CraniotomyNCT06244017
EEG Spectrogram-guided vs. Index-guided Anesthesia for Craniotomy
A study testing EEG spectrogram and Bispectral index in people with Craniotomy, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
In this trial, investigators aimed to compared the clinical effects between the electroencephalographic (EEG) spetrogram-guided and processed EEG index-guided multimodal general anesthesia using the combination of propofol, dexmedetomidine, remifentnil and the scalp block in patients undergoing elective craniotomy. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Craniotomy
- What is being tested?
- EEG spectrogram and Bispectral index
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2024to Feb 2026
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing elective craniotomy
Who cannot join
- revision surgery
- heart failure
- liver cirrhosis > Child B class
- chronic obstructive pulmonary disease
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 300
Chun-Yu Wu, 886976653376
Chun-Yu Wu
About this study
Official title: Comparisons Between Electroencephalographic Spectrogram-guided and Bispectral Index-guided Multimodal General Anesthesia During Craniotomy- a Randomized Controlled Trial
In this trial, investigators aimed to compared the clinical effects between the electroencephalographic (EEG) spetrogram-guided and processed EEG index-guided multimodal general anesthesia using the combination of propofol, dexmedetomidine, remifentnil and the scalp block in patients undergoing elective craniotomy.
Read the detailed description
The multimodal general anesthesia involved the administration of combinations of antinociceptive agents and hypnotics using electroencephalographic (EEG) based monitors to achieve a balanced state of anesthesia. Traditionally, the adjustment of general anesthesia drugs has been done using instruments like the Bispectral Index (BIS), which converts frontal lobe EEG signals into a numerical range of 0-100. This allows anesthesiologists to assess drug dosage and depth of anesthesia. However, numerical conversion may not accurately reflect individual variations and cannot precisely calculate drug concentrations in the case of multiple drug combinations.
For instance, dexmedetomidine (DEX) is currently one of the most commonly used drugs in multimodal generagal anesthesia.Because each anesthetic produces distinct brain states that are readily visible in an EEG density spectral array (DSA) and can be easily interpreted by anesthesiologists, anesthetic titration based on an EEG DSA may provide additional information for anesthetic depth monitoring and may avoid the conventional 'one-index-fits-all' approach, which often ignores the influence of anesthetic drug combination. Theoretically, the anesthetic exposure in cases that involve the coadministration of dexmedetomidine can be more precise through the use of an EEG DSA than the use of BIS value. In accordant to this context, investigators have changed our institutional anesthetic propofol from BIS guidance to the DSA guidance and based on the retrospective analysis, investigators further observed the profound anesthetic-sparing effects and potential postoperative benefits of EEG DSA-guided anesthesia comparing to the BIS-guided anesthesia (doi: 10.4097/kja.23118). Therefore, further prospective randomized controlled is warranted to shape the real clinical benefits of DSA-guided multimodal general anesthesia.
- Conditions
- Craniotomy
- Being tested
- EEG spectrogram, Bispectral index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG spectrogramDevice
In the experimental group, the general anesthesia is guided by using the EEG spectrogram.
Bispectral indexDevice
In the control group, the general anesthesia is guided by using the bispectral index
| Study group | Role | What they receive |
|---|---|---|
| EEG Spectrogram-guided | Experimental | The general anesthesia administration is guided by using the EEG spectrogram in this group. Other perioperative care protocols are the same between the two study group. Receives: Device: EEG spectrogram |
| Bispectral index-guided | Active comparator | The general anesthesia administration is guided by using the processed EEG index, namely the bispectral index (BIS) in this group. Other perioperative care protocols are the same between the two study group. Receives: Device: Bispectral index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative anesthetic dose
We aim to compare the intraoperative propofol consumptions between the two study groups
Measured: 4-6 hours
Secondary outcomes (1)
Postoperative neurological complication incidence
We aim to compare the postoperative neurological complication incidence between the two study groups
Measured: During the hospital stays; approximately 7-10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study startFeb 2024 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CraniotomyStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chun-Yu Wu, Principal investigator, National Taiwan University Hospital Hsinchu Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06244017
- Sponsor's protocol ID
- 202312067DINA
- Status last verified
- Jan 2024
- First submitted
- 29 Jan 2024
- Last updated
- 7 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparisons Between Electroencephalographic Spectrogram-guided and Bispectral Index-guided Multimodal General Anesthesia During Craniotomy- a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06244017
- Acronym / sponsor ID
- 202312067DINA
- Conditions
- Craniotomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Feb 2024 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 6 Feb 2024 (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.
