PNDPhase 4NCT07895407
Effects of Ciprofol on Perioperative Neurocognitive Function in Elderly Patients Undergoing Daytime Surgery
A Phase 4 study testing Ciprofol and propofol in people with PND and POCD - Postoperative Cognitive Dysfunction, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
As life expectancy increases, the rate of disability among elderly individuals is also rising. Elderly patients undergoing home-based rehabilitation after surgery without medical supervision may experience complications and adverse events such as nausea, vomiting, or bleeding, which can impair recovery of daily living… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- PND, POCD - Postoperative Cognitive Dysfunction
- What is being tested?
- Ciprofol and propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteChina
- Study dates
- 25 Apr 2025to 30 Jun 2027
- Phase
- Phase 4
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age ≥ 65 years
- ASA I-II grade or ASA III grade, with stable coexisting diseases for more than 3 months, and after strict assessment and preparation for optimization.
Who cannot join
- Acute central nervous system injury
- Diseases with drug contraindications or severe lesions in important organs such as the heart, brain, lungs, etc.
- Severe liver or kidney dysfunction
- History of schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis or other mental disorders in the past
- History of alcoholism and/or drug abuse
- Total intraoperative hypotension time ≥ 10 minutes or hypoxemia occurred
- No responsible adult accompanying the patient 24 hours after discharge
- Patients with poor language expression ability or unwillingness to follow the protocol or perform the procedures 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
Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
About this study
As life expectancy increases, the rate of disability among elderly individuals is also rising. Elderly patients undergoing home-based rehabilitation after surgery without medical supervision may experience complications and adverse events such as nausea, vomiting, or bleeding, which can impair recovery of daily living functions and commonly lead to readmission after discharge-particularly in older adults with multiple comorbidities, declining physical function, or cognitive impairment, who face a higher risk. Postoperative neurocognitive disorder (PND) is common following anesthesia and surgery, affecting up to 65% of adults aged 65 and older, and is associated with significant morbidity and mortality. Most patients do not undergo baseline or follow-up neuropsychological testing during the perioperative period or afterward, limiting the identification and early intervention for PND. With increasing life expectancy and a growing number of elderly patients undergoing surgery, the incidence of PND is expected to continue rising, primarily manifesting as declines in memory, attention, information processing, and cognitive flexibility. Current clinical studies suggest that advanced age, low educational level, pre-existing cognitive impairment, and alcohol and/or substance abuse are strong risk factors for developing PND. The perioperative period represents a critical window for identifying and assessing PND.
- Conditions
- PND, POCD - Postoperative Cognitive Dysfunction
- Being tested
- Ciprofol, propofol
- Medical subject headings
- Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiprofolDrug
Continuous infusion of ciprofol during general anesthesia
propofolDrug
Continuous infusion of propofol during general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Effects of Ciprofol on Perioperative Neurocognitive Function in Elderly Patients Undergoing Daytime | Experimental | Continuous infusion of ciprofol during general anesthesia Receives: Drug: Ciprofol |
| Effects of Propofol on Perioperative Neurocognitive Function in Elderly Patients Undergoing Daytime | Experimental | Not described Receives: Drug: propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence rate of PND
The primary outcome was the incidence of PND within 24 hours after surgery.
Measured: At least 1 day before the operation, 4 hours after the operation, and 24 hours after the operation.
Secondary outcomes (8)
The DST score
The changes in DST scores before and after the surgery
Measured: At least 1 day before the operation, 4 hours after the operation, and 24 hours after the operation.
The MMSE score
The changes in MMSE scores before and after the surgery
Measured: At least 1 day before the operation, 4 hours after the operation, and 24 hours after the operation.
anesthetic dosage
Measured: during operation
The TMT-A/B score
Measured: At least 1 day before the operation, 4 hours after the operation, and 24 hours after the operation.
The BNT score
Measured: At least 1 day before the operation, 4 hours after the operation, and 24 hours after the operation.
The AVLT-H score
Measured: At least 1 day before the operation, 4 hours after the operation, and 24 hours after the operation.
the clock drawing test score
Measured: At least 1 day before the operation, 4 hours after the operation, and 24 hours after the operation.
