Patients with preoperative cognitive impairment are at increased risks of delayed neurocognitive recovery (DNR) and postoperative neurocognitive disorder (POCD). Repetitive transcranial magnetic stimulation (rTMS) has been used to improve cognitive function in patients with cognitive impairement. This trial is designed to compare the effects of rTMS versus sham intervention on postoperative neurocognitive function in patients with preoperative cognitive impairment.
Aged ≥65 years;
Patients with preoperative mild to moderate cognitive impairment, defined as 9<Montreal Cognitive Assessment (MoCA)<26;
Scheduled for elective non-cardiac surgery under general anesthesia, with an expected surgical duration of >2 hours;
Expected to stay in hospital for at least 5 days after surgery.
Left-handed;
Primary school education level or below;
Comorbid diseases including mental illness, intellectual disability, auditory and visual dysfunction, language impairment, severe neurological disorders, or other diseases that impede the completion of evaluation;
Neurosurgery;
Parallel
Repetitive transcranial magnetic stimulation
DeviceRepeated transcranial magnetic stimulation (rTMS) over left dorsolateral prefrontal cortex (DLPFC) for a 5-day period (1 day before surgery and 4 consecutive days after surgery, twice daily \[10-12 am and 6-8 pm\], no intervention on the day of the surgery). Parameters of rTMS: "8" shaped coil, 10 Hz, 80% resting motor threshold (RMT), 2000 pulses (5s × 40 trains, 25 s interval), 20 minutes.
Sham stimulation
DeviceSham repeated transcranial magnetic stimulation (rTMS) over left dorsolateral prefrontal cortex (DLPFC) for a 5-day period (1 day before surgery and 4 consecutive days after surgery, twice daily \[10-12 am and 6-8 pm\], no intervention on the day of the surgery). Parameters of rTMS: "8" shaped sham coil, 10 Hz, 80% resting motor threshold (RMT), 2000 pulses (5s × 40 trains, 25 s interval), 20 minutes.
Incidence of delayed neurocognitive recovery
Cognitive function is assessed with the Montreal Cognitive Assessment (MoCA; scores range from 0 to 30, with higher score indicating better function) before surgery and at 5 days after surgery. A MoCA score reduction of 1 standard deviation (SD) or more from baseline is defined as occurrence of delayed neurocognitive recovery.
Incidence of delirium
Delirium is assessed with the 3D-Confusion Assessment Method (for non-intubated patients) or Confusion Assessment Method for the Intensive Care Unit (for intubated patients) twice daily (8-10 am and 4-6 pm).
Incidence of postoperative neurocognitive disorder at 30 days after surgery
Cognitive function is assessed with the Telephone Montreal Cognitive Assessment (T-MoCA; scores range from 0 to 22, with higher score indicating better function) at 30±3 days after surgery. A T-MoCA score reduction of 1 standard deviation (SD) or more from baseline is defined as occurrence of postoperative neurocognitive disorder.
Incidence of postoperative neurocognitive disorder at 180 days after surgery
Cognitive function is assessed with the Telephone Montreal Cognitive Assessment (T-MoCA; scores range from 0 to 22, with higher score indicating better function) at 180±15 days after surgery. A T-MoCA score reduction of 1 standard deviation (SD) or more from baseline is defined as occurrence of postoperative neurocognitive disorder.
Pain intensity within 5 days after surgery
Pain intnsity is assessed with the Numerical Rating Scale (NRS, an 11-point scale where 0 = no pain and 10 = the worst pain) twice daily (8-10 am and 4-6 pm) during the first 5 days after surgery.
Length hospital stay after surgery
Length hospital stay after surgery.
Incidences of complications within 30 days after surgery
Postoperative complications are defined as new-onset medical events other than delirium that are deemed harmful and require therapeutic intervention, that is grade II or higher on the Clavien-Dindo classification.
Quality of life at 30 days after surgery
Quality of life is assessed with the World Health Organization Quality of Life brief version (WHOQOL-BREF), a 24-item questionnaire that assesses the quality of life in physical, psychological, and social relationship, and environmental domains. The score ranges from 0 to 100 for each domain, with higher score indicating better function.
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Peking University First Hospital
Lead sponsor
The First Affiliated Hospital of Air Force Medicial University
Collaborator
Peking University Shenzhen Hospital
Collaborator
