Clinical trial

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

Name
20230808
Description
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.
Trial arms
Trial start
2023-08-31
Estimated PCD
2025-11-30
Trial end
2025-12-31
Status
Recruiting
Treatment
Dexmedetomidine
Participants will be sedated and maintained by dexmedetomidine during the surgery.
Arms:
Dex group
Propofol
Participants will be sedated and maintained by propofol during the surgery.
Arms:
Propofol group
Size
120
Primary endpoint
The alterations of brain network connectivity.
Before sedation, 30 minutes after sedation,and 30 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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}
Updated at
2023-11-18

1 organization

2 products

4 indications

Indication
Dexmedetomidine
Indication
Propofol
Product
Propofol