Actively Recruiting
Effect of Prophylactic Application of 40Hz Transcranial Stimulation in AICU on Incidence of Postoperative Delirium in Elderly Patients Undergoing Elective Gastrointestinal Surgery
Led by Henan Provincial People's Hospital · Updated on 2024-10-28
98
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Postoperative delirium is a sudden brain dysfunction that affects elderly patients after surgery, marked by changes in consciousness, attention, thinking, and sleep cycles. It is a common complication among older adults, especially those receiving mechanical ventilation in intensive care. Researchers are studying the effect of exogenous 40Hz stimulation on the occurrence of postoperative delirium in elderly patients having planned gastrointestinal surgery in the acute intensive care unit (AICU). Participants are randomly assigned to one of two groups after admission to AICU: the experimental group receives 40Hz transcranial stimulation for 6 hours, while the control group does not receive this stimulation. This 40Hz stimulation is a physical device intervention that can influence brain activity and is thought to reduce markers linked to cognitive decline. The study is designed with quadruple masking to compare these groups effectively. During the study, researchers monitor participants for postoperative delirium daily from the first to the seventh day after surgery. They also assess blood markers at several time points after transfer to AICU, evaluate sleep quality each morning for the first three days, and track pain occurrence at 6, 24, and 48 hours post-surgery. This comprehensive monitoring aims to understand the impact of 40Hz stimulation on cognitive function and recovery in elderly surgical patients.
CONDITIONS
Brief Title
Effect of Prophylactic Application of 40Hz Transcranial Stimulation in AICU on Incidence of Postoperative Delirium in Elderly Patients Undergoing Elective Gastrointestinal Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 65 years or older, any gender
- ASA classification I to III
- Scheduled for elective gastrointestinal surgery with general anesthesia
You will not qualify if you...
- History of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis
- Preoperative coma, severe dementia, speech impairment, or severe illness limiting communication
- Delirium on admission or preoperative delirium, brain injury
- Severe infection
- Severe liver dysfunction (Child-Pugh C) or severe renal insufficiency requiring preoperative dialysis
- Severe hearing or vision impairment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 hours
Participants admitted to the AICU receive the 40Hz transcranial stimulation for 6 hours or no stimulation depending on their group assignment.
1 visit (in-person) after surgery upon admission to AICU
Duration - 7 days
Participants are monitored for the incidence of postoperative delirium, blood markers, sleep quality, and pain during the first 7 days after surgery.
Daily assessments for 7 days after surgery with specific measurements at half hour, 6 hours, 24 hours, and 48 hours after transfer to AICU; sleep quality checked each morning for 3 days
Trial Site Locations
Total: 1 location
1
Henan People's Hospital
Zhengzhou, Henan, China
Actively Recruiting
Research Team
Z
Zhang jiaqiang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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