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Recruiting NCT06138340

The Effects of Anesthetics on Brain Network Connectivity in Patients With Supratentorial Glioma

Observational Brain Network Connectivity Postoperative Delirium Dexmedetomidine Propofol

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dexmedetomidine, Propofol, Remimazolam Injection.
Who it may be relevant to
Registry conditions: Brain Network Connectivity, Postoperative Delirium, Dexmedetomidine, Propofol. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Drug Dexmedetomidine
    Participants will be sedated and maintained by dexmedetomidine during the surgery.
  • Drug Propofol
    Participants will be sedated and maintained by propofol during the surgery.
  • Drug Remimazolam Injection
    Participants will be sedated and maintained by remimazolam during the surgery.

Primary outcome measures

  • The alterations of brain network connectivity. [Time frame: Before sedation, 30 minutes after sedation,and 30 minutes after surgery.]
Secondary outcome measures (3)
  • Postoperative delirium. [Time frame: Day 1-5 after surgery.]
  • Electroencephalogram changes [Time frame: From patients admission to operation room until 10 minutes after surgery]
  • rScO2 changes. [Time frame: From patients admission to operation room until 10 minutes after surgery]

Eligibility criteria

Inclusion criteria

  • Diagnosed as unilateral supratentorial glioma by MRI
  • Selective operation
  • Age over 18 years old
  • ASA I-II
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Beijing Tian Tan Hospital, Capital Medical University — Beijing

Identifiers

NCT: NCT06138340 · 20230808

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