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OpenTrials
Terminated

NCT Number: NCT05401058

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

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.

Why the study 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.
Terminated

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Droperidol injection

Drug

About 30min before the end of operation, Droperidol 1.25mg/0.5ml will be administered by intravenous injection.

Other names: D

Saline

Drug

About 30min before the end of operation, Normal saline 0.5ml will be administered by intravenous injection.

Other names: S

Primary outcomes

  1. Incidence of delirium within 7 days after operation

    Time frame: 7 days after operation

    Incidence of delirium within 7 days after operation

Secondary outcomes

  1. Severity of delirium

    Time frame: From the end of operation to 7 days after opertation

    Severity of Postoperative delirium

  2. Delirium-free days

    Time frame: From the end of operation to 7 days after opertation

    Delirium-free days

  3. Postoperative hospital duration

    Time frame: From end of operation to discharge, an average of 1 week

    Postoperative hospital duration

  4. cognitive function at 30 days and 6 months

    Time frame: 30 days and 6 months after surgery

    cognitive function at 30 days and 6 months

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

Low-dose Droperidol for Prevention of Postoperative Delirium in Elderly Patients After Non-cardiac Surgery: A Randomized, Double-blind, Placebo-controlled Trial

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Jun 2, 2022
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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