Digestive System DiseaseNCT05401058
Low-dose Droperidol for Prevention of Postoperative Delirium in Elderly Patients After Non-cardiac Surgery
A study testing Droperidol Injection and Saline in people with Digestive System Disease and Urologic Diseases, run by RenJi Hospital at 9 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Digestive System Disease, Urologic Diseases, Gynecological Disease
- What is being tested?
- Droperidol Injection and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 797 participants
- Where
- 9 sitesChina
- Study dates
- 21 Nov 2022to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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];
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- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites
Cancer Hospital Chinese Academy of Medical Sciences
Beijing
Peking University International Hospital
Beijing
Sichuan Academy of Medical Sciences - Sichuan Provincial People's Hospital (SAMSPH)
Chengdu, Sichuan
The First Affiliated Hospital of Chongqing Medical University
Chongqing
The first Affiliated Hospital of Anhui Medical University
Hefei, Anhui
Renji Hospital, Shanghai Jiaotong University School of Medicine
Pudong, Shanghai Municipality, 200127
ChangHai Hospital
Shanghai
Second hospital of Shanxi Medical University
Taiyuan, Shanxi
Henan Provincial People Hospital
Zhengzhou, Henan
About this study
Official title: Low-dose Droperidol for Prevention of Postoperative Delirium in Elderly Patients After Non-cardiac Surgery: A Randomized, Double-blind, Placebo-controlled Trial
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.
- Being tested
- Droperidol Injection, Saline
- Keywords
- non-cardiac surgery, Droperidol, postoperative delirium, elderly patients
- Medical subject headings
- Digestive System Diseases, Urologic Diseases, Genital Diseases, Female, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Droperidol InjectionDrug
Also called D
About 30min before the end of operation, Droperidol 1.25mg/0.5ml will be administered by intravenous injection.
SalineDrug
Also called S
About 30min before the end of operation, Normal saline 0.5ml will be administered by intravenous injection.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Droperidol 1.25mg/0.5ml Receives: Drug: Droperidol Injection |
| Placebo group | Placebo comparator | Normal saline 0.5ml Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of delirium within 7 days after operation
Incidence of delirium within 7 days after operation
Measured: 7 days after operation
Secondary outcomes (4)
Severity of delirium
Severity of Postoperative delirium
Measured: From the end of operation to 7 days after opertation
Delirium-free days
Delirium-free days
Measured: From the end of operation to 7 days after opertation
Postoperative hospital duration
Postoperative hospital duration
Measured: From end of operation to discharge, an average of 1 week
cognitive function at 30 days and 6 months
cognitive function at 30 days and 6 months
Measured: 30 days and 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start21 Nov 2022
- Primary completion20 Dec 2024
- Study completion30 Jul 2025
Why it stopped: The trial was terminated on the independent DSMB's recommendation after an interim analysis showed no evidence of benefit and a numerically higher incidence of postoperative delirium in the droperidol group, raising a potential safety concern.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestive System DiseaseStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 797 participants (actual)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diansan Su, MD,PHD, Study chair, First Affiliated Hospital of Zhejiang UniversityZiyu Zhu, MD,PHD, Principal investigator, Renji Hospital, Jiaotong University, School of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05401058
- Sponsor's protocol ID
- DECPOD-DP
- Status last verified
- Aug 2026
- First submitted
- 23 May 2022
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-dose Droperidol for Prevention of Postoperative Delirium in Elderly Patients After Non-cardiac Surgery: A Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT05401058
- Acronym / sponsor ID
- DECPOD-DP
- Keywords
- non-cardiac surgery, Droperidol, postoperative delirium, elderly patients
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The trial was terminated on the independent DSMB's recommendation after an interim analysis showed no evidence of benefit and a numerically higher incidence of postoperative delirium in the droperidol group, raising a potential safety concern.
- Enrolment
- 797 participants (actual)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 21 Nov 2022 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 2 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Droperidol InjectionDroperidol 1.25mg/0.5ml |
| Placebo group | Placebo comparator | Drug: SalineNormal saline 0.5ml |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Droperidol InjectionAlso: DAbout 30min before the end of operation, Droperidol 1.25mg/0.5ml will be administered by intravenous injection. | Drug | Experimental group |
| SalineAlso: SAbout 30min before the end of operation, Normal saline 0.5ml will be administered by intravenous injection. | Drug | Placebo group |
Primary outcome
Incidence of delirium within 7 days after operation
Time frame: 7 days after operation
Incidence of delirium within 7 days after operation
4 secondary outcomes
Severity of delirium
Time frame: From the end of operation to 7 days after opertation
Delirium-free days
Time frame: From the end of operation to 7 days after opertation
Postoperative hospital duration
Time frame: From end of operation to discharge, an average of 1 week
cognitive function at 30 days and 6 months
Time frame: 30 days and 6 months after surgery
Results and safety
The study was stopped early (reason given: The trial was terminated on the independent DSMB's recommendation after an interim analysis showed no evidence of benefit and a numerically higher incidence of postoperative delirium in the droperidol group, raising a potential safety concern.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diansan Su, MD,PHD study chair
First Affiliated Hospital of Zhejiang University
Ziyu Zhu, MD,PHD principal investigator
Renji Hospital, Jiaotong University, School of medicine
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Droperidol Injection and Saline in people with Digestive System Disease and Urologic Diseases, run by RenJi Hospital at 9 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The trial was terminated on the independent DSMB's recommendation after an interim analysis showed no evidence of benefit and a numerically higher incidence of postoperative delirium in the droperidol group, raising a potential safety concern.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of delirium within 7 days after operation (time frame: 7 days after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.