A Phase II Clinical Two-Stage Study of Transcranial Magnetic Stimulation in Preventing Postoperative Delirium in Elderly Patients After Urological Surgery
1 other identifier
interventional
220
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 9, 2026
CompletedFirst Posted
Study publicly available on registry
March 18, 2026
CompletedStudy Start
First participant enrolled
March 20, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
March 18, 2026
March 1, 2026
2.7 years
March 9, 2026
March 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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
From the day of surgery to 7 days after surgery
Study Arms (1)
Perform transcranial magnetic stimulation on elderly patients undergoing urological surgery
EXPERIMENTALCases 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)
Interventions
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)
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chair of the Department of Anesthesiology
Study Record Dates
First Submitted
March 9, 2026
First Posted
March 18, 2026
Study Start
March 20, 2026
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
March 18, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share