Postoperative Delirium (POD)NCT07480044
A Phase II Clinical Two-Stage Study of Transcranial Magnetic Stimulation in Preventing Postoperative Delirium in Elderly Patients After Urological Surgery
A study testing Transcranial Magnetic Stimulation Device in people with Postoperative Delirium (POD) and Prostate Cancer, run by Zhejiang University at 1 site in China.
Trial summary
Cases were included based on the inclusion and exclusion criteria, and induction, maintenance, and recovery were conducted in accordance with the standard protocol for general anesthesia. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Postoperative Delirium (POD), Prostate Cancer, Kidney Tumor
- What is being tested?
- Transcranial Magnetic Stimulation Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2026to 1 Dec 2028
- Phase
- Interventional
- 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
Inclusion Criteria:(1) Age ≥ 60 years old; (2) Patients scheduled for elective urological surgery under general anesthesia with tracheal intubation; (3) ASA classification I - III; (4) Estimated operation duration ≥ 2 hours; (5) Informed consent from the patient or their guardian; (6) Proficient in communicating in Chinese. -
Exclusion Criteria:(1) Patients with permanent lack of autonomy (2) Not applicable for delirium assessment: including language disorders, deafness, blindness or aphasia, coma (3) With treatment abandonment or brain death (4) Known pregnancy or lactation (5) Unable to obtain consent according to national regulations (6) Patients forcibly hospitalized by regulatory authorities (compulsory measures) (7) With cardiac pacemaker or stent implantation (8) Patients with delirium (9) Patients with known brain lesions (10) Patients with known epilepsy history, having taken drugs that can cause epileptic seizures, having metal implants in the neck or brain, or having cerebral hemorrhage ，Acute phase, acute infectious diseases (11) Habitual treatment with antipsychotic drugs (12) Received antipsychotic drug treatment in the ICU before enrollment (13) Patients with severe liver dysfunction (Child-Pugh C grade) (14) Patients with severe kidney dysfunction (requiring dialysis before surgery) (15) Severe heart failure (METS < 4) (16) Preoperative cognitive impairment as determined by a MoCA evaluation prior to surgery;
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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
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
zhuweiliu1988@163.com
About this study
Cases were included based on the inclusion and exclusion criteria, and induction, maintenance, and recovery were conducted in accordance with the standard protocol for general anesthesia. After tracheal intubation and before tracheal tube removal at the end of the surgery, the parameters for iTBS stimulation frequency and duration were as follows: intensity was 80% of the active movement threshold, with 3 pulses per cluster at 50Hz, a frequency of 5Hz, 30 clusters of 10 pulses each, an 8 - second interval, and a single 600 - pulse; the 8 - shaped coil was connected to the electrodes in the designated head area (left frontal lobe cortex).Observation contents: Whether there is postoperative delirium and its severity: 3D - CAM assessment scale, DMAS assessment scale; awakening time, extubation time, PACU stay time, hospital stay time; 1 - 7 days after surgery or before discharge, POD assessment and pain - sleep assessment, the first time getting out of bed; postoperative complications; adverse reactions; adverse events, and so on.
- Conditions
- Postoperative Delirium (POD), Prostate Cancer, Kidney Tumor
- Being tested
- Transcranial Magnetic Stimulation Device
- Keywords
- Transcranial Magnetic Stimulation Device, elderly patients, Postoperative Delirium
- Medical subject headings
- Emergence Delirium, Prostatic Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic Stimulation DeviceDevice
Cases were included based on the inclusion and exclusion criteria, and induction, maintenance, and recovery were conducted in accordance with the standard protocol for general anesthesia. After tracheal intubation and before tracheal tube removal at the end of the surgery, the parameters for iTBS stimulation frequency and duration were as follows: intensity was 80% of the active movement threshold, with 3 pulses per cluster at 50Hz, a frequency of 5Hz, 30 clusters of 10 pulses each, an 8 - second interval, and a single 600 - pulse; the 8 - shaped coil was connected to the electrodes in the designated head area (left frontal lobe cortex)
| Study group | Role | What they receive |
|---|---|---|
| Perform transcranial magnetic stimulation on elderly patients undergoing urological surgery | Experimental | Cases were included based on the inclusion and exclusion criteria, and induction, maintenance, and recovery were conducted in accordance with the standard protocol for general anesthesia. After tracheal intubation and before tracheal tube removal at the end of the surgery, the parameters for iTBS stimulation frequency and duration were as follows: intensity was 80% of the active movement threshold, with 3 pulses per cluster at 50Hz, a frequency of 5Hz, 30 clusters of 10 pulses each, an 8 - second interval, and a single 600 - pulse; the 8 - shaped coil was connected to the electrodes in the designated head area (left frontal lobe cortex) Receives: Device: Transcranial Magnetic Stimulation Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative delirium within 7 days after surgery.
In the anesthesia recovery room, the CAM-ICU(The Confusion Assessment method for the ICU ) scale was performed 30 min after extubation. Postoperative delirium was measured by the 3D-CAM (The 3-Minute Diagnostic Confusion Assessment Method)scale from postoperative day 1 until postoperative day 7 or before discharge from the hospital. The CAM scale includes four major features: 1. Acute onset or fluctuating changes in condition 2. Inattention 3. Confusion 4. Changes in level of consciousness. Delirium is diagnosed when features 1 and 2 are positive at the same time, and/or features 3 and 4 are positive.
