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

Study Overview
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Brief Summary
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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.

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

Conditions
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Digestive System Disease, Urologic Diseases, Gynecological Disease, Orthopedic Surgery

Intervention / Treatment
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* Drug: Droperidol Injection
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Droperidol 1.25mg/0.5ml | Drug: Droperidol Injection<br>* About 30min before the end of operation, Droperidol 1.25mg/0.5ml will be administered by intravenous injection.<br>* Other names: D;|
| Placebo Comparator: Placebo group<br>Normal saline 0.5ml | Drug: Saline<br>* About 30min before the end of operation, Normal saline 0.5ml will be administered by intravenous injection.<br>* Other names: S;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of delirium within 7 days after operation | Incidence of delirium within 7 days after operation | 7 days after operation | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-cardiac surgery, Droperidol, postoperative delirium, elderly patients