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
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Dexmedetomidine
• Emergence Delirium
• Postoperative Delirium
• Propofol

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