Brain Network ConnectivityNCT06138340
The Effects of Anesthetics on Brain Network Connectivity in Patients With Supratentorial Glioma
An observational study of Brain Network Connectivity and Postoperative Delirium, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
Perioperative anesthesia can affect postoperative cognitive function. In our previous study, intraoperative dexmedetomidine (Dex) infusion reduced the incidence of delirium within the first 5 days after brain tumor. However, the mechanism is still unclear. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Network Connectivity, Postoperative Delirium, Dexmedetomidine
- What is being tested?
- Dexmedetomidine, Propofol and Remimazolam Injection
- Type of treatment
- Injection or infusion
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population will be selected from patients who schedule to receive elective surgery in Beijing Tiantan Hospital.
Who may be able to join
- Diagnosed as unilateral supratentorial glioma by MRI
- Selective operation
- Age over 18 years old
- ASA I-II
- Right handedness
Who cannot join
- History of cerebrovascular disease, brain trauma, chemotherapy and radiotherapy, or psychotropic drugs
- History of intracranial surgery
- Drug and/or alcohol abuse
- History of dementia or mental illness
- Pregnant or lactating women
- Contraindications for MRI
- Severe bradycardia (heart rate less than 40 beats per minute), sick sinus syndrome or second-to-third degree atrioventricular block
- Severe hepatic or renal dysfunction
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tian Tan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
Yuming Peng, 8610-59976658, florapym766@163.com
About this study
Official title: The Alterations of Brain Network Connectivity Under Sedation and Anesthesia in Patients With Supratentorial Glioma
Perioperative anesthesia can affect postoperative cognitive function. In our previous study, intraoperative dexmedetomidine (Dex) infusion reduced the incidence of delirium within the first 5 days after brain tumor. However, the mechanism is still unclear. With the development of neuroimaging, multimodal neuroimaging technology provide a new method to explore the underlying mechanism. Therefore, the purpose of this study is to analyze the alterations of brain network under sedation and anesthesia by different anesthetics in patients with supratentorial glioma and their association with cognition.
- Being tested
- Dexmedetomidine, Propofol, Remimazolam Injection
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Participants will be sedated and maintained by dexmedetomidine during the surgery.
PropofolDrug
Participants will be sedated and maintained by propofol during the surgery.
Remimazolam InjectionDrug
Participants will be sedated and maintained by remimazolam during the surgery.
| Study group | Role | What they receive |
|---|---|---|
| Dex group | Participants will be sedated and maintained by dexmedetomidine. Receives: Drug: Dexmedetomidine | |
| Propofol group | Participants will be sedated and maintained by propofol. Receives: Drug: Propofol | |
| Remimazolam group | Participants will be sedated and maintained by remimazolam. Receives: Drug: Remimazolam Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The alterations of brain network connectivity.
fMRI and DTI will be used to detect brain network connectivity.
Measured: Before sedation, 30 minutes after sedation，and 30 minutes after surgery.
Secondary outcomes (3)
Postoperative delirium.
The incidence and severity of postoperative delirium and its association with changes of brain network connectivity.
Measured: Day 1-5 after surgery.
Electroencephalogram changes
Electroencephalogram will be used to record the brain activity.
Measured: From patients admission to operation room until 10 minutes after surgery
rScO2 changes.
Regional cerebral oxygen saturation (rScO2) will be monitored with near-infrared spectroscopy (NIRS).
Measured: From patients admission to operation room until 10 minutes after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start31 Aug 2023
- Primary completion30 Nov 2025 (estimated)
- Study completion31 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 Network ConnectivityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuming Peng, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06138340
- Sponsor's protocol ID
- 20230808
- Status last verified
- Feb 2025
- First submitted
- 11 Sep 2023
- Last updated
- 14 Feb 2025
- 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 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Alterations of Brain Network Connectivity Under Sedation and Anesthesia in Patients With Supratentorial Glioma
- ClinicalTrials.gov ID
- NCT06138340
- Acronym / sponsor ID
- 20230808
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 31 Aug 2023 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 Nov 2023 (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.
Perioperative anesthesia can affect postoperative cognitive function. In our previous study, intraoperative dexmedetomidine (Dex) infusion reduced the incidence of delirium within the first 5 days after brain tumor. However, the mechanism is still unclear. With the development of neuroimaging, multimodal neuroimaging technology provide a new method to explore the underlying mechanism. Therefore, the purpose of this study is to analyze the alterations of brain network under sedation and anesthesia by different anesthetics in patients with supratentorial glioma and their association with cognition.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dex group | – | Drug: DexmedetomidineParticipants will be sedated and maintained by dexmedetomidine. |
| Propofol group | – | Drug: PropofolParticipants will be sedated and maintained by propofol. |
| Remimazolam group | – | Drug: Remimazolam InjectionParticipants will be sedated and maintained by remimazolam. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population will be selected from patients who schedule to receive elective surgery in Beijing Tiantan Hospital.
Key inclusion criteria (5 listed)
- Diagnosed as unilateral supratentorial glioma by MRI
- Selective operation
- Age over 18 years old
- ASA I-II
- Right handedness
Key exclusion criteria (8 listed)
- History of cerebrovascular disease, brain trauma, chemotherapy and radiotherapy, or psychotropic drugs
- History of intracranial surgery
- Drug and/or alcohol abuse
- History of dementia or mental illness
- Pregnant or lactating women
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 |
|---|---|---|
| DexmedetomidineParticipants will be sedated and maintained by dexmedetomidine during the surgery. | Drug | Dex group |
| PropofolParticipants will be sedated and maintained by propofol during the surgery. | Drug | Propofol group |
| Remimazolam InjectionParticipants will be sedated and maintained by remimazolam during the surgery. | Drug | Remimazolam group |
Primary outcome
The alterations of brain network connectivity.
Time frame: Before sedation, 30 minutes after sedation，and 30 minutes after surgery.
fMRI and DTI will be used to detect brain network connectivity.
3 secondary outcomes
Postoperative delirium.
Time frame: Day 1-5 after surgery.
Electroencephalogram changes
Time frame: From patients admission to operation room until 10 minutes after surgery
rScO2 changes.
Time frame: From patients admission to operation room until 10 minutes after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
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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.
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 Network Connectivity and Postoperative Delirium, 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: looking for participants now, as of the sponsor's last update on 14 Feb 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuming Peng, MD,Ph.D (8610-59976658, florapym766@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The alterations of brain network connectivity. (time frame: Before sedation, 30 minutes after sedation，and 30 minutes after surgery.). 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 14 Feb 2025.