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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 31, 2024

Interventions

  • Drug: Droperidol Injection
    • About 30min before the end of operation, Droperidol 1.25mg/0.5ml will be administered by intravenous injection.
  • Drug: Saline
    • About 30min before the end of operation, Normal saline 0.5ml will be administered by intravenous injection.

Arms, Groups and Cohorts

  • Experimental: Experimental group
    • Droperidol 1.25mg/0.5ml
  • Placebo Comparator: Placebo group
    • Normal saline 0.5ml

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of delirium within 7 days after operation
    • Time Frame: 7 days after operation
    • Incidence of delirium within 7 days after operation

Secondary Measures

  • Severity of delirium
    • Time Frame: From the end of operation to 7 days after opertation
    • Severity of Postoperative delirium
  • Delirium-free days
    • Time Frame: From the end of operation to 7 days after opertation
    • Delirium-free days
  • Postoperative hospital duration
    • Time Frame: From end of operation to discharge, an average of 1 week
    • Postoperative hospital duration
  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 65 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • RenJi Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Diansan Su, MD,PHD, Principal Investigator, Renji Hospital, Shanghai Jiaotong University, School of Medcine
  • Overall Contact(s)
    • Diansan Su, MD,PHD, +8618616514088, diansansu@yahoo.com

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