Last updated: January 19, 2023
Sponsor: RenJi Hospital
Overall Status: Active - Recruiting
Phase
N/A
Condition
Orthopedic Surgery
Dementia
Orthopedics
Treatment
N/AClinical Study ID
NCT05401058
DECPOD-DP
Ages > 65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age≥65 years
- American Society of Anesthesiologists (ASA): I-III
- Planning to undergo elective non-cardiac surgery under general anesthesia withendotracheal intubation, including digestive, orthopedic, urologic and gynecologicalsurgery
- Estimated operation time more than 2 hours
- Not expected to be admitted to ICU postoperatively
- Proficient in Chinese
- Informed consent
Exclusion
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'sdisease, 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 gof strong Chinese spirits);
- Participating in conflicting clinical trials;
- Expected to have an additional operation within 7 days after the index operation.
Study Design
Total Participants: 2968
Study Start date:
November 21, 2022
Estimated Completion Date:
December 31, 2024
Connect with a study center
The first Affiliated Hospital of Anhui Medical University
Hefei, Anhui
ChinaSite Not Available
Henan Provincial People Hospital
Zhengzhou, Henan
ChinaSite Not Available
Renji Hospital, Shanghai Jiaotong University School of Medicine
Pudong, Shanghai 200127
ChinaActive - Recruiting
Second hospital of Shanxi Medical University
Taiyuan, Shanxi
ChinaSite Not Available
Sichuan Academy of Medical Sciences - Sichuan Provincial People's Hospital (SAMSPH)
Chengdu, Sichuan
ChinaSite Not Available
The First Affiliated Hospital of Chongqing Medical University
Chongqing,
ChinaSite Not Available
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