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

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.

Study Overview

• Status: Completed
• Conditions: Dexmedetomidine; Brain Glioma; Midazolam
• Intervention / Treatment: Drug: Midazolam; Drug: Dexmedetomidine

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100055
      • Beijing Tiantan Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control group; Healthy volunteers without intracranial diseases.	Drug: Midazolam; Participant will be sedated by midazolam.; Drug: Dexmedetomidine; Participant will be sedated by dexmedetomidine.
Experimental: Frontal-Parietal Supratentorial Brain Glioma Group; The frontal-parietal brain area glioma being diagnosed by MRI scan.	Drug: Midazolam; Participant will be sedated by midazolam.; Drug: Dexmedetomidine; Participant will be sedated by dexmedetomidine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brain network connectivity	will use fMRI and DTI	2 hours following sedation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
upper limb's motor function	will use 9-hole peg test and motor/sensory function evaluation	2 hours following sedation
pathological diagnose of glioma	the detailed type of glioma and WHO glioma grade	2 weeks after surgery completion

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Investigators: Principal Investigator: Nan LIN, Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2020
• Primary Completion (Actual): July 31, 2023
• Study Completion (Actual): January 31, 2024

Study Registration Dates

• First Submitted: June 8, 2019
• First Submitted That Met QC Criteria: June 11, 2019
• First Posted (Actual): June 12, 2019

Study Record Updates

• Last Update Posted (Actual): June 3, 2025
• Last Update Submitted That Met QC Criteria: May 29, 2025
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: functional MRI; Dexmedetomidine; Midazolam; Sensory Motor Function; Mild sedation
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Neurotransmitter Agents; Adjuvants, Anesthesia; Hypnotics and Sedatives; Anti-Anxiety Agents; Tranquilizing Agents; Psychotropic Drugs; Anesthetics, Intravenous; Anesthetics, General; GABA Modulators; GABA Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Midazolam; Dexmedetomidine
• Other Study ID Numbers: 81701038

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No