Stomach NeoplasmsPhase 4NCT05068180
Low-dose Neuroleptanalgesia for Postoperative Delirium in Elderly Patients
A Phase 4 study testing low-dose neuroleptanalgesia in people with Stomach Neoplasms and Colonic Neoplasms, run by RenJi Hospital at 2 sites in China.
Trial summary
Postoperative delirium（POD）is a common complication that can directly affect important clinical outcomes, and exert an enormous burden on patients, their families, hospitals, and public resources. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Stomach Neoplasms, Colonic Neoplasms, Rectal Neoplasms
- What is being tested?
- low-dose neuroleptanalgesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 2 sitesChina
- Study dates
- 5 Oct 2021to 10 Apr 2022
- Phase
- Phase 4
- 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 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 65 years old and ≤ 85 years old;
- Selective non-cardiac major surgery;
- Informed consent and voluntary participation in the trial;
- ASA class I-II;
- Anticipated operation duration ≥ 2 hours;
- No plan to ICU after operation.
Who cannot join
- Neurosurgery;
- Patients with neurological and mental diseases: such as basal ganglia disease, Parkinson's syndrome, severe central nervous depression, Alzheimer's disease , etc;
- Patients with prolonged Q-T interval, cardiac repolarization disorder and other severe arrhythmia;
- Patients with severe cardiopulmonary disease, liver and kidney dysfunction;
- Allergic or contraindications to droperidol or fentanyl citrate;
- Admitted to ICU after operation.
- Operation duration < 2 hours;
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127
Zhenling Huang, Doctor, 18964381971, 2993252569@qq.com
Xiao Zhang, MS, 18317087118, fdzhangxiao@126.com
- Not yet recruiting
Shanghai Eighth People's Hospital
Shanghai, Shanghai Municipality
Cuixia Song, BS, 13817874048, songcuixia2001@126.com
About this study
Official title: Low-dose Neuroleptanalgesia Reduce the Occurrences of Postoperative Delirium in Elderly Patients Undergoing Non-cardiac Major Surgery : a Randomized Controlled Trial
Postoperative delirium（POD）is a common complication that can directly affect important clinical outcomes, and exert an enormous burden on patients, their families, hospitals, and public resources. In order to evaluate whether an intraoperative administration of low-dose neuroleptanalgesia reduces postoperative delirium, droperidol 1.25 mg and fentanyl 0.025 mg or normal saline is used by intravenous injection 30 minutes before the end of the operation, in elderly patients with non-cardiac major surgery under general anesthesia. The efficiency and safety of neuroleptanalgesia on the incidence of POD would be evaluated in elderly patients.
- Conditions
- Stomach Neoplasms, Colonic Neoplasms, Rectal Neoplasms, Sigmoid Neoplasms, Liver Neoplasms, Kidney Neoplasms
- Being tested
- low-dose neuroleptanalgesia, Placebo
- Keywords
- Postoperative delirium, Neuroleptanalgesia, Aged, Noncardiac major surgery
- Medical subject headings
- Stomach Neoplasms, Colonic Neoplasms, Rectal Neoplasms, Sigmoid Neoplasms, Liver Neoplasms, Kidney Neoplasms, Urinary Bladder Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-dose neuroleptanalgesiaDrug
Droperidol 1.25 mg and fentanyl 0.025 mg (diluted with normal saline up to 5ml) is to be administrated intravenously 30 minutes before the end of the procedure.
