Study of Acupuncture on Postoperative Delirium in Patients With Diabetes Mellitus (NCT05535985) | Clinical Trial Compass
UnknownNot Applicable
Study of Acupuncture on Postoperative Delirium in Patients With Diabetes Mellitus
215 participantsStarted 2023-01-01
Plain-language summary
1. To evaluate the effectiveness and safety of acupuncture on POD in diabetic patients undergoing surgery, to provide effective prevention and treatment measures of integrated traditional Chinese and western medicine for reducing the incidence of postoperative delirium in high-risk groups, and to provide clinical basis for further promotion of integrated traditional Chinese and western medicine anesthesia in the future.
2. To investigate the relationship between POD and rSO2 in diabetic patients undergoing surgery. To clarify the predictive value of intraoperative rSO2 monitoring on postoperative cognitive function in patients with diabetes, and to explore the effect of acupuncture on cerebral blood flow perfusion in patients with diabetes.
Who can participate
Age range
30 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients undergoing general anesthesia in our hospital
* Expected duration of operation \>2h
* Ages 18-60
* With type 2 diabetes
* American Society of Anesthesiologists (ASA) grade 2-3 , no severe respiratory, circulation, liver, kidney, coagulation function abnormalities;
* Expected postoperative hospital stay \>3 days
* No history of cerebrovascular accident in the past six months
* The informed consent signed
Exclusion Criteria:
* Unable or unwilling to cooperate with cognitive function scale tests
* MMSE score \<24
* Refuse acupuncture treatment or have a history of needle sickness
* With skin damage at the acupuncture sites
* Coagulation dysfunction
* Participated in other clinical studies
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of postoperative delirium
Timeframe: at 8 a.m. the day after surgery
2
Incidence of postoperative delirium
Timeframe: at 16 p.m. the day after surgery
3
Incidence of postoperative delirium
Timeframe: at 8 a.m. the second day after surgery
4
Incidence of postoperative delirium
Timeframe: at 16 p.m. the second day after surgery