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

NCT ID: NCT03984240

Last Updated: 2025-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-25
• Study Completion Date: 2024-01-31

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.

Conditions

Brain Glioma; Midazolam; Dexmedetomidine

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Frontal-Parietal Supratentorial Brain Glioma Group

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

Group Type: EXPERIMENTAL

Midazolam

Intervention Type: DRUG

Participant will be sedated by midazolam.

Dexmedetomidine

Intervention Type: DRUG

Participant will be sedated by dexmedetomidine.

control group

Healthy volunteers without intracranial diseases.

Group Type: ACTIVE_COMPARATOR

Midazolam

Intervention Type: DRUG

Participant will be sedated by midazolam.

Dexmedetomidine

Intervention Type: DRUG

Participant will be sedated by dexmedetomidine.

Interventions

Midazolam

Participant will be sedated by midazolam.

Intervention Type: DRUG

Dexmedetomidine

Participant will be sedated by dexmedetomidine.

Intervention Type: DRUG

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Nan Lin

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nan LIN

Role: PRINCIPAL_INVESTIGATOR

Beijing Tiantan Hospital

Locations

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

81701038

Identifier Type: -

Identifier Source: org_study_id