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NCT06138340 Clinical Trial

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

Postoperative Delirium Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06138340
Other study ID # 20230808
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 31, 2023
Est. completion date December 31, 2025

Study information
Verified date November 2023
Source Beijing Tiantan Hospital
Contact Yuming Peng, MD,Ph.D
Phone 8610-59976658
Email florapym766@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 120
Est. completion date December 31, 2025
Est. primary completion date November 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
China Beijing Tian Tan Hospital, Capital Medical University Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary The alterations of brain network connectivity. fMRI and DTI will be used to detect brain network connectivity. Before sedation, 30 minutes after sedation,and 30 minutes after surgery.
Secondary Postoperative delirium. The incidence and severity of postoperative delirium and its association with changes of brain network connectivity. Day 1-5 after surgery.
Secondary Electroencephalogram changes Electroencephalogram will be used to record the brain activity. From patients admission to operation room until 10 minutes after surgery
Secondary rScO2 changes. Regional cerebral oxygen saturation (rScO2) will be monitored with near-infrared spectroscopy (NIRS). From patients admission to operation room until 10 minutes after surgery
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