NCT07480044

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Zhejiang University · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Postoperative Delirium (POD)
• Prostate Cancer
• Kidney Tumor

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2026-03-20
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2026-03-18
• Last updated: 2026-03-18

Locations

1 site across 1 country: China