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

• Study Type: Interventional
• Enrollment (Anticipated): 2968
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Diansan Su, MD,PHD; Phone Number: +8618616514088; Email: diansansu@yahoo.com

Study Locations

• China
  • Chongqing, China
    • Not yet recruiting
    • The First Affiliated Hospital of Chongqing Medical University
    • Contact: Ke Wei, PhD,MD
  • Anhui
    • Hefei, Anhui, China
      • Not yet recruiting
      • The First Affiliated Hospital of Anhui Medical University
      • Contact: Xuesheng Liu, MD,PHD; Phone Number: +8618655193385; Email: liuxuesheng@ahmu.edu.cn
  • Henan
    • Zhengzhou, Henan, China
      • Not yet recruiting
      • Henan Provincial People Hospital
      • Contact: Jiaqiang Zhang, MD,PHD; Phone Number: +8613937121360; Email: hnmzxh@163.com
  • Shanghai
    • Pudong, Shanghai, China, 200127
      • Recruiting
      • Renji Hospital, Shanghai Jiaotong University School of Medicine
      • Contact: Diansan Su, MD,PHD; Phone Number: +8618616514088; Email: diansansu@yahoo.com
  • Shanxi
    • Taiyuan, Shanxi, China
      • Not yet recruiting
      • Second Hospital of Shanxi Medical University
      • Contact: Linzhong Zhang, PHD,MD
  • Sichuan
    • Chengdu, Sichuan, China
      • Not yet recruiting
      • Sichuan Academy of Medical Sciences - Sichuan Provincial People's Hospital (SAMSPH)
      • Contact: Qian Lei, PHD,MD

Participation Criteria

Eligibility Criteria

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

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: Principal Investigator: Diansan Su, MD,PHD, Renji Hospital, Shanghai Jiaotong University, School of Medcine

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2022
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

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): January 23, 2023
• Last Update Submitted That Met QC Criteria: January 19, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: postoperative delirium; elderly patients; non-cardiac surgery; Droperidol
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Gastrointestinal Diseases; Digestive System Diseases; Urologic Diseases; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Dopamine Agents; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Adjuvants, Anesthesia; Droperidol
• 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