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NCT Number: NCT07480044

A Phase II Clinical Two-Stage Study of Transcranial Magnetic Stimulation in Preventing Postoperative Delirium in Elderly Patients After Urological Surgery

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.

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Key information

Conditions

Postoperative Delirium (POD) Adenocarcinoma Carcinoma Carcinoma, Renal Cell Confusion Delirium Emergence Delirium Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Kidney Diseases Kidney Neoplasms Kidney Tumor Male Urogenital Diseases Mental Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Prostate Cancer Prostatic Diseases Prostatic Neoplasms Signs and Symptoms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

Location contact

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

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

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;

Treatment and study plan

Transcranial Magnetic Stimulation Device

Device

Primary outcomes

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.

Secondary outcomes

The severity of postoperative delirium

Time frame: From the day of surgery to 7 days after surgery

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

Study contacts

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

Diansan Su, Phd

CONTACT

[email protected]

86+18616514088 ext. 86+18758189796

Weiliu Zhu, Master

CONTACT

[email protected]

86+057187236169 ext. 86+15858287662

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Registry information

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2028
First posted: Mar 18, 2026
Registry last updated: Mar 18, 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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