Measured: From the day of surgery to 7 days after surgery.Twice a day after surgery, once in the morning and once in the afternoon
Secondary outcomes (1)
The severity of postoperative delirium
If the patient develops delirium, assess the severity with the MDAS( Memory Disorder Assessment Scale).The total score is 30 points, and the higher the score, the greater the degree of delirium
Measured: From the day of surgery to 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start20 Mar 2026 (estimated)
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Delirium (POD)Studies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Transcranial Magnetic Stimulation Device
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diansan Su, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07480044
- Sponsor's protocol ID
- ZJU2026B0294
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Two-Stage Study of Transcranial Magnetic Stimulation in Preventing Postoperative Delirium in Elderly Patients After Urological Surgery
- ClinicalTrials.gov ID
- NCT07480044
- Acronym / sponsor ID
- ZJU2026B0294
- Conditions
- Postoperative Delirium (POD), Prostate Cancer, Kidney Tumor
- Keywords
- Transcranial Magnetic Stimulation Device, elderly patients, Postoperative Delirium
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 20 Mar 2026 (estimated)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 18 Mar 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.
Cases were included based on the inclusion and exclusion criteria, and induction, maintenance, and recovery were conducted in accordance with the standard protocol for general anesthesia. After tracheal intubation and before tracheal tube removal at the end of the surgery, the parameters for iTBS stimulation frequency and duration were as follows: intensity was 80% of the active movement threshold, with 3 pulses per cluster at 50Hz, a frequency of 5Hz, 30 clusters of 10 pulses each, an 8 - second interval, and a single 600 - pulse; the 8 - shaped coil was connected to the electrodes in the designated head area (left frontal lobe cortex).Observation contents: Whether there is postoperative delirium and its severity: 3D - CAM assessment scale, DMAS assessment scale; awakening time, extubation time, PACU stay time, hospital stay time; 1 - 7 days after surgery or before discharge, POD assessment and pain - sleep assessment, the first time getting out of bed; postoperative complications; adverse reactions; adverse events, and so on.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Transcranial Magnetic Stimulation Device
| Arm | Type | Receives |
|---|---|---|
| Perform transcranial magnetic stimulation on elderly patients undergoing urological surgery | Experimental | Device: Transcranial Magnetic Stimulation DeviceCases were included based on the inclusion and exclusion criteria, and induction, maintenance, and recovery were conducted in accordance with the standard protocol for general anesthesia. After tracheal intubation and before tracheal tube removal at the end of the surgery, the parameters for iTBS stimulation frequency and duration were as follows: intensity was 80% of the active movement threshold, with 3 pulses per cluster at 50Hz, a frequency of 5Hz, 30 clusters of 10 pulses each, an 8 - second interval, and a single 600 - pulse; the 8 - shaped coil was connected to the electrodes in the designated head area (left frontal lobe cortex) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Magnetic Stimulation DeviceCases were included based on the inclusion and exclusion criteria, and induction, maintenance, and recovery were conducted in accordance with the standard protocol for general anesthesia. After tracheal intubation and before tracheal tube removal at the end of the surgery, the parameters for iTBS stimulation frequency and duration were as follows: intensity was 80% of the active movement threshold, with 3 pulses per cluster at 50Hz, a frequency of 5Hz, 30 clusters of 10 pulses each, an 8 - second interval, and a single 600 - pulse; the 8 - shaped coil was connected to the electrodes in the designated head area (left frontal lobe cortex) | Device | Perform transcranial magnetic stimulation on elderly patients undergoing urological surgery |
Primary outcome
Incidence of postoperative delirium within 7 days after surgery.
Time frame: From the day of surgery to 7 days after surgery.Twice a day after surgery, once in the morning and once in the afternoon
In the anesthesia recovery room, the CAM-ICU(The Confusion Assessment method for the ICU ) scale was performed 30 min after extubation. Postoperative delirium was measured by the 3D-CAM (The 3-Minute Diagnostic Confusion Assessment Method)scale from postoperative day 1 until postoperative day 7 or before discharge from the hospital. The CAM scale includes four major features: 1. Acute onset or fluctuating changes in condition 2. Inattention 3. Confusion 4. Changes in level of consciousness. Delirium is diagnosed when features 1 and 2 are positive at the same time, and/or features 3 and 4 are positive.
1 secondary outcome
The severity of postoperative delirium
Time frame: From the day of surgery to 7 days after surgery
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 18 Mar 2026.
- Individual participant dataSharing planned: No
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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?
A study testing Transcranial Magnetic Stimulation Device in people with Postoperative Delirium (POD) and Prostate Cancer, run by Zhejiang University 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?
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 18 Mar 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 Diansan Su, Phd (86+18616514088 ext. 86+18758189796, 184872238@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative delirium within 7 days after surgery. (time frame: From the day of surgery to 7 days after surgery.Twice a day after surgery, once in the morning and once in the afternoon). 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 18 Mar 2026.