To investigate the impact of rTMS on the incidence of perioperative neurocognitive disorders in patients after after cardiac surgerysurgery. To explore the underlying mechanisms behind the efficacy.
There is a relatively high incidence of perioperative neurocognitive disorders（PND） after surgeries, and the incidence is even higher in the geriatric population undergoing cardiac surgery. Nevertheless, there remains no effective medication or intervention been approved in PND. It has been shown that brain stimulation can improve cognitive function in mild cognitively impaired patients. However, the effects on cognitive function in PND remain uninvestigated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
280
The rTMS mode consists of a cluster stimulus delivered every 0.2 seconds (5 Hz), with each cluster stimulus consisting of three burst stimuli with a 50 Hz body frequency. The duration of a single stimulus was approximately 40 seconds, for a total of 600 pulses. Stimulation takes place bilaterally in the dorsolateral prefrontal cortex (DLPFC). All enrolled patient in the rTMS group will receive 1 set simulation per day with an intersession interval (ISI) of over 30 minutes on postoperative day 1 to 5 after the surgery.
Shaman stimulation uses the same protocol (600 pulses per session, 3 sessions per set, ISI≥30 min, 3 sets) with the coil set at 90 against the skull on postoperative day 1 to 5 after the surgery.
The incidence of PND on the postoperative day 30
Incidence of PND on the postoperative day 7 and day 30 will be defined according to the MOCA and MMSE.
Time frame: Within 30 days after surgery
Postoperative delirium incidence
Incidence of postoperative delirium on postoperative day 1 to 7 will be defined by the Confusion Assessment Method for The Intensive Care Unit (CAM-ICU) or CAM
Time frame: Within 7 days after surgery
Perioperative pain
This will be 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).
Time frame: Within 7 days after surgery
Sleep quality
We will use the Pittsburgh Sleep Quality Index (PSQI) to evaluate sleep quality. PSQI uses a 19-item questionnaire to assess sleep quality over one month30. An increased score indicates poor quality sleep. PSQI will be recorded at different points of time as follows： 1. 1 day before surgery 2. 7 days after surgery 3. 30 days after surgery
Time frame: Within 30 days after surgery
Depressive symptom
Depressive disorder and depression symptom severity will be measured using the 9-item patient health questionnaire (PHQ-9). It is self-administered and carries a score ranging from 0 to 27, with a score range of 0 to 3. Five, ten, fifteen, and twenty are the thresholds for mild, moderate, and moderately severe depression.
Time frame: Within 7 days after surgery
Activities of daily living（ADL）
As part of the pre-surgery and post-surgery evaluations, the Chinese version of the ADL scale will be used, including a Physical Self-Maintenance Scale and an Instrumental ADL scale. ADL consists of 14 items, and the total score ranges between 14 and 56 points, with higher scores indicating a lower level of functioning. ADL will be evaluated at different points of time as follows： 1. 1 day before surgery 2. 7 days after surgery 3. 30 days after surgery
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Time frame: Within 30 days after surgery
Length of hospital stay
A hospital length of stay is the number of days the patient spends in the hospital following surgery.
Time frame: From the date of admission until discharged from hospital, up to 30 days
Length of ICU stay
Similarly, the ICU length of stay was defined as the number of days the patient spent in the ICU before transferring to a general inpatient cardiac surgery ward
Time frame: From the date of admission until discharged from ICU, up to 30 days
EEG characteristics
Electroencephalography will be recorded at different points of time as follows and EEG characteristics including power in alpha, beta, theta, delta, gamma, spectrum will be extracted using MATLAB. In addition, functional brain connectivity and brain network will be assessed at different points of time as follows： 1. before anesthesia introduction 2. during anesthesia 3. on the 1th dayday after surgery 4. on the 7th day after surgery 5. on the 30th day after surgery
Time frame: Within 30 days after surgery
Incidence of major adverse cardiac and cerebral events
MACCE comprises all-cause mortality, myocardial infarction, repeat unplanned revascularization (surgical revision or percutaneous transluminal coronary angioplasty), and stroke
Time frame: Within 30 days after surgery