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

Shanghai Jiao Tong University logo

Shanghai Jiao Tong University

Status

Enrolling

Conditions

Orthopedic Surgery
Gynecological Disease
Digestive System Disease
Urologic Diseases

Treatments

Drug: Droperidol Injection
Drug: Saline

Study type

Interventional

Funder types

Other

Identifiers

NCT05401058
DECPOD-DP

Details and patient eligibility

About

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.

Enrollment

2,968 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

2,968 participants in 2 patient groups, including a placebo group

Experimental group
Experimental group
Description:
Droperidol 1.25mg/0.5ml
Treatment:
Drug: Droperidol Injection
Placebo group
Placebo Comparator group
Description:
Normal saline 0.5ml
Treatment:
Drug: Saline

Trial contacts and locations

6

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Central trial contact

Diansan Su, MD,PHD

Data sourced from clinicaltrials.gov

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