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

NCT04725032 | Recruiting

• 1 other identifier: HX-A-023(2020)
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Tumor Adult

Outcome Measures

Primary Outcomes (1)

• N2 amplitudes of FVEPs

  N145-P100 of FVEPs wave

  90min after anesthesia induction

Secondary Outcomes (4)

• P100 latencies of FVEPs

  30, 60 and 90min after anesthesia induction

• The visual acuity

  The day before surgery, and one day after operation.

• The visual field

  The day before surgery, and one day after operation.

• N2 amplitudes of FVEPs

  30 and 60 after anesthesia induction

Study Arms (2)

sevoflurane-propofol balanced anesthesia

EXPERIMENTAL

Drug: Sevoflurane

propofol-based total intravenous anesthesia

ACTIVE COMPARATOR

Drug: Propofol

Interventions

Propofol DRUG

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.

propofol-based total intravenous anesthesia

Sevoflurane DRUG

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.

sevoflurane-propofol balanced anesthesia

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years;
• ASA I-III;
• Elective sellar or parasellar tumors resection;
• Informed written consent

You may not qualify if:

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

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

RECRUITING

MeSH Terms

Interventions

Propofol; Sevoflurane

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Officials

• Ruquan Han, M.D., Ph. D

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruquan Han, M.D., Ph. D

CONTACT

+861059976660; ruquan.han@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 26, 2021
• Study Start: January 25, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 30, 2025
• Last Updated: February 6, 2024

Record last verified: 2024-02

Locations

CN (1)