Clinical trial NCT05401058: Low-dose Droperidol for Prevention of Postoperative Delirium in Elderly Patients After Non-cardiac Surgery
Official title: Low-dose Droperidol for Prevention of Postoperative Delirium in Elderly Patients After Non-cardiac Surgery: A Randomized, Double-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Digestive System Disease
Urologic Diseases
Gynecological Disease
Orthopedic Surgery
Keywords: non-cardiac surgery
Droperidol
postoperative delirium
elderly patients
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2022-06-02
Enrollment: 2968
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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.

Primary outcomes:
measure: Incidence of delirium within 7 days after operation
timeFrame: 7 days after operation
Secondary outcomes:
measure: Severity of delirium
timeFrame: From the end of operation to 7 days after opertation
measure: Delirium-free days
timeFrame: From the end of operation to 7 days after opertation
measure: Postoperative hospital duration
timeFrame: From end of operation to discharge, an average of 1 week
measure: cognitive function at 30 days and 6 months
timeFrame: 30 days and 6 months after surgery
Other outcomes:
Locations:
city: Hefei
country: China
facility: The first Affiliated Hospital of Anhui Medical University
state: Anhui
city: Zhengzhou
country: China
facility: Henan Provincial People Hospital
state: Henan
city: Pudong
country: China
facility: Renji Hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Taiyuan
country: China
facility: Second hospital of Shanxi Medical University
state: Shanxi
city: Chengdu
country: China
facility: Sichuan Academy of Medical Sciences - Sichuan Provincial People's Hospital (SAMSPH)
state: Sichuan
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
Study officials:
affiliation: Renji Hospital, Shanghai Jiaotong University, School of Medcine
name: Diansan Su, MD,PHD
role: PRINCIPAL_INVESTIGATOR
References: