- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04725032
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
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
-
-
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
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18-65 years;
- ASA I-III;
- Elective sellar or parasellar tumors resection;
- Informed written consent
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: sevoflurane-propofol balanced anesthesia
|
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
|
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
Time Frame: 90min after anesthesia induction
|
N145-P100 of FVEPs wave
|
90min after anesthesia induction
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
P100 latencies of FVEPs
Time Frame: 30, 60 and 90min after anesthesia induction
|
P100 latencies of FVEPs wave
|
30, 60 and 90min after anesthesia induction
|
The visual acuity
Time Frame: The day before surgery, and one day after operation.
|
The visual acuity before and after operation.
|
The day before surgery, and one day after operation.
|
The visual field
Time Frame: The day before surgery, and one day after operation.
|
The field of patients before and after operation.
|
The day before surgery, and one day after operation.
|
N2 amplitudes of FVEPs
Time Frame: 30 and 60 after anesthesia induction
|
N145-P100 of FVEPs wave
|
30 and 60 after anesthesia induction
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ruquan Han, M.D., Ph. D, Beijing Tiantan Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HX-A-023(2020)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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