The Effects of rTMS on Postoperative Cognitive Function in Patients After Cardiac Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 280
- Primary Endpoint
- The incidence of PND on the postoperative day 30
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18 years or older.
- •ASA class I - III, patients undergoing elective cardiac surgery(coronary artery bypass grafting, aortic or mitral valve surgery).
- •Sign the informed consent.
- •Able to complete follow-up visits.
Exclusion Criteria
- •A history of psychopathology and/or taking medication.
- •Previous history of neurological disease.
- •Severe organic diseases.
- •RTMS contraindications (such as a history of epileptic seizures, metal implants near the head).
- •Having delirium, assessed by CAM, before surgery.
- •Participating in other clinical studies at the time of screening.
- •Having a cardiopulmonary arrest and cardiopulmonary resuscitation.
- •Having short-term second operation.
Arms & Interventions
Active rTMS Group
A stimulation set will be administered to each participant in the rTMS group with 15 sessions stimulation for total five days after surgery.
Intervention: repetitive transcranial magnetic stimulation (Procedure)
Sham Stimulation Group
Patients randomly assigned to sham group will receive 15 sessions sham stimulation for total five days after surgery.
Intervention: Sham Stimulation (Procedure)
Outcomes
Primary Outcomes
The incidence of PND on the postoperative day 30
Time Frame: Within 30 days after surgery
Incidence of PND on the postoperative day 7 and day 30 will be defined according to the MOCA and MMSE.
Secondary Outcomes
- Perioperative pain(Within 7 days after surgery)
- Postoperative delirium incidence(Within 7 days after surgery)
- Sleep quality(Within 30 days after surgery)
- Depressive symptom(Within 7 days after surgery)
- Length of hospital stay(From the date of admission until discharged from hospital, up to 30 days)
- Incidence of major adverse cardiac and cerebral events(Within 30 days after surgery)
- Activities of daily living（ADL）(Within 30 days after surgery)
- Length of ICU stay(From the date of admission until discharged from ICU, up to 30 days)
- EEG characteristics(Within 30 days after surgery)
Investigators
Anshi Wu
Director of department of anesthesiology, Chaoyang Hospital
Beijing Chao Yang Hospital