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Efficacy of intermittent theta burst stimulation (iTBS) on postoperative delirium in elderly patients undergoing non-cardiac major surgery: a prospective, double-blind, randomized controlled trial

Efficacy of intermittent theta burst stimulation (iTBS) on postoperative delirium in elderly patients undergoing non-cardiac major surgery: a prospective, double-blind, randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500103149
Enrollment
Unknown
Registered
2025-05-26
Start date
2025-06-10
Completion date
Unknown
Last updated
2025-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

postoperative delirium

Interventions

Active stimulation group:The stimulation site is the left dorsolateral prefrontal cortex (DLPFC), specifically the F3 region. One session of iTBS treatment includes three 50Hz pulses, repeated at 5Hz
Sham stimulation group:Sham stimulation (sham coil), the timing and location are the same as the intervention group, routine postoperative analgesia

Sponsors

the Second Affiliated Hospital of Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age>=60 years, < 90 years; 2. Undergo elective/limited non-cardiac major surgery (operation duration=2 hours, general anesthesia, and expected hospital stay of at least 3 days); 3.ASA I~III level; 4. Voluntarily participate and sign the informed consent form; 5. Complete clinical data, able to complete preoperative questionnaire survey and postoperative follow-up.

Exclusion criteria

Exclusion criteria: 1. Refusal to participate in this study; 2. Inability to communicate due to coma, severe dementia or language impairment before surgery; 3. Preoperative schizophrenia, previous seizures or risk of seizures, Parkinson's disease, myasthenia gravis; 4. Severe heart, brain, kidney, and liver function abnormalities; 5. The skull defect is not repaired; 6. Have a metal or pacemaker implant; 7. Accompanied by other diseases that may affect the indicators of inflammatory response (such as infection, autoimmune diseases, tumors, etc.); 8. Patients with ASA grade IV and/or expected survival <=24h.

Design outcomes

Primary

MeasureTime frame
Postoperative delirium(POD) incidence;

Secondary

MeasureTime frame
Severity of POD;Postoperative sleep quality; Pain;High-sensitivity C-reactive protein (hs-CRP);TNF-a level in peripheral blood; IL-6; IL-1ß;

Countries

China

Contacts

Public ContactWan Xing

The Second Affiliated Hospital of Nanjing Medical University

3278671@qq.com+86 153 0516 9660

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026