A Study for Postoperative Delirium in Older Patients With Intracranial Tumors

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.

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Key information

Conditions

Delirium Brain Diseases Brain Neoplasms Brain Tumor Central Nervous System Diseases Central Nervous System Neoplasms Confusion Mental Disorders Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Tian Tan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

The association between intraoperative hypotension and postoperative delirium

Time frame: The 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 outcomes

Characteristic of electroencephalogram

Time frame: The surgery day

Electroencephalographic 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 changes

Time frame: The surgery day

Regional cerebral oxygen saturation will be monitored with near-infrared spectroscopy.
Blood inflammatory factors

Time frame: The surgery day

Arterial blood (4 mL) will be collected from patients during surgery, and blood inflammatory factors will be measured.

Study contacts

Contact information is provided by the study sponsor or research team.

Yuming Peng, M.D., Ph.D

CONTACT

[email protected]

8610-59976658

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Sep 1, 2026
Registry last updated: Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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