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

March 13, 2026 updated by: Diansan Su, Zhejiang University
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Diansan Su, Phd
  • Phone Number: 86+18758189796 86+18616514088
  • Email: 184872238@qq.com

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • The first Affiliated Hospital, Zhejiang University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Perform transcranial magnetic stimulation on elderly patients undergoing 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)
Device: Transcranial Magnetic Stimulation Device
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From the day of surgery to 7 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 20, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

March 9, 2026

First Submitted That Met QC Criteria

March 13, 2026

First Posted (Actual)

March 18, 2026

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 13, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZJU2026B0294

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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