TerminatedNot Applicable

Low-dose Droperidol for Prevention of Postoperative Delirium in Elderly Patients After Non-cardiac Surgery

Stopped: The trial was terminated on the independent DSMB's recommendation after an interim analysis showed no evidence of benefit and a numerically higher incidence of postoperative delirium in the droperidol group, raising a potential safety concern.

China797 participantsStarted 2022-11-21

Plain-language summary

The aim of this multicenter, prospective, randomized, double-blind and large sample study is to explore the preventive effect of low-dose droperidol on POD in elderly patients after non-cardiac surgery, providing new approach for reducing the incidence of POD and improving the prognosis and quality of life.

Who can participate

Age range

65 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 * American Society of Anesthesiologists (ASA): I-III * Planning to undergo elective non-cardiac surgery under general anesthesia with endotracheal intubation, including digestive, orthopedic, urologic and gynecological surgery * Estimated operation time more than 2 hours * Not expected to be admitted to ICU postoperatively * Proficient in Chinese * Informed consent Exclusion Criteria: * Morbid obesity with BMI \>35 kg/m2; * History of psychological and neurological diseases, such as depression, schizophrenia, epilepsy, severe central nervous system depression, Parkinson's disease, Alzheimer's disease, myasthenia gravis, basal ganglia disease, etc; * Corrected QT (QTc) of electrocardiogram\> 500ms; * Preoperative liver insufficiency (Child Pugh grade C); * End-stage renal disease requiring dialysis; * Severe heart failure \[Metablic equivalent (METs)\<4\]; * Allergic to droperidol; * Inability to communicate due to coma or dementia in preoperative period; * Preoperative delirium, assessed by 3D-CAM; * More than three standard alcoholic drinks per day (≈10 g alcohol , equivalent to 50 g of strong Chinese spirits); * Participating in conflicting clinical trials; * Expected to have an additional operation within 7 days after the index operation.

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

Incidence of delirium within 7 days after operation

Timeframe: 7 days after operation

Trial details

NCT IDNCT05401058

SponsorRenJi Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-20

View on ClinicalTrials.gov More Digestive System Disease trials