DeliriumNCT07797660
A Study for Postoperative Delirium in Older Patients With Intracranial Tumors
An observational study of Delirium and Brain Tumor, run by Beijing Tiantan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Delirium, Brain Tumor
- How many people
- 164 participants
- Where
- 1 siteChina
- Study dates
- 30 Aug 2026to 30 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be selected from elderly patients scheduled to undergo elective craniotomy for intracranial tumour resection at Beijing Tiantan Hospital.
Who may be able to join
- Patients undergoing elective craniotomy for intracranial tumour resection
- Patients who will provide written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Tian Tan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
About this study
Official title: A Study on Prevention and Treatment Mechanisms 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.
- Conditions
- Delirium, Brain Tumor
- Medical subject headings
- Delirium, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Intraoperative hypotension | Not described | |
| Without intraoperative hypotension | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (3)
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.
Measured: The surgery day
Regional cerebral oxygen saturation changes
Regional cerebral oxygen saturation will be monitored with near-infrared spectroscopy.
Measured: The surgery day
Blood inflammatory factors
Arterial blood (4 mL) will be collected from patients during surgery, and blood inflammatory factors will be measured.
Measured: The surgery day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start30 Aug 2026 (estimated)
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuming Peng, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07797660
- Sponsor's protocol ID
- 2026-8
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Prevention and Treatment Mechanisms for Postoperative Delirium in Older Patients With Intracranial Tumors
- ClinicalTrials.gov ID
- NCT07797660
- Acronym / sponsor ID
- 2026-8
- Conditions
- Delirium, Brain Tumor
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 30 Aug 2026 (estimated)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 1 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intraoperative hypotension | – | – |
| Without intraoperative hypotension | – | – |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be selected from elderly patients scheduled to undergo elective craniotomy for intracranial tumour resection at Beijing Tiantan Hospital.
Key inclusion criteria (2 listed)
- Patients undergoing elective craniotomy for intracranial tumour resection
- Patients who will provide written informed consent
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Characteristic of electroencephalogram
Time frame: The surgery day
Regional cerebral oxygen saturation changes
Time frame: The surgery day
Blood inflammatory factors
Time frame: The surgery day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium and Brain Tumor, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuming Peng, M.D., Ph.D (8610-59976658, florapym766@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.