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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 65 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04725032
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Beijing Tiantan Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Ruquan Han, M.D., Ph. D
Principal Investigator Affiliation	Beijing Tiantan Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Brain Tumor Adult

Additional Details

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.

Arms & Interventions

Arms

Experimental: sevoflurane-propofol balanced anesthesia

Active Comparator: propofol-based total intravenous anesthesia

Interventions

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.

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.

Contact a Trial Team

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International Sites

Beijing, Beijing, China

Status

Recruiting

Address

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing, 100070

Site Contact

Ruquan Han, M.D., Ph.D

[email protected]

8610-59976660

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