Neurocognitive FunctionNCT07887594
Comparison of the Effects of Ciprofol and Propofol on Cognitive Function After Painless Gastroenteroscopy
An observational study of Neurocognitive Function, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
This randomized platform trial compared ciprofol and propofol for early neurocognitive recovery in adults undergoing painless gastrointestinal endoscopy. The primary outcome was the incidence of delayed neurocognitive recovery (dNCR) at PACU discharge, assessed via MoCA, DST, SMDT, STT, and Stroop tests (≥ 1 SD… Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurocognitive Function
- What is being tested?
- Ciprofol
- Type of treatment
- Injection or infusion
- How many people
- 196 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 6 Oct 2026
- How long will I take part?
- 7 Days
- Phase
- Observational
- 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 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Adult outpatients aged ≥ 18 years who were scheduled for elective painless gastrointestinal endoscopy and met the predefined inclusion and exclusion criteria were enrolled. Key inclusion requirements were ASA physical status I-III with stable comorbidities and provision of signed informed consent. Patients with psychiatric disorders, cognitive impairment, substance or alcohol abuse, BMI > 30 kg/m², severe organ dysfunction, or known hypersensitivity to ciprofol, propofol, or opioids were excluded.
Who may be able to join
- ASA physical status I, II, or III (concurrent diseases stable for ≥ 3 months with documented optimization)
- Scheduled for elective painless gastrointestinal endoscopy under sedation
- Provision of signed informed consent by the patient or legally authorized representative
Who cannot join
- Known psychiatric disorders, cognitive impairment, or inability to cooperate with preoperative evaluation
- Confirmed or suspected history of abuse or dependence on narcotic, sedative, or analgesic drugs
- Long-term alcohol abuse
- Body mass index (BMI) > 30 kg/m²
- Severe cardiac, pulmonary, hepatic, or renal disease
- Known hypersensitivity to ciprofol, propofol, opioids, or related agents
Trial locations and contacts
1 site in 1 country.
China1 site
Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
About this study
This randomized platform trial compared ciprofol and propofol for early neurocognitive recovery in adults undergoing painless gastrointestinal endoscopy. The primary outcome was the incidence of delayed neurocognitive recovery (dNCR) at PACU discharge, assessed via MoCA, DST, SMDT, STT, and Stroop tests (≥ 1 SD decline from baseline in ≥ 2 domains). Secondary outcomes included PACU stay duration, total drug dosage, and adverse events (hypoxemia, hypotension, bradycardia, body movement). Assessments were performed at baseline and before PACU discharge (Modified Aldrete ≥ 9).
- Conditions
- Neurocognitive Function
- Being tested
- Ciprofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiprofolDrug
Give Ciprofol Injection 0.4mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Propofol group | Give Propofol Injection 2mg/kg Receives: Drug: Ciprofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of delayed neurocognitive recovery (dNCR) at PACU discharge
Assessed at baseline (pre-procedure) and before PACU discharge (Modified Aldrete score ≥9). Tests: MoCA, DST, SMDT, STT, and Stroop test. dNCR defined as ≥1 SD decline from baseline in ≥2 cognitive domains.
Measured: Baseline (pre-procedure) and before PACU discharge (Modified Aldrete score ≥9)
Secondary outcomes (2)
PACU stay duration
time from PACU admission to discharge (Modified Aldrete score ≥9).
Measured: Intraoperatively to PACU discharge
total anesthetic dosage
cumulative ciprofol or propofol used intraoperatively (mg and mg/kg).
Measured: Intraoperatively to PACU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start1 Jul 2025
- Primary completion6 Oct 2026
- Study completion6 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurocognitive FunctionStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 196 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Affiliated Wenling Hospital of Wenzhou Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07887594
- Sponsor's protocol ID
- SAHoWMU-CR2026-03-105
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Ciprofol and Propofol on Cognitive Function After Painless Gastroenteroscopy
- ClinicalTrials.gov ID
- NCT07887594
- Acronym / sponsor ID
- SAHoWMU-CR2026-03-105
- Conditions
- Neurocognitive Function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Collaborators
- Affiliated Wenling Hospital of Wenzhou Medical University
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 6 Oct 2026 (actual)
- Study completion
- 6 Oct 2026 (actual)
- First posted
- 21 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.
This randomized platform trial compared ciprofol and propofol for early neurocognitive recovery in adults undergoing painless gastrointestinal endoscopy. The primary outcome was the incidence of delayed neurocognitive recovery (dNCR) at PACU discharge, assessed via MoCA, DST, SMDT, STT, and Stroop tests (≥ 1 SD decline from baseline in ≥ 2 domains). Secondary outcomes included PACU stay duration, total drug dosage, and adverse events (hypoxemia, hypotension, bradycardia, body movement). Assessments were performed at baseline and before PACU discharge (Modified Aldrete ≥ 9).
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 7 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Propofol group | – | Drug: CiprofolGive Propofol Injection 2mg/kg |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Adult outpatients aged ≥ 18 years who were scheduled for elective painless gastrointestinal endoscopy and met the predefined inclusion and exclusion criteria were enrolled. Key inclusion requirements were ASA physical status I-III with stable comorbidities and provision of signed informed consent. Patients with psychiatric disorders, cognitive impairment, substance or alcohol abuse, BMI > 30 kg/m², severe organ dysfunction, or known hypersensitivity to ciprofol, propofol, or opioids were excluded.
Key inclusion criteria (3 listed)
- ASA physical status I, II, or III (concurrent diseases stable for ≥ 3 months with documented optimization)
- Scheduled for elective painless gastrointestinal endoscopy under sedation
- Provision of signed informed consent by the patient or legally authorized representative
Key exclusion criteria (6 listed)
- Known psychiatric disorders, cognitive impairment, or inability to cooperate with preoperative evaluation
- Confirmed or suspected history of abuse or dependence on narcotic, sedative, or analgesic drugs
- Long-term alcohol abuse
- Body mass index (BMI) > 30 kg/m²
- Severe cardiac, pulmonary, hepatic, or renal disease
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 |
|---|---|---|
| CiprofolGive Ciprofol Injection 0.4mg/kg | Drug | Propofol group |
Primary outcome
Incidence of delayed neurocognitive recovery (dNCR) at PACU discharge
Time frame: Baseline (pre-procedure) and before PACU discharge (Modified Aldrete score ≥9)
Assessed at baseline (pre-procedure) and before PACU discharge (Modified Aldrete score ≥9). Tests: MoCA, DST, SMDT, STT, and Stroop test. dNCR defined as ≥1 SD decline from baseline in ≥2 cognitive domains.
2 secondary outcomes
PACU stay duration
Time frame: Intraoperatively to PACU discharge
total anesthetic dosage
Time frame: Intraoperatively to PACU discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: Yes
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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.
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?
An observational study of Neurocognitive Function, 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 21 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 delayed neurocognitive recovery (dNCR) at PACU discharge (time frame: Baseline (pre-procedure) and before PACU discharge (Modified Aldrete score ≥9)). 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 21 Oct 2026.