Brain Tumor AdultNCT04725032
Effects of Intravenous Anesthesia and Balanced Anesthesia on Flash Visual Evoked Potentials
A study testing Propofol and Sevoflurane in people with Brain Tumor Adult, run by Beijing Tiantan Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Brain Tumor Adult
- What is being tested?
- Propofol and Sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 25 Jan 2021to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years;
- ASA I-III;
- Elective sellar or parasellar tumors resection;
- Informed written consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
Ruquan Han, M.D., Ph.D, 8610-59976660, ruquan.han@gmail.com
Ruquan Han, M.D., Ph.D
About this study
Official title: 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.
Read the 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.
- Conditions
- Brain Tumor Adult
- Being tested
- Propofol, Sevoflurane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
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.
SevofluraneDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| sevoflurane-propofol balanced anesthesia | Experimental | Not described Receives: Drug: Sevoflurane |
| propofol-based total intravenous anesthesia | Active comparator | Not described Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
N2 amplitudes of FVEPs
N145-P100 of FVEPs wave
Measured: 90min after anesthesia induction
Secondary outcomes (4)
P100 latencies of FVEPs
P100 latencies of FVEPs wave
Measured: 30, 60 and 90min after anesthesia induction
The visual acuity
The visual acuity before and after operation.
Measured: The day before surgery, and one day after operation.
The visual field
The field of patients before and after operation.
Measured: The day before surgery, and one day after operation.
N2 amplitudes of FVEPs
N145-P100 of FVEPs wave
Measured: 30 and 60 after anesthesia induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start25 Jan 2021
- Primary completion1 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Tumor AdultStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruquan Han, Beijing Tiantan Hospital
- Investigators
- Ruquan Han, M.D., Ph. D, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04725032
- Sponsor's protocol ID
- HX-A-023(2020)
- Status last verified
- Feb 2024
- First submitted
- 14 Jan 2021
- Last updated
- 6 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Enrolled subjects will be assigned a subject identification number
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Total Intravenous Anesthesia and Balanced General Anesthesia on Flash Visual Evoked Potential Monitoring During Sellar Tumors Resection
- ClinicalTrials.gov ID
- NCT04725032
- Acronym / sponsor ID
- HX-A-023(2020)
- Conditions
- Brain Tumor Adult
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 26 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sevoflurane-propofol balanced anesthesia | Experimental | Drug: Sevoflurane |
| propofol-based total intravenous anesthesia | Active comparator | Drug: Propofol |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-65 years;
- ASA I-III;
- Elective sellar or parasellar tumors resection;
- Informed written consent
Key exclusion criteria (6 listed)
- Preoperative visual acuity<0.3;
- BMI>30kg/cm2;
- Uncontrolled hypertension, diabetes or cardiac diseases;
- Preoperative cognitive disorders;
- Sedatives, alcohol or analgesic addiction history;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropofolPropofol 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 | propofol-based total intravenous anesthesia |
| SevofluraneBalanced 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. | Drug | sevoflurane-propofol balanced anesthesia |
Primary outcome
N2 amplitudes of FVEPs
Time frame: 90min after anesthesia induction
N145-P100 of FVEPs wave
4 secondary outcomes
P100 latencies of FVEPs
Time frame: 30, 60 and 90min after anesthesia induction
The visual acuity
Time frame: The day before surgery, and one day after operation.
The visual field
Time frame: The day before surgery, and one day after operation.
N2 amplitudes of FVEPs
Time frame: 30 and 60 after anesthesia induction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Individual participant dataSharing planned: Undecided. Enrolled subjects will be assigned a subject identification number
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruquan Han, M.D., Ph. D principal investigator
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol and Sevoflurane in people with Brain Tumor Adult, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruquan Han, M.D., Ph. D (+861059976660, ruquan.han@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
N2 amplitudes of FVEPs (time frame: 90min after anesthesia induction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.