Digestive System Disease, Gynecological Disease, Orthopedic Surgery, Urologic Diseases
Conditions
Keywords
non-cardiac surgery, Droperidol, postoperative delirium, elderly patients
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.
Interventions
About 30min before the end of operation, Droperidol 1.25mg/0.5ml will be administered by intravenous injection.
DRUGSaline
About 30min before the end of operation, Normal saline 0.5ml will be administered by intravenous injection.
Sponsors
RenJi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of delirium within 7 days after operation | 7 days after operation | Incidence of delirium within 7 days after operation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Postoperative hospital duration | From end of operation to discharge, an average of 1 week | Postoperative hospital duration |
| cognitive function at 30 days and 6 months | 30 days and 6 months after surgery | cognitive function at 30 days and 6 months |
Countries
China
Contacts
STUDY_CHAIRDiansan Su, MD,PHD
First Affiliated Hospital of Zhejiang University
PRINCIPAL_INVESTIGATORZiyu Zhu, MD,PHD
Renji Hospital, Jiaotong University, School of medicine
Outcome results
None listed