Low-dose Neuroleptanalgesia for Postoperative Delirium in Elderly Patients (NCT05068180) | Clinical Trial Compass
UnknownPhase 4
Low-dose Neuroleptanalgesia for Postoperative Delirium in Elderly Patients
China200 participantsStarted 2021-10-05
Plain-language summary
Postoperative delirium（POD）is a common complication that can directly affect important clinical outcomes, and exert an enormous burden on patients, their families, hospitals, and public resources. In order to evaluate whether an intraoperative administration of low-dose neuroleptanalgesia reduces postoperative delirium, droperidol 1.25 mg and fentanyl 0.025 mg or normal saline is used by intravenous injection 30 minutes before the end of the operation, in elderly patients with non-cardiac major surgery under general anesthesia. The efficiency and safety of neuroleptanalgesia on the incidence of POD would be evaluated in elderly patients.
Who can participate
Age range
65 Years – 85 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
. Age ≥ 65 years old and ≤ 85 years old;
. Selective non-cardiac major surgery;
. Informed consent and voluntary participation in the trial;
. ASA class I-II;
. Anticipated operation duration ≥ 2 hours;
. No plan to ICU after operation.
Exclusion criteria
. Neurosurgery;
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
Incidences of POD after general anesthesia in elderly patients undergoing non-cardiac major surgery
Timeframe: Up to 7 days after surgery（or leaving hospital）
. Patients with neurological and mental diseases: such as basal ganglia disease, Parkinson's syndrome, severe central nervous depression, Alzheimer's disease , etc;
. Patients with prolonged Q-T interval, cardiac repolarization disorder and other severe arrhythmia;
. Patients with severe cardiopulmonary disease, liver and kidney dysfunction;
. Allergic or contraindications to droperidol or fentanyl citrate;