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TerminatedNo phase

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

Key facts

Who runs it
RenJi Hospital
Where
China9 sites in 1 countryChoose a country to see its sites
Trial code
Status
Terminated
People taking part
797 people enrolled
Started
21 Nov 2022
Ended
30 Jul 2025
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Droperidol Injection
  • Saline
Record updated
12 August 2026
Why it 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.

Who can take part

Age
65 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 19 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • 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
  • Corrected QT (QTc) of electrocardiogram> 500ms
  • Morbid obesity with BMI >35 kg/m2
  • 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

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Experimental groupTreatment being tested

    Droperidol 1.25mg/0.5ml

    Treatment: Droperidol Injection

  • Placebo groupPlacebo, for comparison

    Normal saline 0.5ml

    Treatment: Saline

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Low-dose Droperidol for Prevention of Postoperative Delirium in Elderly Patients After Non-cardiac Surgery: A Randomized, Double-blind, Placebo-controlled Trial
Record updated
12 August 2026