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

February 12, 2025 updated by: Yuming Peng, Beijing Tiantan Hospital

The Alterations of Brain Network Connectivity Under Sedation and Anesthesia 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100070
        • Recruiting
        • Beijing Tian Tan Hospital, Capital Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The population will be selected from patients who schedule to receive elective surgery in Beijing Tiantan Hospital.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Dex group
Participants will be sedated and maintained by dexmedetomidine.
Drug: Dexmedetomidine
Participants will be sedated and maintained by dexmedetomidine during the surgery.
Propofol group
Participants will be sedated and maintained by propofol.
Drug: Propofol
Participants will be sedated and maintained by propofol during the surgery.
Remimazolam group
Participants will be sedated and maintained by remimazolam.
Drug: Remimazolam Injection
Participants will be sedated and maintained by remimazolam during the surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Before sedation, 30 minutes after sedation，and 30 minutes after surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1-5 after surgery.
Electroencephalogram changes
Time Frame: From patients admission to operation room until 10 minutes after surgery
Electroencephalogram will be used to record the brain activity.
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
Regional cerebral oxygen saturation (rScO2) will be monitored with near-infrared spectroscopy (NIRS).
From patients admission to operation room until 10 minutes after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tiantan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2023

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

September 11, 2023

First Submitted That Met QC Criteria

November 16, 2023

First Posted (Actual)

November 18, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 12, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20230808

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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