Clinical trial NCT03984240: The Effects of Mild Sedation on Motor Function Networks in Patients With Brian Gliomas
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Glioma
Midazolam
Dexmedetomidine
Keywords: functional MRI
Sensory Motor Function
Midazolam
Mild sedation
Dexmedetomidine
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2019-06-12
Enrollment: 38
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Brain network connectivity
timeFrame: 2 hours following sedation
Secondary outcomes:
measure: upper limb's motor function
timeFrame: 2 hours following sedation
measure: pathological diagnose of glioma
timeFrame: 2 weeks after surgery completion
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Nan LIN
role: PRINCIPAL_INVESTIGATOR
References: