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

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ClinicalTrials.gov Identifier: NCT03984240
Recruitment Status : Not yet recruiting
First Posted : June 12, 2019
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
Nan Lin, 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.

Condition or disease Intervention/treatment Phase
Brain Glioma Drug: Midazolam Drug: Dexmedetomidine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : December 31, 2021


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.




Primary Outcome Measures :
  1. Brain network connectivity [ Time Frame: 2 hours following sedation ]
    will use fMRI and DTI


Secondary Outcome Measures :
  1. upper limb's motor function [ Time Frame: 2 hours following sedation ]
    will use 9-hole peg test and motor/sensory function evaluation

  2. pathological diagnose of glioma [ Time Frame: 2 weeks after surgery completion ]
    the detailed type of glioma and WHO glioma grade



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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03984240


Contacts
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Contact: Nan LIN, MD, PhD 8610-13810108927 linnan127@gmail.com

Sponsors and Collaborators
Beijing Tiantan Hospital
Investigators
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Principal Investigator: Nan LIN Beijing Tiantan Hospital

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Responsible Party: Nan Lin, Principal Investigator, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier: NCT03984240     History of Changes
Other Study ID Numbers: 81701038
First Posted: June 12, 2019    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nan Lin, Beijing Tiantan Hospital:
midazolam, dexmedetomidine, motor function
Additional relevant MeSH terms:
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Tranquilizing Agents
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Midazolam
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Anti-Anxiety Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics