- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05375409
Evidence for Cognitive Compensation Mechanism in the Postoperative Delirium: a Prospective Multi-modal Neuroimaging Cohort Study in Patients With Frontal Glioma
Cognitive Compensation Mechanism in the Postoperative Delirium
Study Overview
Status
Conditions
Detailed Description
Delirium is an acute, reversible, widespread alteration of cognitive function characterized by fluctuating cognitive dysfunction, decreased level of consciousness, inattention, disorganized thinking, or disturbed sleep-wake cycles. Postoperative delirium is a common postoperative complication in surgical patients, occurring 1-3 days after surgery and fluctuating between 11-51% depending on the patient's age, type of surgery, and preoperative underlying disease. Postoperative delirium significantly increases perioperative complications and mortality and may leave severe long-term cognitive impairment. However, there is a relative lack of studies addressing delirium after neurosurgical craniotomy. This population may be at high risk for postoperative delirium given the direct impact of intracranial primary lesions on brain structure and function. Our team has completed a prospective cohort study (registry number: NCT03087838) enrolling 800 post-neurosurgical craniotomy patients and found for the first time that patients with gliomas had the highest incidence of postoperative delirium relative to other intracranial occupying lesions at 37.7%, especially frontal gliomas at 53.3%, and that the incidence of delirium was much higher in patients with high-grade gliomas than in patients with low The incidence of delirium was much higher in patients with high-grade gliomas than in patients with low-grade gliomas (50% vs. 16.7%) (the results of the study have not yet been published). Why is the incidence of postoperative delirium higher in patients with gliomas, especially frontal gliomas, than in other lesions, given that they are intracranial occurrences? This question caused us to think about it.
Glioma is the most common intracranial malignancy, accounting for approximately 80% of malignant brain tumors. Recent studies have found that neurocognitive dysfunction is a more common phenomenon in glioma patients and is closely associated with a decrease in health-related quality of life (HRQOL) in patients. Therefore, as the level of glioma treatment improves, patient survival is prolonged, and quality of life is increasingly emphasized, neurocognitive dysfunction has become a hot issue in the field of glioma. Postoperative delirium, as a clear and important "catalyst" for postoperative cognitive dysfunction, deserves more attention.
Given that the treatment of delirium is uncertain and that 30-40% of postoperative delirium is preventable, it is important to screen for high-risk groups. This project will explore the neuroanatomical basis of postoperative delirium in frontal glioma patients using multimodal magnetic resonance technology preoperatively, and integrate neuroimaging features and cognitive events with multidimensional clinical neurocognitive assessment to construct and validate a risk assessment model to predict postoperative delirium in this population. The significance of this study is: (1) to investigate the pathogenesis of postoperative delirium in frontal glioma patients, to explore the objective neuroimaging features with high specificity and sensitivity in vivo, and to provide new ideas and methods for the pathophysiological mechanisms of postoperative delirium; (2) the construction of the prediction model may help to provide early warning of postoperative delirium in glioma patients, which is of great clinical significance for perioperative management.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Beijing
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Beijing, Beijing, China, 100070
- Recruiting
- Department of Neurosugery, Beijing Tiantan Hospital
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Contact:
- Guobin Zhang, MD
- Phone Number: +86 13705355517
- Email: guobin_0912@sina.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients with frontal glioma as revealed by head MRI, aged 18-60 years, with no history of serious disease, and who signed an informed consent form were included in the study. Controls were healthy volunteers of the same age group used for functional MRI resting state data control.
Exclusion Criteria:
- (1) patients who cannot cooperate with preoperative neurocognitive assessment and preoperative functional MRI; (2) patients with psychiatric disorders; (3) patients with a history of hydrocephalus, cerebral infarction, or cerebral hemorrhage; (4) patients with epilepsy and a history of antiepileptic drugs; (5) patients who have taken sedative or analgesic drugs within 24 hours of study entry; (6) patients with drug and alcohol abuse; (7) patients with perinatal and lactating conditions; (8) patients with recurrent intracranial tumors; (9) patients with multiple intracranial tumors; (10) patients who have undergone surgery for radiation or chemotherapy; (11) patients with multiple intracranial tumors. (6) patients with drug and alcohol abuse; (7) perinatal and lactating patients; (8) patients with recurrent intracranial tumors; (9) patients with multiple intracranial tumors; (10) patients who have undergone surgery with radiotherapy or chemotherapy; (10) patients with claustrophobia.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Postoperative Delirium (+)
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Postoperative Delirium (-)
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Healthy Control
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
occurrance of postoperative delirium
Time Frame: 1-3day after surgery
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POD(+) POD(-)
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1-3day after surgery
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preoperative cognitive examination
Time Frame: before sugery
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cognitive scores
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before sugery
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Guobin Zhang
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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