of patients' life. Flash visual evoked potentials (FVEPs) is an important means of intraoperative visual function evaluation under general anesthesia. Intraoperative visual function damage can be avoided or reduced by observing the changing of FVEPs waves to guide the choice of surgical path. However, since the diversity of anesthetic drugs and methods, there is still a great uncertainty impact on FVEPs, which will interfere with the interpretation and judgment of surgeons and neuroelectrophysiological physicians respect to the changes of FVEPs amplitude and latency, and further affect the operation decision-making. Therefore, it is urgent to establish a perfect anesthesia method for intraoperative monitoring of FVEPs. Although total intravenous anesthesia has been widely accepted for FVEPs monitoring, there are still some limitations, such as the possibility of intraoperative body movement and cough due to the restriction of muscle relaxant use under electrophysiological monitoring, as well as the depression on FVEPs of high maintained dosage under total intravenous anesthesia. The purpose of this study was to investigate the feasibility of FVEPs monitoring during endoscopic sellar tumor resection under combined intravenous anesthesia compared with total intravenous anesthesia.

Interventions

DRUGPropofol

Propofol will be administered for anesthesia maintenance in patients randomized to the propofol-based TIVA arm of the study. In order to record the VEPs, standard spiral electrodes or subcutaneous electrodes will be inserted subcutaneously around the visual area and the Nicolet Viking IV System will be used to monitor VEP during surgery.

DRUGSevoflurane

Balanced general anesthesia with sevoflurane will be administered for anesthesia maintenance in patients randomized to the balanced general anesthesia arm of the study. In order to record the VEPs, standard spiral electrodes or subcutaneous electrodes will be inserted subcutaneously around the visual area and the Nicolet Viking IV System will be used to monitor VEP during surgery.

Sponsors

Beijing Tiantan Hospital
Lead SponsorOTHER

Study design

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

Eligibility

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

Inclusion criteria

1. Age 18-65 years; 2. ASA I-III; 3. Elective sellar or parasellar tumors resection; 4. Informed written consent

Exclusion criteria

1. Preoperative visual acuity\<0.3; 2. BMI\>30kg/cm2; 3. Uncontrolled hypertension, diabetes or cardiac diseases; 4. Preoperative cognitive disorders; 5. Sedatives, alcohol or analgesic addiction history; 6. Allergy to drugs of this study or contact allergy to Silicone products

Design outcomes

Primary

MeasureTime frameDescription
N2 amplitudes of FVEPs90min after anesthesia inductionN145-P100 of FVEPs wave

Secondary

MeasureTime frameDescription
P100 latencies of FVEPs30, 60 and 90min after anesthesia inductionP100 latencies of FVEPs wave
The visual acuityThe day before surgery, and one day after operation.The visual acuity before and after operation.
The visual fieldThe day before surgery, and one day after operation.The field of patients before and after operation.
N2 amplitudes of FVEPs30 and 60 after anesthesia inductionN145-P100 of FVEPs wave

Countries

China

Contacts

Primary ContactRuquan Han, M.D., Ph. D
ruquan.han@gmail.com+861059976660

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026