A Study for Postoperative Delirium in Older Patients With Intracranial Tumors
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60+
SponsorBeijing Tiantan Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients undergoing elective craniotomy for intracranial tumour resection
Patients who will provide written informed consent
Disqualifiers
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)
Trial population
The study population will be selected from elderly patients scheduled to undergo elective craniotomy for intracranial tumour resection at Beijing Tiantan Hospital.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
164 Participants
are grouped into 2 trial groupsGroup A: Intraoperative hypotension
Group B: Without intraoperative hypotension
Trial outcomes
Primary outcomes
1
The association between intraoperative hypotension and postoperative delirium
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.
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.Secondary outcomes
1
Characteristic of electroencephalogram
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.
Time frame
The surgery day2
Regional cerebral oxygen saturation changes
Regional cerebral oxygen saturation will be monitored with near-infrared spectroscopy.
Time frame
The surgery day3
Blood inflammatory factors
Arterial blood (4 mL) will be collected from patients during surgery, and blood inflammatory factors will be measured.
Time frame
The surgery daySponsors and contacts
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Source ClinicalTrials.gov
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