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NCT Number: NCT06138340

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

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.

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Key information

Conditions

Brain Network Connectivity Confusion Delirium Dexmedetomidine Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Delirium Propofol Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Tian Tan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

Location status: Recruiting

Location contact

Yuming Peng

CONTACT

[email protected]

8610-59976658

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Dexmedetomidine

Drug

Participants will be sedated and maintained by dexmedetomidine during the surgery.

Propofol

Drug

Participants will be sedated and maintained by propofol during the surgery.

Remimazolam Injection

Drug

Participants will be sedated and maintained by remimazolam during the surgery.

Primary outcomes

  1. 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

  1. Postoperative delirium.

    Time frame: Day 1-5 after surgery.

    The incidence and severity of postoperative delirium and its association with changes of brain network connectivity.

  2. Electroencephalogram changes

    Time frame: From patients admission to operation room until 10 minutes after surgery

    Electroencephalogram will be used to record the brain activity.

  3. rScO2 changes.

    Time frame: From patients admission to operation room until 10 minutes after surgery

    Regional cerebral oxygen saturation (rScO2) will be monitored with near-infrared spectroscopy (NIRS).

Study contacts

Contact information is provided by the study sponsor or research team.

Yuming Peng, MD,Ph.D

CONTACT

[email protected]

8610-59976658

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 18, 2023
Registry last updated
Feb 14, 2025

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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