Brain GliomaNCT03984240
The Effects of Mild Sedation on Motor Function Networks in Patients With Brian Gliomas
A study testing Midazolam and Dexmedetomidine in people with Brain Glioma and Midazolam, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
It has been shown through functional MRI (Magnetic Resonance Imaging) that patients with gliomas in eloquent areas have compensated neurological function by virtue of brain post-injury reorganization. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Glioma, Midazolam, Dexmedetomidine
- What is being tested?
- Midazolam and Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteChina
- Study dates
- 25 Nov 2020to 31 Jan 2024
- 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 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 25 to 60 years old;
- Diagnosed as intracranial eloquent glioma by MRI, or healthy volunteer without any intracranial disease;
- Without history of chronic diseases;
- Without internal and/external metal object;
- Right handedness
Who cannot join
- Unable to cooperate the neurologic function evaluation;
- Neuropsychiatric disorders and/or taking antipsychotic medications;
- Drug and/or alcohol abuse;
- Receiving longterm sedatives and/or analgesics;
- Pregnant and/or lactation period patients;
- Present severe cardiovascular diseases;
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- Having claustrophobia;
- Body mass index equal or more than 35 kg/m2;
- Anticipated difficult airway;
- History of severe obstructive sleep apnea;
- History of reflux
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100055
About this study
Official title: The Effects of Mild Sedation on Compensatory Upper Limb Motor Function Networks Based on Multimodal Magnetic Resonance Imaging in With Gliomas in Brain Eloquent Areas
It has been shown through functional MRI (Magnetic Resonance Imaging) that patients with gliomas in eloquent areas have compensated neurological function by virtue of brain post-injury reorganization. Our previous clinical research found that mild sedation could induce and/or exacerbate neurological deficits, especially in limb motor and ataxia function, in these patients presumably by impairing functional compensation,. Nevertheless it is still very unclear how mild sedation affects sensorimotor networks in brains where reorganization may be present. Since eloquent area glioma patients are frequently subjected to sedation, anesthetics, and neurological examinations perioperatively, it is important to investigate how mild sedation interacts with motor network reorganization and functional compensation. Our research in patients with eloquent area gliomas will utilize neurological evaluations and multimodal MRI to explore the changes in brain upper limb' motor network reorganization after mild sedation by different sedatives-anesthetics. The neurological evaluations include sensorimotor function scale and testing tool. Multimodal MRI consists of 3-dimentional structure, blood oxygen-level dependent for cortical activation and diffusion tensor imaging for subcortical conduction. The data from the clinical testing and functional MRI will be processed and analyzed along with other relevant clinical information. This research will answer the question of how mild sedation affects upper limb motor function networks in brains with eloquent area gliomas. This new information will help optimize perioperative anesthetic and sedative choice for patients with eloquent area gliomas.
- Conditions
- Brain Glioma, Midazolam, Dexmedetomidine
- Being tested
- Midazolam, Dexmedetomidine
- Keywords
- functional MRI, Sensory Motor Function, Midazolam, Mild sedation, Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
Participant will be sedated by midazolam.
DexmedetomidineDrug
Participant will be sedated by dexmedetomidine.
| Study group | Role | What they receive |
|---|---|---|
| Frontal-Parietal Supratentorial Brain Glioma Group | Experimental | The frontal-parietal brain area glioma being diagnosed by MRI scan. Receives: Drug: Midazolam; Drug: Dexmedetomidine |
| control group | Active comparator | Healthy volunteers without intracranial diseases. Receives: Drug: Midazolam; Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain network connectivity
will use fMRI and DTI
Measured: 2 hours following sedation
Secondary outcomes (2)
upper limb's motor function
will use 9-hole peg test and motor/sensory function evaluation
Measured: 2 hours following sedation
pathological diagnose of glioma
the detailed type of glioma and WHO glioma grade
Measured: 2 weeks after surgery completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2019
- Study start25 Nov 2020
- Primary completion31 Jul 2023
- Study completion31 Jan 2024
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 Brain GliomaStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nan Lin, Beijing Tiantan Hospital
- Investigators
- Nan LIN, Principal investigator, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03984240
- Sponsor's protocol ID
- 81701038
- Status last verified
- Jul 2023
- First submitted
- 8 Jun 2019
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yin X, Wang Q, Gelb AW, Peng Y, Han R, Ma D, Zeng M, Dong J, Zhang X, Ma T, Jia X, Lin N. Disruption of Sensorimotor Network Connectivity in Patients With Supratentorial Gliomas During Mild Sedation With Midazolam: An Exploratory Interventional Study. J Neurosurg Anesthesiol. 2026 Sep 2. doi: 10.1097/ANA.0000000000001157. Online ahead of print.