PlaceboDrug
The same volume of normal saline is to be administrated intravenously 30 minutes before the end of the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Neuroleptanalgesia group | Experimental | Droperidol 1.25 mg and fentanyl 0.025 mg (diluted with normal saline up to 5ml) is to be administrated intravenously 30 minutes before the end of the procedure. Receives: Drug: low-dose neuroleptanalgesia |
| Control group | Placebo comparator | The same volume of normal saline is to be administrated intravenously 30 minutes before the end of the procedure. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidences of POD after general anesthesia in elderly patients undergoing non-cardiac major surgery
Measured: Up to 7 days after surgery（or leaving hospital）
Secondary outcomes (6)
Length of hospital stay
Measured: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Incidence of postoperative nausea and vomiting
Measured: Up to 7 days after surgery（or leaving hospital）
Patients' satisfaction
This outcome will be measured using a numeric rating scale from 1 ( dissatisfaction ) to 3 (very satisfied)
Measured: Up to 7 days after surgery（or leaving hospital）
Incidence of postoperative hypoxia
Measured: Up to 1 day after surgery
Incidence of major serious complications and serious arrhythmia
Measured: Up to 7 days after surgery（or leaving hospital）
Duration of postoperative delirium
Measured: Up to 7 days after surgery（or leaving hospital）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2021
- Study start5 Oct 2021
- Primary completion10 Apr 2022 (estimated)
- Study completion10 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach NeoplasmsStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai 8th People's Hospital
- Responsible party
- Sponsor
- Investigators
- Diansan Su, Doctor, Study chair, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05068180
- Sponsor's protocol ID
- KY2020-125
- Status last verified
- Oct 2021
- First submitted
- 6 Sep 2021
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-dose Neuroleptanalgesia Reduce the Occurrences of Postoperative Delirium in Elderly Patients Undergoing Non-cardiac Major Surgery : a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05068180
- Acronym / sponsor ID
- KY2020-125
- Conditions
- Stomach Neoplasms, Colonic Neoplasms, Rectal Neoplasms, Sigmoid Neoplasms, Liver Neoplasms, Kidney Neoplasms
- Keywords
- Postoperative delirium, Neuroleptanalgesia, Aged, Noncardiac major surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Shanghai 8th People's Hospital
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- 10 Apr 2022 (estimated)
- Study completion
- 10 Apr 2022 (estimated)
- First posted
- 5 Oct 2021 (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.
Postoperative delirium（POD）is a common complication that can directly affect important clinical outcomes, and exert an enormous burden on patients, their families, hospitals, and public resources. In order to evaluate whether an intraoperative administration of low-dose neuroleptanalgesia reduces postoperative delirium, droperidol 1.25 mg and fentanyl 0.025 mg or normal saline is used by intravenous injection 30 minutes before the end of the operation, in elderly patients with non-cardiac major surgery under general anesthesia. The efficiency and safety of neuroleptanalgesia on the incidence of POD would be evaluated in elderly patients.
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 |
|---|---|---|
| Neuroleptanalgesia group | Experimental | Drug: low-dose neuroleptanalgesiaDroperidol 1.25 mg and fentanyl 0.025 mg (diluted with normal saline up to 5ml) is to be administrated intravenously 30 minutes before the end of the procedure. |
| Control group | Placebo comparator | Drug: PlaceboThe same volume of normal saline is to be administrated intravenously 30 minutes before the end of the procedure. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Age ≥ 65 years old and ≤ 85 years old;
- Selective non-cardiac major surgery;
- Informed consent and voluntary participation in the trial;
- ASA class I-II;
- Anticipated operation duration ≥ 2 hours;
Key exclusion criteria (7 listed)
- Neurosurgery;
- Patients with neurological and mental diseases: such as basal ganglia disease, Parkinson's syndrome, severe central nervous depression, Alzheimer's disease , etc;
- Patients with prolonged Q-T interval, cardiac repolarization disorder and other severe arrhythmia;
- Patients with severe cardiopulmonary disease, liver and kidney dysfunction;
- Allergic or contraindications to droperidol or fentanyl citrate;
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 |
|---|---|---|
| low-dose neuroleptanalgesiaDroperidol 1.25 mg and fentanyl 0.025 mg (diluted with normal saline up to 5ml) is to be administrated intravenously 30 minutes before the end of the procedure. | Drug | Neuroleptanalgesia group |
| PlaceboThe same volume of normal saline is to be administrated intravenously 30 minutes before the end of the procedure. | Drug | Control group |
Primary outcome
Incidences of POD after general anesthesia in elderly patients undergoing non-cardiac major surgery
Time frame: Up to 7 days after surgery（or leaving hospital）
6 secondary outcomes
Length of hospital stay
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days
Incidence of postoperative nausea and vomiting
Time frame: Up to 7 days after surgery（or leaving hospital）
Patients' satisfaction
Time frame: Up to 7 days after surgery（or leaving hospital）
Incidence of postoperative hypoxia
Time frame: Up to 1 day after surgery
Incidence of major serious complications and serious arrhythmia
Time frame: Up to 7 days after surgery（or leaving hospital）
Duration of postoperative delirium
Time frame: Up to 7 days after surgery（or leaving hospital）
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
- Individual participant dataSharing planned: No
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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, Doctor study chair
RenJi Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing low-dose neuroleptanalgesia in people with Stomach Neoplasms and Colonic Neoplasms, run by RenJi Hospital at 2 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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diansan Su, Doctor (18616514088, 184872238@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidences of POD after general anesthesia in elderly patients undergoing non-cardiac major surgery (time frame: Up to 7 days after surgery（or leaving hospital）). 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 6 Oct 2021.