Brain SurgeryNCT05656547
EEG DSA-guided Intravenous Anesthesia Using Dexmedetomidine and Propofol
An observational study of Brain Surgery, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Investigators conduct this retrospective analysis to test this hypothesis that the EEG spectrogram guided general anesthesia with dexmedetomidine co-administration with propofol may significantly reduce the propofol consumption during craniotomy and to investigate potential benefits on postoperative outcomes. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Brain Surgery
- Type of treatment
- Injection or infusion
- How many people
- 140 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 Dec 2022to 25 Feb 2023
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing elective craniotomy for brain tumor resection, aneurysm clipping, an intracranial bypass procedure, or microvascular decompression.
Who may be able to join
- Patients undergoing elective craniotomy for brain tumor resection, aneurysm clipping, an intracranial bypass procedure, or microvascular decompression
- age between 20 to 80 yr
Who cannot join
- Fever, elevated white blood cell or C-reactive protein
- Impaired liver function, eg. AST or ALT >100; liver cirrhosis > Child B class
- Impaired renal function, cGFR< 60 ml/min/1.73 m2
- Cardiac dysfunction, such as heart failure > NYHA class II
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Chun-Yu Wu, 886-2-23562158, b001089018@tmu.edu.tw
About this study
Official title: Anesthetic Sparing Effects of Dexmedetomidine During Craniotomy: a Retrospective Propensity Score Matching Comparison Between Encephalographic Spectrogram-guided and Processes Encephalographic Index-guided Protocol
Investigators conduct this retrospective analysis to test this hypothesis that the EEG spectrogram guided general anesthesia with dexmedetomidine co-administration with propofol may significantly reduce the propofol consumption during craniotomy and to investigate potential benefits on postoperative outcomes.
Read the detailed description
The bispectral index (BIS), is widely applied to maintain anesthetic depth. However, this processed EEG index may be ambiguous when dexmedetomidine is administrated. Because each anesthetic produces distinct brain states that are readily visible in the EEG spectrogram which can be easily interpreted by anesthesiologists, the EEG spectrogram-guided anesthesia is theoretically beneficial to avoid unnecessary anesthetic exposure when dexmedetomidine is co-administrated but this remains not yet clarified. Recently, the investigators reported a randomized controlled trial which revealed that co-administration of dexmedetomidine with propofol by using the BIS score guidance, is associated with profound propofol sparing effects and more favorable postoperative neurological outcomes (Eur J Anaesthesiol . 2021 Dec 1;38(12):1262-1271.). Based on the advance of knowledge of EEG spectrogram, the investigators have transited our practice based on the EEG spectrogram guidance. In this study, the investigators analyze the influence of EEG spectrogram guidance on the propofol sparing effect and the postoperative profile in comparison to patients of our previous BIS-guided protocol.
- Conditions
- Brain Surgery
- Keywords
- electroencephalogram, dexmedetomidine, total intravenous anesthesia, craniotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Encephalographic spectrogram group | The dexmedetomidine and propofol infusions were titrated to maintain robust alpha power in the encephalographic spectrogram | |
| Encephalographic index group | The dexmedetomidine and propofol infusions were titrated to maintain the bispectral index score between 40 and 60. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Propofol dose requirement
Intraoperative propofol consumption
Measured: 4-6 hours
Secondary outcomes (2)
Postoperative delirium
Postoperative delirium diagnosed using the Intensive Care Delirium Screening Checklist (ICDSC) criteria
Measured: During hospital stay, estimated 7-10 days
Postoperative Barthel index change
Barthel index changes between the states of admission and discharge
Measured: During hospital stay, estimated 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 posted19 Dec 2022
- Study start12 Dec 2022
- Primary completion25 Jan 2023 (estimated)
- Study completion25 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain SurgeryStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 140 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05656547
- Sponsor's protocol ID
- 202211078RINC
- Status last verified
- Dec 2022
- First submitted
- 11 Dec 2022
- Last updated
- 21 Dec 2022
- 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 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthetic Sparing Effects of Dexmedetomidine During Craniotomy: a Retrospective Propensity Score Matching Comparison Between Encephalographic Spectrogram-guided and Processes Encephalographic Index-guided Protocol
- ClinicalTrials.gov ID
- NCT05656547
- Acronym / sponsor ID
- 202211078RINC
- Conditions
- Brain Surgery
- Keywords
- electroencephalogram, dexmedetomidine, total intravenous anesthesia, craniotomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- 25 Jan 2023 (estimated)
- Study completion
- 25 Feb 2023 (estimated)
- First posted
- 19 Dec 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.
Investigators conduct this retrospective analysis to test this hypothesis that the EEG spectrogram guided general anesthesia with dexmedetomidine co-administration with propofol may significantly reduce the propofol consumption during craniotomy and to investigate potential benefits on postoperative outcomes.
Detailed description
The bispectral index (BIS), is widely applied to maintain anesthetic depth. However, this processed EEG index may be ambiguous when dexmedetomidine is administrated. Because each anesthetic produces distinct brain states that are readily visible in the EEG spectrogram which can be easily interpreted by anesthesiologists, the EEG spectrogram-guided anesthesia is theoretically beneficial to avoid unnecessary anesthetic exposure when dexmedetomidine is co-administrated but this remains not yet clarified. Recently, the investigators reported a randomized controlled trial which revealed that co-administration of dexmedetomidine with propofol by using the BIS score guidance, is associated with profound propofol sparing effects and more favorable postoperative neurological outcomes (Eur J Anaesthesiol . 2021 Dec 1;38(12):1262-1271.). Based on the advance of knowledge of EEG spectrogram, the investigators have transited our practice based on the EEG spectrogram guidance. In this study, the investigators analyze the influence of EEG spectrogram guidance on the propofol sparing effect and the postoperative profile in comparison to patients of our previous BIS-guided protocol.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Encephalographic spectrogram group | – | –The dexmedetomidine and propofol infusions were titrated to maintain robust alpha power in the encephalographic spectrogram |
| Encephalographic index group | – | –The dexmedetomidine and propofol infusions were titrated to maintain the bispectral index score between 40 and 60. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective craniotomy for brain tumor resection, aneurysm clipping, an intracranial bypass procedure, or microvascular decompression.
Key inclusion criteria (2 listed)
- Patients undergoing elective craniotomy for brain tumor resection, aneurysm clipping, an intracranial bypass procedure, or microvascular decompression
- age between 20 to 80 yr
Key exclusion criteria (4 listed)
- Fever, elevated white blood cell or C-reactive protein
- Impaired liver function, eg. AST or ALT >100; liver cirrhosis > Child B class
- Impaired renal function, cGFR< 60 ml/min/1.73 m2
- Cardiac dysfunction, such as heart failure > NYHA class II
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Propofol dose requirement
Time frame: 4-6 hours
Intraoperative propofol consumption
2 secondary outcomes
Postoperative delirium
Time frame: During hospital stay, estimated 7-10 days
Postoperative Barthel index change
Time frame: During hospital stay, estimated 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 21 Dec 2022.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Surgery, 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 2 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 21 Dec 2022. 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 (886-2-23562158, b001089018@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Propofol dose requirement (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 21 Dec 2022.