Status:
UNKNOWN
Low-dose Droperidol for Prevention of Postoperative Delirium in Elderly Patients After Non-cardiac Surgery
Lead Sponsor:
RenJi Hospital
Conditions:
Digestive System Disease
Urologic Diseases
Eligibility:
All Genders
65+ years
Phase:
NA
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 surger...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
2968 Patients enrolled
Trial Details
Trial ID
NCT05401058
Start Date
November 21 2022
End Date
December 31 2024
Last Update
January 23 2023
Active Locations (6)
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1
The first Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
2
Henan Provincial People Hospital
Zhengzhou, Henan, China
3
Renji Hospital, Shanghai Jiaotong University School of Medicine
Pudong, Shanghai Municipality, China, 200127
4
Second hospital of Shanxi Medical University
Taiyuan, Shanxi, China