The Effects of Mild Sedation on Motor Function Networks in Patients With Brian Gliomas
- Registration Number
- NCT03984240
- Lead Sponsor
- Beijing Tiantan Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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;
- Education background is beyond high school;
- Right handedness
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Brain eloquent area glioma group Midazolam The brain eloquent area glioma will be diagnosed by MRI scan. Brain eloquent area glioma group Dexmedetomidine The brain eloquent area glioma will be diagnosed by MRI scan. control group Midazolam Healthy volunteers without intracranial diseases. control group Dexmedetomidine Healthy volunteers without intracranial diseases.
- Primary Outcome Measures
Name Time Method Brain network connectivity 2 hours following sedation will use fMRI and DTI
- Secondary Outcome Measures
Name Time Method pathological diagnose of glioma 2 weeks after surgery completion the detailed type of glioma and WHO glioma grade
upper limb's motor function 2 hours following sedation will use 9-hole peg test and motor/sensory function evaluation
Trial Locations
- Locations (1)
Beijing Tiantan Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China