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A Study for Postoperative Delirium in Older Patients With Intracranial Tumors

A Study on Prevention and Treatment Mechanisms for Postoperative Delirium in Older Patients With Intracranial Tumors

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07797660
Enrollment
164
Registered
2026-09-01
Start date
2026-08-30
Completion date
2027-09-30
Last updated
2026-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Tumor, Delirium

Brief summary

Postoperative delirium is a common acute central nervous system syndrome, which often occurs 1-5 days after surgery. Postoperative delirium can prolong the length of hospital stay, increase the mortality rate, and is also associated with long-term postoperative cognitive dysfunction. However, the pathogenesis of postoperative delirium in elderly patients undergoing neurosurgical procedures, who are at high risk for ostoperative delirium, remains unclear. This study aims to elucidate the underlying mechanisms of postoperative delirium in this population and inform the development of effective prevention and treatment strategies.

Interventions

None listed

Sponsors

Beijing Tiantan Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients undergoing elective craniotomy for intracranial tumour resection * Patients who will provide written informed consent

Exclusion criteria

* Patients with severe preoperative cognitive impairment precluding subsequent assessments * History of psychotropic medication use * Previous history of neurosurgical operation * Severe bradycardia (heart rate \< 40 beats per minute) * Sick-sinus syndrome or atrioventricular block of grade Ⅱ or above * Severe hepatic insufficiency (Child-Pugh grade C) * Renal failure requiring renal replacement therapy

Design outcomes

Primary

MeasureTime frameDescription
The association between intraoperative hypotension and postoperative deliriumThe surgery day and twice a day (from 8:00 to 10:00 and from 18:00 to 20:00) during the first postoperative 5 days.Intraoperative hypotension was defined by absolute mean arterial pressure (MAP) thresholds (sustained MAP \< 75, 70, 65, or 60 mm Hg for \> 1 min) or relative MAP reductions (10%, 20%, 30%, or 40% below preoperative baseline). The Confusion Assessment Method for the Intensive Care Unit scale (CAM-ICU) or 3 min diagnostic interview for CAM (3D-CAM) will be applied to assess postoperative delirium.

Secondary

MeasureTime frameDescription
Characteristic of electroencephalogramThe surgery dayElectroencephalographic signals will be acquired with the Masimo SedLine® monitor, which will yield the Patient State Index (PSI), burst-suppression ratio, raw EEG traces, density spectral array, spectral edge frequency, and electromyographic data. Frequency bands will be predefined as delta (1-3 Hz), theta (4-7 Hz), alpha (8-12 Hz), and beta (13-40 Hz). Relative power for each band will be computed relative to total spectral power.
Regional cerebral oxygen saturation changesThe surgery dayRegional cerebral oxygen saturation will be monitored with near-infrared spectroscopy.
Blood inflammatory factorsThe surgery dayArterial blood (4 mL) will be collected from patients during surgery, and blood inflammatory factors will be measured.

Countries

China

Contacts

CONTACTYuming Peng, M.D., Ph.D
florapym766@163.com8610-59976658

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 2, 2026