InjectionNCT05242419
A Study of Huperzine A Injection in Reducing Postoperative Delirium in Elderly Patients Undergoing Non-cardiac Surgery
A study testing Sodium Chloride Injection and Huperzine A Injection in people with Injection and Non-cardiac Surgery, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
To observe and study the clinical effect of Huperzine A Injection on reducing postoperative delirium in elderly patients undergoing non-cardiac surgery Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Injection, Non-cardiac Surgery, Delirium in Old Age
- What is being tested?
- Sodium Chloride Injection and Huperzine A Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 10 Jun 2022to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- ≥ 75 years old.
- Comply with the indication of non-cardiac surgery under general anesthesia.
- Anesthesia grade of American Society of Anesthesiologist (ASA) as III~IV grade.
- The estimated operation time ≥ 2 hours.
- Voluntarily sign the informed consent form.
Who cannot join
- Patients with impaired renal function (Cr is 1.5 times higher than the upper limit of the normal value of the central laboratory) or abnormal liver function (Alanine aminotransferase(ALT) and Aspartate aminotransferase(AST) are 2 times higher than the upper limit of the normal value of the central laboratory).
- Patients who are positive for infectious diseases.
- Patients accompanied with central nervous system injury.
- Patients with previous history of delirium and epilepsy, long-term use of psychoactive drugs or preoperative assessment of delirium.
- Patients who involved diseases with drug taboos, bronchial asthma, mechanical intestinal obstruction and urinary tract obstruction, or serious systemic diseases, especially circulatory diseases: such as myocardial infarction, heart failure, angina pectoris, history of sinus bradycardia.
- Patients who are known to be allergic to narcotic drugs or Huperzine A Injection, or must use drugs that are not compatible with Huperzine An Injection.
- patients who participated in other clinical trials within 3 months before this study, for any reason, who could not tolerate the test or cooperate with the examination, or who has any aphasia, audio-visual dysfunction, etc.
- the investigators think that the patients is not suitable to participate in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The 2nd Second Affiliated Hospital of WMU Phase I Clinical Trial Unit /Center Of Bioequivalence Study
Wenzhou, Zhejiang, 325000
TING LI, 057785676822, feclinicalresearch@163.com
About this study
Official title: A Multi-center, Randomized, Double-blinded, Placebo-controlled Study of Huperzine A Injection in Reducing Postoperative Delirium in Elderly Patients Undergoing Non-cardiac Surgery
To observe and study the clinical effect of Huperzine A Injection on reducing postoperative delirium in elderly patients undergoing non-cardiac surgery
- Being tested
- Sodium Chloride Injection, Huperzine A Injection
- Keywords
- Huperzine A Injection, postoperative delirium, Non-cardiac Surgery, Elderly Patients
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Chloride InjectionDrug
0.9% Sodium Chloride Injection
Huperzine A InjectionDrug
Huperzine A Injection
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Huperzine A Injection Receives: Drug: Huperzine A Injection |
| Control group | Placebo comparator | 0.9% Sodium Chloride Injection Receives: Drug: Sodium Chloride Injection |
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
Delirium will be evaluated by The 3-dimensional Confusion Assessment Method(3D-CAM) and delirium rating scale-revised-98(DRS-R-98) scale form.
Measured: 7 days after operation
Secondary outcomes (9)
type of delirium
diagnosed by delirium rating scale-revised-98(DRS-R-98) scale form
Measured: evaluated at screening, 24 hours, 48 hours, 72 hours after operation
severity of delirium
diagnosed by delirium rating scale-revised-98(DRS-R-98) scale form
Measured: evaluated at screening, 24 hours, 48 hours, 72 hours after operation
duration of delirium
diagnosed by delirium rating scale-revised-98(DRS-R-98) scale form
Measured: evaluated at screening, 24 hours, 48 hours, 72 hours after operation
length of hospital stay
total number of days of hospital stay
Measured: from the day of operation to the day of discharge, around 7 to 14 days
Economic indicators (total hospitalization cost, anesthesia cost, operation cost).
costs at hospital
Measured: through study completion, up to 2 months
Occurrence of complications
pulmonary infection, myocardial infarction, renal failure, gastrointestinal bleeding, etc.