The QoR-15 score
Measured: At least 1 day before the operation, 4 hours after the operation, and 24 hours after the operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start25 Apr 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PNDStudies 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 4
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 148 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07895407
- Sponsor's protocol ID
- SAHoWMU-CR2026-03-104
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ciprofol on Perioperative Neurocognitive Function in Elderly Patients Undergoing Daytime Surgery
- ClinicalTrials.gov ID
- NCT07895407
- Acronym / sponsor ID
- SAHoWMU-CR2026-03-104
- Conditions
- PND, POCD - Postoperative Cognitive Dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Collaborators
- Affiliated Wenling Hospital of Wenzhou Medical University
- Study start
- 25 Apr 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 26 Oct 2026 (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.
As life expectancy increases, the rate of disability among elderly individuals is also rising. Elderly patients undergoing home-based rehabilitation after surgery without medical supervision may experience complications and adverse events such as nausea, vomiting, or bleeding, which can impair recovery of daily living functions and commonly lead to readmission after discharge-particularly in older adults with multiple comorbidities, declining physical function, or cognitive impairment, who face a higher risk. Postoperative neurocognitive disorder (PND) is common following anesthesia and surgery, affecting up to 65% of adults aged 65 and older, and is associated with significant morbidity and mortality. Most patients do not undergo baseline or follow-up neuropsychological testing during the perioperative period or afterward, limiting the identification and early intervention for PND. With increasing life expectancy and a growing number of elderly patients undergoing surgery, the incidence of PND is expected to continue rising, primarily manifesting as declines in memory, attention, information processing, and cognitive flexibility. Current clinical studies suggest that advanced age, low educational level, pre-existing cognitive impairment, and alcohol and/or substance abuse are strong risk factors for developing PND. The perioperative period represents a critical window for identifying and assessing PND.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Effects of Ciprofol on Perioperative Neurocognitive Function in Elderly Patients Undergoing Daytime | Experimental | Drug: CiprofolContinuous infusion of ciprofol during general anesthesia |
| Effects of Propofol on Perioperative Neurocognitive Function in Elderly Patients Undergoing Daytime | Experimental | Drug: propofol |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Age ≥ 65 years
- ASA I-II grade or ASA III grade, with stable coexisting diseases for more than 3 months, and after strict assessment and preparation for optimization.
Key exclusion criteria (8 listed)
- Acute central nervous system injury
- Diseases with drug contraindications or severe lesions in important organs such as the heart, brain, lungs, etc.
- Severe liver or kidney dysfunction
- History of schizophrenia, epilepsy, Parkinson's disease, myasthenia gravis or other mental disorders in the past
- History of alcoholism and/or drug abuse
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 |
|---|---|---|
| CiprofolContinuous infusion of ciprofol during general anesthesia | Drug | Effects of Ciprofol on Perioperative Neurocognitive Function in Elderly Patients Undergoing Daytime |
| propofolContinuous infusion of propofol during general anesthesia | Drug | Effects of Propofol on Perioperative Neurocognitive Function in Elderly Patients Undergoing Daytime |
Primary outcome
The incidence rate of PND
Time frame: At least 1 day before the operation, 4 hours after the operation, and 24 hours after the operation.
The primary outcome was the incidence of PND within 24 hours after surgery.
8 secondary outcomes
The DST score
Time frame: At least 1 day before the operation, 4 hours after the operation, and 24 hours after the operation.
The MMSE score
Time frame: At least 1 day before the operation, 4 hours after the operation, and 24 hours after the operation.
anesthetic dosage
Time frame: during operation
The TMT-A/B score
Time frame: At least 1 day before the operation, 4 hours after the operation, and 24 hours after the operation.
The BNT score
Time frame: At least 1 day before the operation, 4 hours after the operation, and 24 hours after the operation.
The AVLT-H score
Time frame: At least 1 day before the operation, 4 hours after the operation, and 24 hours after the operation.
the clock drawing test score
Time frame: At least 1 day before the operation, 4 hours after the operation, and 24 hours after the operation.
The QoR-15 score
Time frame: At least 1 day before the operation, 4 hours after the operation, and 24 hours after the operation.
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 26 Oct 2026.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ciprofol and propofol in people with PND and POCD - Postoperative Cognitive Dysfunction, 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 2 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: enrolling by invitation, as of the sponsor's last update on 26 Oct 2026. 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. 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?
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?
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?
The incidence rate of PND (time frame: At least 1 day before the operation, 4 hours after the operation, and 24 hours after the 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 26 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.