Visual Evoked PotentialsNCT05465330
Effects of Desflurane-propofol Balanced Anesthesia on Visual Evoked Potentials Monitoring
A study testing Desflurane and Desflurane, Propofol in people with Visual Evoked Potentials, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
Intraoperative flash visual evoked potentials (FVEPs) can be used to monitor the integrity of the visual pathway in real-time during surgeries, and is to prevent the damage and deterioration of visual function caused by visual pathway damage, which is the key method of intraoperative monitoring of visual function. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Visual Evoked Potentials
- What is being tested?
- Desflurane and Desflurane, Propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2022to 21 Apr 2023
- 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
- Patients undergoing spinal cord surgery under elective general anesthesia;
- At the same time, other electrophysiological monitoring is required;
- 18-65 years old;
- ASA I-III;
- Sign the informed consent form.
Who cannot join
- Patients with visual impairment;
- Patients with severe liver and kidney function diseases;
- History of asthma; Uncontrolled hypertension, diabetes, severe arrhythmia or unstable angina pectoris;
- Have mental illness or unable to communicate;
- BMI≥30kg/m2；
- Abuse of analgesics and drug abuse history;
- Silicone allergy;
- Visual evoked potential monitoring was rejected.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Desflurane-propofol Balanced Anesthesia on Visual Evoked Potentials Monitoring: a Randomized Controlled Study
Intraoperative flash visual evoked potentials (FVEPs) can be used to monitor the integrity of the visual pathway in real-time during surgeries, and is to prevent the damage and deterioration of visual function caused by visual pathway damage, which is the key method of intraoperative monitoring of visual function.
Spinal surgery in the prone position may compress the eyeball and reduce the blood supply of the ophthalmic artery, which is still one of the main causes of postoperative visual impairment. Intraoperative FVEPs monitoring is easily affected by inhale anesthetics, and there is little studies on the effect of intravenous-inhalation balanced anesthesia on FVEPs monitoring. Desflurane wakes up quickly, which is conducive to the recovery of early respiratory function and orientation, and early neurological evaluation. This study aims to compare the effects of desflurane-propofol balanced anesthesia and desflurane pure inhalation anesthesia on the amplitude and latency of FVEPs during spinal surgery under the same sedation depth monitored by bispectral index (BIS) monitoring.
- Conditions
- Visual Evoked Potentials
- Being tested
- Desflurane, Desflurane, Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesfluraneDrug
After induction, anesthesia will be maintained with 0.7-1.0 MAC desflurane and remifentanil 0.05-0.2 μg/kg/min
Desflurane, PropofolDrug
After induction, anesthesia will be maintained with 0.5 MAC desflurane, propofol 1.5-2.5 μg/ml and remifentanil 0.05-0.2 μg/kg/min
| Study group | Role | What they receive |
|---|---|---|
| Desflurane Inhalational group (DR group) | Experimental | Not described Receives: Drug: Desflurane |
| Desflurane propofol balanced anesthesia group (DPR group) | Active comparator | Not described Receives: Drug: Desflurane, Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
N75-p100 amplitude value
Wave amplitude difference between N75-P100 peak and trough
Measured: 60 minutes after anesthesia induction
Secondary outcomes (12)
N75-P100 amplitude decline rates
The decrease rate of wave amplitude of P100-N145 under corresponding anesthesia maintenance methods compared to the baseline measurements under total intravenous anesthesia
Measured: 30minutes and 60 minutes after anesthesia induction
P100-N145 amplitude decline rates
The decrease rate of wave amplitude of P100-N145 under corresponding anesthesia maintenance methods compared to the baseline measurements under total intravenous anesthesia
Measured: 30minutes and 60 minutes after anesthesia induction
P100 latency prolongation rate
The rate of prolongation of P100 latency compared to the baseline measurements under total intravenous anesthesia
Measured: 30minutes and 60 minutes after anesthesia induction
Success rate of FVEP monitoring
The number of individuals obtaining satisfactory FVEP monitoring waveforms as a ratio to the total number of individuals monitored in each group
Measured: 30minutes and 60 minutes after anesthesia induction
FVEPs stacking satisfaction
Assessed by the electrophysiological monitoring physician, if good waveforms can be obtained with no more than three superimpositions, it is considered satisfactory
Measured: Intraoperative
Respiratory recovery time
The time from the cessation of anesthesia to the patient's spontaneous breathing recovery
Measured: Within 60 minutes after surgery
Eye-opening time
The time from anesthesia cessation to when the patient can be called to open their eyes
Measured: Within 60 minutes after surgery
Extubation time
The time from the cessation of anesthesia to the removal of the patient's tracheal catheter
Measured: Within 60 minutes after surgery
Postextubation agitation score
1 point, calm sleep; 2 points, awake and calm; 3 points, irritable, easily agitated, crying; 4 points, difficult to console, uncontrollable crying; 5 points, unable to settle, confused, delirious.
Measured: Immediately after extubation, 15 minutes after extubation, 30 minutes after extubation, 1 hour after extubation.
Ramsay Sedation Score
1 point - awake, anxious, and restless; 2 points - cooperative, oriented, and calm; 3 points - drowsy, responds to commands; 4 points - drowsy, responds promptly to light tapping on the forehead or loud auditory stimulation; 5 points - drowsy, responds sluggishly to light tapping on the forehead or loud auditory stimulation; 6 points - drowsy, unresponsive. Sedation is considered satisfactory with a score of 2-4, and excessive sedation with a score of 5-6.
Measured: Immediately after extubation, 15 minutes after extubation, 30 minutes after extubation, 1 hour after extubation.
