NCT05401058TerminatedNot Applicable
Low-dose Droperidol for Prevention of Postoperative Delirium in Elderly Patients After Non-cardiac Surgery: A Randomized, Double-blind, Placebo-controlled Trial
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- RenJi Hospital
- Enrollment
- 797
- Locations
- 9
- Primary Endpoint
- Incidence of delirium within 7 days after operation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Placebo group
Placebo Comparator
Normal saline 0.5ml
Intervention: Saline (Drug)
Experimental group
Experimental
Droperidol 1.25mg/0.5ml
Intervention: Droperidol Injection (Drug)
Outcomes
Primary Outcomes
Incidence of delirium within 7 days after operation
Time Frame: 7 days after operation
Incidence of delirium within 7 days after operation
Secondary Outcomes
- Postoperative hospital duration(From end of operation to discharge, an average of 1 week)
- Severity of delirium(From the end of operation to 7 days after opertation)
- Delirium-free days(From the end of operation to 7 days after opertation)
- cognitive function at 30 days and 6 months(30 days and 6 months after surgery)
Investigators
Study Sites (9)
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