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

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.

Study Overview

• Status: Recruiting
• Conditions: Brain Tumor Adult
• Intervention / Treatment: Drug: Sevoflurane; Drug: Propofol

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 Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ruquan Han, M.D., Ph. D; Phone Number: +861059976660; Email: ruquan.han@gmail.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100070
      • Recruiting
      • Beijing Tiantan Hospital, Capital Medical University
      • Contact: Ruquan Han, M.D., Ph.D; Phone Number: 8610-59976660; Email: ruquan.han@gmail.com
      • Principal Investigator: Ruquan Han, M.D., Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: sevoflurane-propofol balanced anesthesia	Drug: Sevoflurane; 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.
Active Comparator: propofol-based total intravenous anesthesia	Drug: Propofol; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
N2 amplitudes of FVEPs	N145-P100 of FVEPs wave	90min after anesthesia induction

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Investigators: Principal Investigator: Ruquan Han, M.D., Ph. D, Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2021
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: January 14, 2021
• First Submitted That Met QC Criteria: January 21, 2021
• First Posted (Actual): January 26, 2021

Study Record Updates

• Last Update Posted (Actual): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 3, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Hypnotics and Sedatives; Anesthetics, Inhalation; Propofol; Sevoflurane
• Other Study ID Numbers: HX-A-023(2020)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Enrolled subjects will be assigned a subject identification number

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No