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

Sponsor
Beijing Tiantan Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04725032
Collaborator
(none)
84
1
2
23.1
3.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
84 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Diagnostic
Official Title:
Comparison of the Effects of Total Intravenous Anesthesia and Balanced General Anesthesia on Flash Visual Evoked Potential Monitoring During Sellar Tumors Resection
Actual Study Start Date :
Jan 25, 2021
Anticipated Primary Completion Date :
Dec 25, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. N2 amplitudes of FVEPs [90min after anesthesia induction]

    N145-P100 of FVEPs wave

Secondary Outcome Measures

  1. P100 latencies of FVEPs [30, 60 and 90min after anesthesia induction]

    P100 latencies of FVEPs wave

  2. The visual acuity [The day before surgery, and one day after operation.]

    The visual acuity before and after operation.

  3. The visual field [The day before surgery, and one day after operation.]

    The field of patients before and after operation.

  4. N2 amplitudes of FVEPs [30 and 60 after anesthesia induction]

    N145-P100 of FVEPs wave

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing Tiantan Hospital, Capital Medical University Beijing Beijing China 100070

Sponsors and Collaborators

  • Beijing Tiantan Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ruquan Han, Professor, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier:
NCT04725032
Other Study ID Numbers:
  • HX-A-023(2020)
First Posted:
Jan 26, 2021
Last Update Posted:
Nov 2, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 2, 2021