Measured: through study completion, up to 2 months
Incidence of Mortality
rate of Mortality during the hospital stay and follow-up within 30 days after discharge
Measured: the day of hospital discharge, and the day of follow-up, around 30 days after discharge
the total score of Mini-mental State Examination scale
Mini-mental State Examination scale
Measured: evaluated at screening, 72 hours after operation, and the day of follow-up, around 30 days after discharge
the score of EuroQol (EQ-5D) scale
EQ-5D scale
Measured: 96 hours after operation, the day of hospital discharge, and the day of follow-up, around 30 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start10 Jun 2022
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InjectionStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical UniversityThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Affiliated Wenling Hospital of Wenzhou Medical University
- Responsible party
- Principal investigator, Ting Li, Second Affiliated Hospital of Wenzhou Medical University
- Investigators
- Ting Li, MD. PhD, Principal investigator, Second Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05242419
- Sponsor's protocol ID
- SSJJZ-WW-01
- Status last verified
- Mar 2025
- First submitted
- 9 Jan 2022
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blinded, Placebo-controlled Study of Huperzine A Injection in Reducing Postoperative Delirium in Elderly Patients Undergoing Non-cardiac Surgery
- ClinicalTrials.gov ID
- NCT05242419
- Acronym / sponsor ID
- SSJJZ-WW-01
- Keywords
- Huperzine A Injection, postoperative delirium, Non-cardiac Surgery, Elderly Patients
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Collaborators
- Affiliated Wenling Hospital of Wenzhou Medical University
- Study start
- 10 Jun 2022 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 16 Feb 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.
To observe and study the clinical effect of Huperzine A Injection on reducing postoperative delirium in elderly patients undergoing non-cardiac surgery
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Huperzine A InjectionHuperzine A Injection |
| Control group | Placebo comparator | Drug: Sodium Chloride Injection0.9% Sodium Chloride Injection |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- ≥ 75 years old.
- Comply with the indication of non-cardiac surgery under general anesthesia.
- Anesthesia grade of American Society of Anesthesiologist (ASA) as III~IV grade.
- The estimated operation time ≥ 2 hours.
- Voluntarily sign the informed consent form.
Key exclusion criteria (8 listed)
- Patients with impaired renal function (Cr is 1.5 times higher than the upper limit of the normal value of the central laboratory) or abnormal liver function (Alanine aminotransferase(ALT) and Aspartate aminotransferase(AST) are 2 times higher than the upper limit of the normal value of the central laboratory).
- Patients who are positive for infectious diseases.
- Patients accompanied with central nervous system injury.
- Patients with previous history of delirium and epilepsy, long-term use of psychoactive drugs or preoperative assessment of delirium.
- Patients who involved diseases with drug taboos, bronchial asthma, mechanical intestinal obstruction and urinary tract obstruction, or serious systemic diseases, especially circulatory diseases: such as myocardial infarction, heart failure, angina pectoris, history of sinus bradycardia.
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 |
|---|---|---|
| Sodium Chloride Injection0.9% Sodium Chloride Injection | Drug | Control group |
| Huperzine A InjectionHuperzine A Injection | Drug | Treatment group |
Primary outcome
Incidence of delirium within 7 days after operation
Time frame: 7 days after operation
Delirium will be evaluated by The 3-dimensional Confusion Assessment Method(3D-CAM) and delirium rating scale-revised-98(DRS-R-98) scale form.
9 secondary outcomes
type of delirium
Time frame: evaluated at screening, 24 hours, 48 hours, 72 hours after operation
severity of delirium
Time frame: evaluated at screening, 24 hours, 48 hours, 72 hours after operation
duration of delirium
Time frame: evaluated at screening, 24 hours, 48 hours, 72 hours after operation
length of hospital stay
Time frame: from the day of operation to the day of discharge, around 7 to 14 days
Economic indicators (total hospitalization cost, anesthesia cost, operation cost).
Time frame: through study completion, up to 2 months
Occurrence of complications
Time frame: through study completion, up to 2 months
Incidence of Mortality
Time frame: the day of hospital discharge, and the day of follow-up, around 30 days after discharge
the total score of Mini-mental State Examination scale
Time frame: evaluated at screening, 72 hours after operation, and the day of follow-up, around 30 days after discharge
the score of EuroQol (EQ-5D) scale
Time frame: 96 hours after operation, the day of hospital discharge, and the day of follow-up, around 30 days after discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- 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.
Ting Li, MD. PhD principal investigator
Second Affiliated Hospital of Wenzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium Chloride Injection and Huperzine A Injection in people with Injection and Non-cardiac Surgery, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site 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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ting Li, MD. PhD (13587876896, liting1021@aliyun.com), or a site near the patient. 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 2 Apr 2025.