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

NCT06138340 | Recruiting

• 1 other identifier: 20230808
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Brain Network Connectivity; Postoperative Delirium; Dexmedetomidine; Propofol

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Postoperative delirium.

  Day 1-5 after surgery.

• Electroencephalogram changes

  From patients admission to operation room until 10 minutes after surgery

• rScO2 changes.

  From patients admission to operation room until 10 minutes after surgery

Study Arms (3)

Dex group

Participants will be sedated and maintained by dexmedetomidine.

Drug: Dexmedetomidine

Propofol group

Participants will be sedated and maintained by propofol.

Drug: Propofol

Remimazolam group

Participants will be sedated and maintained by remimazolam.

Drug: Remimazolam Injection

Interventions

Dexmedetomidine DRUG

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

Dex group

Propofol DRUG

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

Propofol group

Remimazolam Injection DRUG

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

Remimazolam group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Diagnosed as unilateral supratentorial glioma by MRI
• Selective operation
• Age over 18 years old
• ASA I-II
• Right handedness

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tian Tan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

RECRUITING

MeSH Terms

Conditions

Emergence Delirium

Interventions

Dexmedetomidine; Propofol; remimazolam

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Yuming Peng, MD,Ph.D

CONTACT

8610-59976658; florapym766@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy chief of Department of Anesthesiology

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: November 18, 2023
• Study Start: August 31, 2023
• Primary Completion: November 30, 2025
• Study Completion: December 31, 2025
• Last Updated: February 14, 2025

Record last verified: 2025-02

Locations

CN (1)