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

Sponsor
Beijing Tiantan Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06138340
Collaborator
(none)
120
1
28
4.3

Study Details

Study Description

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
120 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Alterations of Brain Network Connectivity Under Sedation and Anesthesia in Patients With Supratentorial Glioma
Actual Study Start Date :
Aug 31, 2023
Anticipated Primary Completion Date :
Nov 30, 2025
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. The alterations of brain network connectivity. [Before sedation, 30 minutes after sedation,and 30 minutes after surgery.]

    fMRI and DTI will be used to detect brain network connectivity.

Secondary Outcome Measures

  1. Postoperative delirium. [Day 1-5 after surgery.]

    The incidence and severity of postoperative delirium and its association with changes of brain network connectivity.

  2. Electroencephalogram changes [From patients admission to operation room until 10 minutes after surgery]

    Electroencephalogram will be used to record the brain activity.

  3. rScO2 changes. [From patients admission to operation room until 10 minutes after surgery]

    Regional cerebral oxygen saturation (rScO2) will be monitored with near-infrared spectroscopy (NIRS).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing Tian Tan Hospital, Capital Medical University Beijing Beijing China 100070

Sponsors and Collaborators

  • Beijing Tiantan Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yuming Peng, Deputy chief of Department of Anesthesiology, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier:
NCT06138340
Other Study ID Numbers:
  • 20230808
First Posted:
Nov 18, 2023
Last Update Posted:
Nov 18, 2023
Last Verified:
Nov 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 18, 2023