In this trial, investigators aimed to compared the clinical effects between the electroencephalographic (EEG) spetrogram-guided and processed EEG index-guided multimodal general anesthesia using the combination of propofol, dexmedetomidine, remifentnil and the scalp block in patients undergoing elective craniotomy.
Detailed description
The multimodal general anesthesia involved the administration of combinations of antinociceptive agents and hypnotics using electroencephalographic (EEG) based monitors to achieve a balanced state of anesthesia. Traditionally, the adjustment of general anesthesia drugs has been done using instruments like the Bispectral Index (BIS), which converts frontal lobe EEG signals into a numerical range of 0-100. This allows anesthesiologists to assess drug dosage and depth of anesthesia. However, numerical conversion may not accurately reflect individual variations and cannot precisely calculate drug concentrations in the case of multiple drug combinations.
For instance, dexmedetomidine (DEX) is currently one of the most commonly used drugs in multimodal generagal anesthesia.Because each anesthetic produces distinct brain states that are readily visible in an EEG density spectral array (DSA) and can be easily interpreted by anesthesiologists, anesthetic titration based on an EEG DSA may provide additional information for anesthetic depth monitoring and may avoid the conventional 'one-index-fits-all' approach, which often ignores the influence of anesthetic drug combination. Theoretically, the anesthetic exposure in cases that involve the coadministration of dexmedetomidine can be more precise through the use of an EEG DSA than the use of BIS value. In accordant to this context, investigators have changed our institutional anesthetic propofol from BIS guidance to the DSA guidance and based on the retrospective analysis, investigators further observed the profound anesthetic-sparing effects and potential postoperative benefits of EEG DSA-guided anesthesia comparing to the BIS-guided anesthesia (doi: 10.4097/kja.23118). Therefore, further prospective randomized controlled is warranted to shape the real clinical benefits of DSA-guided multimodal general anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EEG Spectrogram-guided | Experimental | Device: EEG spectrogramThe general anesthesia administration is guided by using the EEG spectrogram in this group. Other perioperative care protocols are the same between the two study group. |
| Bispectral index-guided | Active comparator | Device: Bispectral indexThe general anesthesia administration is guided by using the processed EEG index, namely the bispectral index (BIS) in this group. Other perioperative care protocols are the same between the two study group. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing elective craniotomy
Key exclusion criteria (4 listed)
- revision surgery
- heart failure
- liver cirrhosis > Child B class
- chronic obstructive pulmonary disease
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 |
|---|---|---|
| EEG spectrogramIn the experimental group, the general anesthesia is guided by using the EEG spectrogram. | Device | EEG Spectrogram-guided |
| Bispectral indexIn the control group, the general anesthesia is guided by using the bispectral index | Device | Bispectral index-guided |
Primary outcome
Intraoperative anesthetic dose
Time frame: 4-6 hours
We aim to compare the intraoperative propofol consumptions between the two study groups
1 secondary outcome
Postoperative neurological complication incidence
Time frame: During the hospital stays; approximately 7-10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
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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.
Chun-Yu Wu principal investigator
National Taiwan University Hospital Hsinchu Branch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EEG spectrogram and Bispectral index in people with Craniotomy, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 inclusion and 4 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 7 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 Taiwan. 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 Chun-Yu Wu (886976653376, b001089018@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative anesthetic dose (time frame: 4-6 hours). 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 7 Feb 2024.