Postoperative Delirium, Transcranial Magnetic Stimulation, Repetitive
Conditions
Keywords
postoperative delirium, continuous theta burst stimulation
Brief summary
To investigate the impact of cTBS on the incidence of postoperative delirium and changes of cognitive function in elderly patients after surgery. To explore whether short-term cTBS can reduce the risk of postoperative delirium as a preventive strategy.
Detailed description
Postoperative delirium is the most common postoperative complications among elderly. Nevertheless, there remains no effective medication or intervention been approved in postoperative delirium. Recent research suggests that continuous theta burst stimulation (cTBS) has shown positive effect on improving global cognitive function in multiple mental disorders. However, the effects on cognitive function in postoperative delirium remain uninvestigated.
Interventions
Our active treatment consisted of 600 pulses per session, delivered over the right dorsolateral prefrontal cortex at 80% of resting motor threshold (RMT). Every session cTBS consists of 50 Hz triplets of pulses delivered at 5 Hz for 40 seconds for a total of 600 pulses. Every set simulation includes 3 sessions. All enrolled patient in the cTBS group received 1 set simulation per day with an intersession interval (ISI) of over 30 minutes during the hospitalization after the surgery. The first set of stimulation was given at 4 hours after the end of surgery on the day of surgery. The other sets of stimulation were given at 8 am, 8:30 am and 9:00 am on postoperative day 1and 2, respectively.
DEVICESham stimulation
The sham stimulation group received a sham cTBS (600 pulses per session, 3 sessions per day, ISI ≥ 30mins, 3 days) with the coil set at 90 against the skull. The first set of stimulation was given at 4 hours after the end of surgery on the day of surgery. The other sets of stimulation were given at 8 am, 8:30 am and 9:00 am on postoperative day 1 and 2, respectively.
Sponsors
Massachusetts General Hospital
Shanghai 10th People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants were included if they: 1. were 65 years old or older; 2. had orthopedic surgery under general anesthesia; 3. had normal cognitive function at enrolment \[for illiterate, Mini-Mental State Examination (MMSE) ≥ 17; for individuals with 1-6 years of education, MMSE ≥ 20; for individuals with 7 or more years of education, MMSE ≥ 24\]; 4. were able to complete cognitive assessments and the Confusion Assessment Method (CAM); 5. Chinese Mandarin as their native language; 6. were willing to participate and being competent to provide informed consent. Patients were excluded if they: 1. had delirium assessed by CAM before surgery; 2. had neurological diseases (e.g., stroke, Parkinson's disease, etc.) according to International Statistical Classification of Diseases and Related Health Problems 11th Revision (ICD-11); 3. had mental disorders (e.g., major depressive disorder, dementia, etc.) according to Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) (DSM-5); 4. had contraindications of cTBS (e.g., head trauma, history of epilepsy or metal implants in the head); 5. participating in other clinical studies at the time of screening; 6. having postoperative complications such as pulmonary infection, pulmonary embolism and stroke.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postoperative delirium | 3 days after surgery | Incidence of postoperative delirium on postoperative day 1, 2 and 3 was defined according to the confusion assessment methods (CAM). |
| Cognitive function related to delirium | 3 days after surgery | The cognitive function related to delirium was assessed by using Delirium Symptom Interview Daily (DSI Daily). |
| Severity of postoperative delirium | 3 days after surgery | Severity of postoperative delirium on postoperative day 1, 2 and 3 was defined according to he Confusion Assessment Method based delirium severity evaluation tool (CAM-S).The sum score of CAM-S ranges from 0 (no) to 19 (most severe). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain level | 3 days after surgery | This was assessed by using Visual Analogue Scale (VAS). The patients scored according to the severity of their pain from no pain (0) to most painful (10). |
| Rate of complication and mortality | up to 7 days after anesthesia/surgery | Rate of complication and mortality during the stay in hospital or up to 7 days after anesthesia/surgery, depending which one is longer |
| Sleep quality | 3 days after surgery | leep Quality was assessed by the Pittsburgh Sleep Quality Index (PSQI) at baseline (T0), and DSI Daily after surgery.The global PSQI score ranges from 0 to 21, where lower scores denote a healthier sleep quality. |
| Ability of daily living | up to 7 days after anesthesia/surgery | This was assessed by using Chinese version of Activity of Daily Living (ADL) Scale.The total score of ADLs ranges from 14 to 56 points and higher ADLs scores indicate lower activities of daily living. |
Countries
China
Outcome results
None listed