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

Sponsor
Beijing Tiantan Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03984240
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
35.9
Anticipated Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Sep 1, 2020
Anticipated Primary Completion Date :
Aug 31, 2023
Anticipated Study Completion Date :
Aug 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Brain eloquent area glioma group

The brain eloquent area glioma will be diagnosed by MRI scan.

Drug: Midazolam
Participant will be sedated by midazolam.

Drug: Dexmedetomidine
Participant will be sedated by dexmedetomidine.
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.

Outcome Measures

Primary Outcome Measures

  1. Brain network connectivity [2 hours following sedation]

    will use fMRI and DTI

Secondary Outcome Measures

  1. upper limb's motor function [2 hours following sedation]

    will use 9-hole peg test and motor/sensory function evaluation

  2. pathological diagnose of glioma [2 weeks after surgery completion]

    the detailed type of glioma and WHO glioma grade

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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;

  • Education background is beyond high school;

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing Tiantan Hospital, Capital Medical University Beijing Beijing China 100055

Sponsors and Collaborators

  • Beijing Tiantan Hospital

Investigators

  • Principal Investigator: Nan LIN, Beijing Tiantan Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nan Lin, Principal Investigator, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier:
NCT03984240
Other Study ID Numbers:
  • 81701038
First Posted:
Jun 12, 2019
Last Update Posted:
Mar 18, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nan Lin, Principal Investigator, Beijing Tiantan Hospital
midazolam, dexmedetomidine, motor function
Additional relevant MeSH terms:
Glioma
Midazolam
Dexmedetomidine

Study Results

No Results Posted as of Mar 18, 2022