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

Capital Medical University

Status: Completed

Conditions: Dexmedetomidine; Brain Glioma; Midazolam

Treatments: Drug: Dexmedetomidine; Drug: Midazolam

Study type: Interventional

Funder types: Other

Identifiers

NCT03984240

81701038

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: All

Ages: 25 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

38 participants in 2 patient groups

Frontal-Parietal Supratentorial Brain Glioma Group

Experimental group

Description:

The frontal-parietal brain area glioma being diagnosed by MRI scan.

Treatment:

Drug: Midazolam

Drug: Dexmedetomidine

control group

Active Comparator group

Description:

Healthy volunteers without intracranial diseases.

Treatment:

Drug: Midazolam

Drug: Dexmedetomidine