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

Not Applicable

Recruiting

• Conditions: Brain Tumor Adult
• Interventions: Drug: Sevoflurane; Drug: Propofol

• Registration Number: NCT04725032
• Lead Sponsor: Beijing Tiantan Hospital

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.

Study Timeline

• Study First Submitted: 2021-01-14
• Study First Submitted QC: 2021-01-21
• Study Start: 2021-01-25
• Study First Posted: 2021-01-26
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-03
• Last Update Posted: 2024-02-06
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sevoflurane-propofol balanced anesthesia	Sevoflurane	-
propofol-based total intravenous anesthesia	Propofol	-

Primary Outcome Measures

Name	Time	Method
N2 amplitudes of FVEPs	90min after anesthesia induction	N145-P100 of FVEPs wave

Secondary Outcome Measures

Name	Time	Method
N2 amplitudes of FVEPs	30 and 60 after anesthesia induction	N145-P100 of FVEPs wave
P100 latencies of FVEPs	30, 60 and 90min after anesthesia induction	P100 latencies of FVEPs wave
The visual acuity	The day before surgery, and one day after operation.	The visual acuity before and after operation.
The visual field	The day before surgery, and one day after operation.	The field of patients before and after operation.

Trial Locations

Locations (1)

Beijing Tiantan Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China