NCT03984240

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 12, 2019

Completed
1.5 years until next milestone

Study Start

First participant enrolled

November 25, 2020

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

June 3, 2025

Status Verified

July 1, 2023

Enrollment Period

2.7 years

First QC Date

June 8, 2019

Last Update Submit

May 29, 2025

Conditions

Brain GliomaMidazolamDexmedetomidine

Keywords

functional MRISensory Motor FunctionMidazolamMild sedationDexmedetomidine

Outcome Measures

Primary Outcomes (1)

  • Brain network connectivity

    will use fMRI and DTI

    2 hours following sedation

Secondary Outcomes (2)

  • upper limb's motor function

    2 hours following sedation

  • pathological diagnose of glioma

    2 weeks after surgery completion

Study Arms (2)

Frontal-Parietal Supratentorial Brain Glioma Group

EXPERIMENTAL

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

Drug: MidazolamDrug: Dexmedetomidine

control group

ACTIVE COMPARATOR

Healthy volunteers without intracranial diseases.

Drug: MidazolamDrug: Dexmedetomidine

Interventions

MidazolamDRUG

Participant will be sedated by midazolam.

Frontal-Parietal Supratentorial Brain Glioma Groupcontrol group
DexmedetomidineDRUG

Participant will be sedated by dexmedetomidine.

Frontal-Parietal Supratentorial Brain Glioma Groupcontrol group

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100055, China

Location

MeSH Terms

Interventions

MidazolamDexmedetomidine

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsImidazolesAzolesHeterocyclic Compounds, 1-Ring

Study Officials

  • Nan LIN

    Beijing Tiantan Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 8, 2019

First Posted

June 12, 2019

Study Start

November 25, 2020

Primary Completion

July 31, 2023

Study Completion

January 31, 2024

Last Updated

June 3, 2025

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)