Back to resultsLow-dose Droperidol for Prevention of Postoperative Delirium in Elderly Patients After Non-cardiac Surgery
Primary Purpose
Digestive System Disease, Urologic Diseases, Gynecological Disease
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Droperidol Injection
Saline
Sponsored by
About this trial
This is an interventional prevention trial for Digestive System Disease focused on measuring non-cardiac surgery, Droperidol, postoperative delirium, elderly patients
Eligibility Criteria
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.
Sites / Locations
- The first Affiliated Hospital of Anhui Medical University
- Henan Provincial People Hospital
- Renji Hospital, Shanghai Jiaotong University School of MedicineRecruiting
- Second hospital of Shanxi Medical University
- Sichuan Academy of Medical Sciences - Sichuan Provincial People's Hospital (SAMSPH)
- The First Affiliated Hospital of Chongqing Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental group
Placebo group
Arm Description
Droperidol 1.25mg/0.5ml
Normal saline 0.5ml
Outcomes
Primary Outcome Measures
Incidence of delirium within 7 days after operation
Incidence of delirium within 7 days after operation
Secondary Outcome Measures
Severity of delirium
Severity of Postoperative delirium
Delirium-free days
Delirium-free days
Postoperative hospital duration
Postoperative hospital duration
cognitive function at 30 days and 6 months
cognitive function at 30 days and 6 months
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05401058
Brief Title
Low-dose Droperidol for Prevention of Postoperative Delirium in Elderly Patients After Non-cardiac Surgery
Official Title
Low-dose Droperidol for Prevention of Postoperative Delirium in Elderly Patients After Non-cardiac Surgery: A Randomized, Double-blind, Placebo-controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 21, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RenJi Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Digestive System Disease, Urologic Diseases, Gynecological Disease, Orthopedic Surgery
Keywords
non-cardiac surgery, Droperidol, postoperative delirium, elderly patients
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2968 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Droperidol 1.25mg/0.5ml
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Normal saline 0.5ml
Intervention Type
Drug
Intervention Name(s)
Droperidol Injection
Other Intervention Name(s)
D
Intervention Description
About 30min before the end of operation, Droperidol 1.25mg/0.5ml will be administered by intravenous injection.
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
S
Intervention Description
About 30min before the end of operation, Normal saline 0.5ml will be administered by intravenous injection.
Primary Outcome Measure Information:
Title
Incidence of delirium within 7 days after operation
Description
Incidence of delirium within 7 days after operation
Time Frame
7 days after operation
Secondary Outcome Measure Information:
Title
Severity of delirium
Description
Severity of Postoperative delirium
Time Frame
From the end of operation to 7 days after opertation
Title
Delirium-free days
Description
Delirium-free days
Time Frame
From the end of operation to 7 days after opertation
Title
Postoperative hospital duration
Description
Postoperative hospital duration
Time Frame
From end of operation to discharge, an average of 1 week
Title
cognitive function at 30 days and 6 months
Description
cognitive function at 30 days and 6 months
Time Frame
30 days and 6 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diansan Su, MD,PHD
Phone
+8618616514088
Email
diansansu@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diansan Su, MD,PHD
Organizational Affiliation
Renji Hospital, Shanghai Jiaotong University, School of Medcine
Official's Role
Principal Investigator
Facility Information:
Facility Name
The first Affiliated Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuesheng Liu, MD,PHD
Phone
+8618655193385
Email
liuxuesheng@ahmu.edu.cn
Facility Name
Henan Provincial People Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiaqiang Zhang, MD,PHD
Phone
+8613937121360
Email
hnmzxh@163.com
Facility Name
Renji Hospital, Shanghai Jiaotong University School of Medicine
City
Pudong
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diansan Su, MD,PhD
Phone
+8618616514088
Email
diansansu@yahoo.com
Facility Name
Second hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linzhong Zhang, PHD,MD
Facility Name
Sichuan Academy of Medical Sciences - Sichuan Provincial People's Hospital (SAMSPH)
City
Chengdu
State/Province
Sichuan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qian Lei, PHD,MD
Facility Name
The First Affiliated Hospital of Chongqing Medical University
City
Chongqing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ke Wei, PhD,MD
12. IPD Sharing Statement
Learn more about this trial
Low-dose Droperidol for Prevention of Postoperative Delirium in Elderly Patients After Non-cardiac Surgery
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