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

Last updated: January 19, 2023
Sponsor: RenJi Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Orthopedic Surgery

Dementia

Orthopedics

Treatment

N/A

Clinical Study ID

NCT05401058
DECPOD-DP
  • Ages > 65
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age≥65 years
  • American Society of Anesthesiologists (ASA): I-III
  • Planning to undergo elective non-cardiac surgery under general anesthesia withendotracheal intubation, including digestive, orthopedic, urologic and gynecologicalsurgery
  • Estimated operation time more than 2 hours
  • Not expected to be admitted to ICU postoperatively
  • Proficient in Chinese
  • Informed consent

Exclusion

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'sdisease, 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 gof strong Chinese spirits);
  • Participating in conflicting clinical trials;
  • Expected to have an additional operation within 7 days after the index operation.

Study Design

Total Participants: 2968
Study Start date:
November 21, 2022
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • The first Affiliated Hospital of Anhui Medical University

    Hefei, Anhui
    China

    Site Not Available

  • Henan Provincial People Hospital

    Zhengzhou, Henan
    China

    Site Not Available

  • Renji Hospital, Shanghai Jiaotong University School of Medicine

    Pudong, Shanghai 200127
    China

    Active - Recruiting

  • Second hospital of Shanxi Medical University

    Taiyuan, Shanxi
    China

    Site Not Available

  • Sichuan Academy of Medical Sciences - Sichuan Provincial People's Hospital (SAMSPH)

    Chengdu, Sichuan
    China

    Site Not Available

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing,
    China

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.