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

Not Applicable

Recruiting

• Conditions: Digestive System Disease; Gynecological Disease; Urologic Diseases; Orthopedic Surgery
• Interventions: Drug: Saline; Drug: Droperidol Injection

• Registration Number: NCT05401058
• Lead Sponsor: RenJi Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-23
• Study First Submitted QC: 2022-06-01
• Study First Posted: 2022-06-02
• Study Start: 2022-11-21
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-19
• Last Update Posted: 2023-01-23
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2968

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Saline	Normal saline 0.5ml
Experimental group	Droperidol Injection	Droperidol 1.25mg/0.5ml

Primary Outcome Measures

Name	Time	Method
Incidence of delirium within 7 days after operation	7 days after operation	Incidence of delirium within 7 days after operation

Secondary Outcome Measures

Name	Time	Method
Postoperative hospital duration	From end of operation to discharge, an average of 1 week	Postoperative hospital duration
Severity of delirium	From the end of operation to 7 days after opertation	Severity of Postoperative delirium
Delirium-free days	From the end of operation to 7 days after opertation	Delirium-free days
cognitive function at 30 days and 6 months	30 days and 6 months after surgery	cognitive function at 30 days and 6 months

Trial Locations

Locations (6)

The first Affiliated Hospital of Anhui Medical University; 🇨🇳 Hefei, Anhui, China

Henan Provincial People Hospital; 🇨🇳 Zhengzhou, Henan, China

Renji Hospital, Shanghai Jiaotong University School of Medicine; 🇨🇳 Pudong, Shanghai, China

Sichuan Academy of Medical Sciences - Sichuan Provincial People's Hospital (SAMSPH); 🇨🇳 Chengdu, Sichuan, China

Second hospital of Shanxi Medical University; 🇨🇳 Taiyuan, Shanxi, China

The First Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, China