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Completed

NCT Number: NCT03984240

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

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.

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Key information

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100055, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

midazolam

Drug

Participant will be sedated by midazolam.

Dexmedetomidine

Drug

Participant will be sedated by dexmedetomidine.

Primary outcomes

  1. Brain network connectivity

    Time frame: 2 hours following sedation

    will use fMRI and DTI

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Jun 12, 2019
Registry last updated
Jun 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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