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Clinical Trials/NCT06138340
NCT06138340
Recruiting
Not Applicable

The Alterations of Brain Network Connectivity Under Sedation and Anesthesia in Patients With Supratentorial Glioma

Beijing Tiantan Hospital1 site in 1 country120 target enrollmentAugust 31, 2023

Overview

Phase
Not Applicable
Intervention
Dexmedetomidine
Conditions
Brain Network Connectivity
Sponsor
Beijing Tiantan Hospital
Enrollment
120
Locations
1
Primary Endpoint
The alterations of brain network connectivity.
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

Perioperative anesthesia can affect postoperative cognitive function. In our previous study, intraoperative dexmedetomidine (Dex) infusion reduced the incidence of delirium within the first 5 days after brain tumor. However, the mechanism is still unclear. With the development of neuroimaging, multimodal neuroimaging technology provide a new method to explore the underlying mechanism. Therefore, the purpose of this study is to analyze the alterations of brain network under sedation and anesthesia by different anesthetics in patients with supratentorial glioma and their association with cognition.

Registry
clinicaltrials.gov
Start Date
August 31, 2023
End Date
December 31, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Beijing Tiantan Hospital
Responsible Party
Principal Investigator
Principal Investigator

Yuming Peng

Deputy chief of Department of Anesthesiology

Beijing Tiantan Hospital

Eligibility Criteria

Inclusion Criteria

  • Diagnosed as unilateral supratentorial glioma by MRI
  • Selective operation
  • Age over 18 years old
  • Right handedness

Exclusion Criteria

  • History of cerebrovascular disease, brain trauma, chemotherapy and radiotherapy, or psychotropic drugs
  • History of intracranial surgery
  • Drug and/or alcohol abuse
  • History of dementia or mental illness
  • Pregnant or lactating women
  • Contraindications for MRI
  • Severe bradycardia (heart rate less than 40 beats per minute), sick sinus syndrome or second-to-third degree atrioventricular block
  • Severe hepatic or renal dysfunction

Arms & Interventions

Dex group

Participants will be sedated and maintained by dexmedetomidine.

Intervention: Dexmedetomidine

Propofol group

Participants will be sedated and maintained by propofol.

Intervention: Propofol

Remimazolam group

Participants will be sedated and maintained by remimazolam.

Intervention: Remimazolam Injection

Outcomes

Primary Outcomes

The alterations of brain network connectivity.

Time Frame: Before sedation, 30 minutes after sedation,and 30 minutes after surgery.

fMRI and DTI will be used to detect brain network connectivity.

Secondary Outcomes

  • Electroencephalogram changes(From patients admission to operation room until 10 minutes after surgery)
  • rScO2 changes.(From patients admission to operation room until 10 minutes after surgery)
  • Postoperative delirium.(Day 1-5 after surgery.)

Study Sites (1)

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