PubMed 42683653
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Mild Sedation on Compensatory Upper Limb Motor Function Networks Based on Multimodal Magnetic Resonance Imaging in With Gliomas in Brain Eloquent Areas
- ClinicalTrials.gov ID
- NCT03984240
- Acronym / sponsor ID
- 81701038
- Conditions
- Brain Glioma, Midazolam, Dexmedetomidine
- Keywords
- functional MRI, Sensory Motor Function, Midazolam, Mild sedation, Dexmedetomidine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 25 Nov 2020 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 12 Jun 2019 (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.
It has been shown through functional MRI (Magnetic Resonance Imaging) that patients with gliomas in eloquent areas have compensated neurological function by virtue of brain post-injury reorganization. Our previous clinical research found that mild sedation could induce and/or exacerbate neurological deficits, especially in limb motor and ataxia function, in these patients presumably by impairing functional compensation,. Nevertheless it is still very unclear how mild sedation affects sensorimotor networks in brains where reorganization may be present. Since eloquent area glioma patients are frequently subjected to sedation, anesthetics, and neurological examinations perioperatively, it is important to investigate how mild sedation interacts with motor network reorganization and functional compensation. Our research in patients with eloquent area gliomas will utilize neurological evaluations and multimodal MRI to explore the changes in brain upper limb' motor network reorganization after mild sedation by different sedatives-anesthetics. The neurological evaluations include sensorimotor function scale and testing tool. Multimodal MRI consists of 3-dimentional structure, blood oxygen-level dependent for cortical activation and diffusion tensor imaging for subcortical conduction. The data from the clinical testing and functional MRI will be processed and analyzed along with other relevant clinical information. This research will answer the question of how mild sedation affects upper limb motor function networks in brains with eloquent area gliomas. This new information will help optimize perioperative anesthetic and sedative choice for patients with eloquent area gliomas.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Frontal-Parietal Supratentorial Brain Glioma Group | Experimental | Drug: Midazolam, Drug: DexmedetomidineThe frontal-parietal brain area glioma being diagnosed by MRI scan. |
| control group | Active comparator | Drug: Midazolam, Drug: DexmedetomidineHealthy volunteers without intracranial diseases. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age between 25 to 60 years old;
- Diagnosed as intracranial eloquent glioma by MRI, or healthy volunteer without any intracranial disease;
- Without history of chronic diseases;
- Without internal and/external metal object;
- Right handedness
Key exclusion criteria (11 listed)
- Unable to cooperate the neurologic function evaluation;
- Neuropsychiatric disorders and/or taking antipsychotic medications;
- Drug and/or alcohol abuse;
- Receiving longterm sedatives and/or analgesics;
- Pregnant and/or lactation period patients;
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 |
|---|---|---|
| MidazolamParticipant will be sedated by midazolam. | Drug | Frontal-Parietal Supratentorial Brain Glioma Group, control group |
| DexmedetomidineParticipant will be sedated by dexmedetomidine. | Drug | Frontal-Parietal Supratentorial Brain Glioma Group, control group |
Primary outcome
Brain network connectivity
Time frame: 2 hours following sedation
will use fMRI and DTI
2 secondary outcomes
upper limb's motor function
Time frame: 2 hours following sedation
pathological diagnose of glioma
Time frame: 2 weeks after surgery completion
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 3 Jun 2025.
- Derived from this study: PubMed 42683653Yin X, Wang Q, Gelb AW, Peng Y, Han R, Ma D, Zeng M, Dong J, Zhang X, Ma T, Jia X, Lin N. Disruption of Sensorimotor Network Connectivity in Patients With Supratentorial Gliomas During Mild Sedation With Midazolam: An Exploratory Interventional Study. J Neurosurg Anesthesiol. 2026 Sep 2. doi: 10.1097/ANA.0000000000001157. Online ahead of print.
- 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.
Nan LIN 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 Midazolam and Dexmedetomidine in people with Brain Glioma and Midazolam, 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 11 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 3 Jun 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?
Brain network connectivity (time frame: 2 hours following sedation). 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 NCT03984240, 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 3 Jun 2025; AzTrials last refreshed its copy on 6 Nov 2026.