Intraoperative anesthetic drugs dosage
Including the total amount of intraoperative application of sufentanil, remifentanil, propofol, and rocuronium
Measured: The time period between the patient entering the operating room and leaving the operating room
Intraoperative vasoactive drugs dosage
The total amount of norepinephrine, ephedrine, perdipine, and atropine used during surgery
Measured: The time period between the patient entering the operating room and leaving the operating room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start20 Jul 2022
- Primary completion21 Apr 2023
- Study completion21 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Visual Evoked PotentialsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruquan Han, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05465330
- Sponsor's protocol ID
- wj20220715
- Status last verified
- Apr 2025
- First submitted
- 15 Jul 2022
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ma J, Wang J, Li Y, Fu Y, Li Y, Qiao H, Han R. Effect of desflurane anesthesia on flash visual evoked potential monitoring in patients undergoing spine surgery: study protocol for a randomized controlled trial. Trials. 2024 Jun 6;25(1):362. doi: 10.1186/s13063-024-08211-9.
PubMed 38840210
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Desflurane-propofol Balanced Anesthesia on Visual Evoked Potentials Monitoring: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05465330
- Acronym / sponsor ID
- wj20220715
- Conditions
- Visual Evoked Potentials
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 20 Jul 2022 (actual)
- Primary completion
- 21 Apr 2023 (actual)
- Study completion
- 21 Apr 2023 (actual)
- First posted
- 19 Jul 2022 (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) can be used to monitor the integrity of the visual pathway in real-time during surgeries, and is to prevent the damage and deterioration of visual function caused by visual pathway damage, which is the key method of intraoperative monitoring of visual function.
Spinal surgery in the prone position may compress the eyeball and reduce the blood supply of the ophthalmic artery, which is still one of the main causes of postoperative visual impairment. Intraoperative FVEPs monitoring is easily affected by inhale anesthetics, and there is little studies on the effect of intravenous-inhalation balanced anesthesia on FVEPs monitoring. Desflurane wakes up quickly, which is conducive to the recovery of early respiratory function and orientation, and early neurological evaluation. This study aims to compare the effects of desflurane-propofol balanced anesthesia and desflurane pure inhalation anesthesia on the amplitude and latency of FVEPs during spinal surgery under the same sedation depth monitored by bispectral index (BIS) monitoring.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Desflurane Inhalational group (DR group) | Experimental | Drug: Desflurane |
| Desflurane propofol balanced anesthesia group (DPR group) | Active comparator | Drug: Desflurane, Propofol |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients undergoing spinal cord surgery under elective general anesthesia;
- At the same time, other electrophysiological monitoring is required;
- 18-65 years old;
- ASA I-III;
- Sign the informed consent form.
Key exclusion criteria (8 listed)
- Patients with visual impairment;
- Patients with severe liver and kidney function diseases;
- History of asthma; Uncontrolled hypertension, diabetes, severe arrhythmia or unstable angina pectoris;
- Have mental illness or unable to communicate;
- BMI≥30kg/m2；
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 |
|---|---|---|
| DesfluraneAfter induction, anesthesia will be maintained with 0.7-1.0 MAC desflurane and remifentanil 0.05-0.2 μg/kg/min | Drug | Desflurane Inhalational group (DR group) |
| Desflurane, PropofolAfter induction, anesthesia will be maintained with 0.5 MAC desflurane, propofol 1.5-2.5 μg/ml and remifentanil 0.05-0.2 μg/kg/min | Drug | Desflurane propofol balanced anesthesia group (DPR group) |
Primary outcome
N75-p100 amplitude value
Time frame: 60 minutes after anesthesia induction
Wave amplitude difference between N75-P100 peak and trough
12 secondary outcomes
N75-P100 amplitude decline rates
Time frame: 30minutes and 60 minutes after anesthesia induction
P100-N145 amplitude decline rates
Time frame: 30minutes and 60 minutes after anesthesia induction
P100 latency prolongation rate
Time frame: 30minutes and 60 minutes after anesthesia induction
Success rate of FVEP monitoring
Time frame: 30minutes and 60 minutes after anesthesia induction
FVEPs stacking satisfaction
Time frame: Intraoperative
Respiratory recovery time
Time frame: Within 60 minutes after surgery
Eye-opening time
Time frame: Within 60 minutes after surgery
Extubation time
Time frame: Within 60 minutes after surgery
Postextubation agitation score
Time frame: Immediately after extubation, 15 minutes after extubation, 30 minutes after extubation, 1 hour after extubation.
Ramsay Sedation Score
Time frame: Immediately after extubation, 15 minutes after extubation, 30 minutes after extubation, 1 hour after extubation.
Intraoperative anesthetic drugs dosage
Time frame: The time period between the patient entering the operating room and leaving the operating room
Intraoperative vasoactive drugs dosage
Time frame: The time period between the patient entering the operating room and leaving the operating room
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Derived from this study: PubMed 38840210Ma J, Wang J, Li Y, Fu Y, Li Y, Qiao H, Han R. Effect of desflurane anesthesia on flash visual evoked potential monitoring in patients undergoing spine surgery: study protocol for a randomized controlled trial. Trials. 2024 Jun 6;25(1):362. doi: 10.1186/s13063-024-08211-9.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Desflurane and Desflurane, Propofol in people with Visual Evoked Potentials, 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 24 Apr 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
N75-p100 amplitude value (time frame: 60 minutes after anesthesia induction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05465330, which also lists 1 linked publication.
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 24 Apr 2025.