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

Urologic Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05401058
• Other study ID #: DECPOD-DP
• Status: Recruiting
• Phase: N/A
• Start date: November 21, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2023
• Source: RenJi Hospital
• Contact: Diansan Su, MD,PHD
• Phone: +8618616514088
• Email: diansansu[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2968
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Delirium
• Digestive System Disease
• Digestive System Diseases
• Gastrointestinal Diseases
• Gynecological Disease
• Orthopedic Surgery
• Urologic Diseases

Intervention

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

Locations

Country	Name	City	State
China	Sichuan Academy of Medical Sciences - Sichuan Provincial People's Hospital (SAMSPH)	Chengdu	Sichuan
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing
China	The first Affiliated Hospital of Anhui Medical University	Hefei	Anhui
China	Renji Hospital, Shanghai Jiaotong University School of Medicine	Pudong	Shanghai
China	Second hospital of Shanxi Medical University	Taiyuan	Shanxi
China	Henan Provincial People Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of delirium within 7 days after operation	Incidence of delirium within 7 days after operation	7 days after operation
Secondary	Severity of delirium	Severity of Postoperative delirium	From the end of operation to 7 days after opertation
Secondary	Delirium-free days	Delirium-free days	From the end of operation to 7 days after opertation
Secondary	Postoperative hospital duration	Postoperative hospital duration	From end of operation to discharge, an average of 1 week
Secondary	cognitive function at 30 days and 6 months	cognitive function at 30 days and 6 months	30 days and 6 months after surgery