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

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

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.

Study Overview

• Status: Terminated
• Conditions: Urologic Diseases; Orthopedic Surgery; Digestive System Disease; Gynecological Disease
• Intervention / Treatment: Drug: Droperidol Injection; Drug: Saline

• Study Type: Interventional
• Enrollment (Actual): 797
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Cancer Hospital Chinese Academy of Medical Sciences
  • Beijing, China
    • Peking University International Hospital
  • Chongqing, China
    • The First Affiliated Hospital of Chongqing Medical University
  • Shanghai, China
    • Changhai Hospital
  • Anhui
    • Hefei, Anhui, China
      • The First Affiliated Hospital of Anhui Medical University
  • Henan
    • Zhengzhou, Henan, China
      • Henan Provincial People Hospital
  • Shanghai Municipality
    • Pudong, Shanghai Municipality, China, 200127
      • Renji Hospital, Shanghai Jiaotong University School of Medicine
  • Shanxi
    • Taiyuan, Shanxi, China
      • Second hospital of Shanxi Medical University
  • Sichuan
    • Chengdu, Sichuan, China
      • Sichuan Academy of Medical Sciences - Sichuan Provincial People's Hospital (SAMSPH)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Droperidol 1.25mg/0.5ml	Drug: Droperidol Injection; About 30min before the end of operation, Droperidol 1.25mg/0.5ml will be administered by intravenous injection.; Other Names: D
Placebo Comparator: Placebo group; Normal saline 0.5ml	Drug: Saline; About 30min before the end of operation, Normal saline 0.5ml will be administered by intravenous injection.; Other Names: S

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of delirium within 7 days after operation	Incidence of delirium within 7 days after operation	7 days after operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of delirium	Severity of Postoperative delirium	From the end of operation to 7 days after opertation
Delirium-free days	Delirium-free days	From the end of operation to 7 days after opertation
Postoperative hospital duration	Postoperative hospital duration	From end of operation to discharge, an average of 1 week
cognitive function at 30 days and 6 months	cognitive function at 30 days and 6 months	30 days and 6 months after surgery

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Investigators: Study Chair: Diansan Su, MD,PHD, First Affiliated Hospital of Zhejiang University; Principal Investigator: Ziyu Zhu, MD,PHD, Renji Hospital, Jiaotong University, School of medicine

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2022
• Primary Completion (Actual): December 20, 2024
• Study Completion (Actual): July 30, 2025

Study Registration Dates

• First Submitted: May 23, 2022
• First Submitted That Met QC Criteria: June 1, 2022
• First Posted (Actual): June 2, 2022

Study Record Updates

• Last Update Posted (Actual): August 12, 2026
• Last Update Submitted That Met QC Criteria: August 10, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: postoperative delirium; elderly patients; non-cardiac surgery; Droperidol
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Emergence Delirium; Digestive System Diseases; Urologic Diseases; Genital Diseases, Female; Organic Chemicals; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Inorganic Chemicals; Chlorine Compounds; Butyrophenones; Ketones; Sodium Compounds; Chlorides; Hydrochloric Acid; Droperidol; Sodium Chloride; Fumigant 93
• Other Study ID Numbers: DECPOD-DP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No