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The Effects of Mild Sedation on Motor Function Networks in Patients With Brian Gliomas

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03984240
Enrollment
38
Registered
2019-06-12
Start date
2020-11-25
Completion date
2024-01-31
Last updated
2025-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Glioma, Dexmedetomidine, Midazolam

Keywords

functional MRI, Sensory Motor Function, Midazolam, Mild sedation, Dexmedetomidine

Brief 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. 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.

Interventions

DRUGMidazolam

Participant will be sedated by midazolam.

DRUGDexmedetomidine

Participant will be sedated by dexmedetomidine.

Sponsors

Beijing Tiantan Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
25 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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; * Having claustrophobia; * Body mass index equal or more than 35 kg/m2; * Anticipated difficult airway; * History of severe obstructive sleep apnea; * History of reflux

Design outcomes

Primary

MeasureTime frameDescription
Brain network connectivity2 hours following sedationwill use fMRI and DTI

Secondary

MeasureTime frameDescription
upper limb's motor function2 hours following sedationwill use 9-hole peg test and motor/sensory function evaluation
pathological diagnose of glioma2 weeks after surgery completionthe detailed type of glioma and WHO glioma grade

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 3, 2026