Postoperative Cognitive DysfunctionPhase 4NCT07673978
Effect of Ciprofol Injection on Postoperative Cognitive Function
A Phase 4 study testing Ciprofol group and Propofol group in people with Postoperative Cognitive Dysfunction, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial summary
This study aims to explore the effect of ciprofol on the postoperative cognitive function of inpatients undergoing gastrointestinal endoscopy examination, to compare the anesthetic effects and differences in adverse reactions of propofol and ciprofol in gastrointestinal endoscopy , to compare the incidence of… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Cognitive Dysfunction
- What is being tested?
- Ciprofol group and Propofol group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 298 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 30 Dec 2026
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 18-65 years old, ASA grade I-Ⅲ, BMI index: 18.5-30 kg/m ²
- Patients who plan to undergo gastroscopy or colonoscopy in our hospital
- The preoperative assessment of the MOCA scale in patients scheduled for elective surgery indicated normal cognitive function
- dextromanuality
- Voluntarily participate in this study and sign the informed consent form
Who cannot join
- Pregnant or lactating women
- Patients who have had cardiovascular and cerebrovascular accidents in the past
- Patients with severe diseases of the cardiovascular system, respiratory system and liver and kidney system
- Patients with obstructive sleep apnea syndrome
- Patients with concurrent neurological or mental system diseases, or those with incomplete intellectual development
- Patients allergic to ciprofol or propofol drugs
Show all 9Show fewer
- Patients with braking, visual/auditory impairments
- Patients with psychotropic drug addiction or alcohol dependence
- Patients who themselves or their attending physicians refused to participate in the study
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital Of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
About this study
Official title: A Controlled Study on the Impact of Ciprofol Injection on Postoperative Cognitive Function and Its Mechanism
This study aims to explore the effect of ciprofol on the postoperative cognitive function of inpatients undergoing gastrointestinal endoscopy examination, to compare the anesthetic effects and differences in adverse reactions of propofol and ciprofol in gastrointestinal endoscopy , to compare the incidence of postoperative cognitive decline in patients undergoing gastrointestinal endoscopy examination between propofol and coprofol, and to optimize the anesthesia medication regimen for patients undergoing gastrointestinal endoscopy examination.
- Conditions
- Postoperative Cognitive Dysfunction
- Being tested
- Ciprofol group, Propofol group
- 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.
Ciprofol groupDrug
patients in the Ciprofol group will use ciprofol to complete the painless gastroscopy and colonoscopy treatment.
Propofol groupDrug
patients in the propofol group will use propofol to complete the painless gastroscopy and colonoscopy treatment.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group (ciprofol) | Experimental | patients in the Ciprofol group will use ciprofol to complete the painless gastroscopy and colonoscopy treatment. Receives: Drug: Ciprofol group |
| Control group (propofol) | Active comparator | patients in the propofol group will use propofol to complete the painless gastroscopy and colonoscopy treatment. Receives: Drug: Propofol group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in the incidence of cognitive function decline between ciprofol and propofol in patients undergoing painless gastroscopy and colonoscopy treatment
Measured: From the time the patient was enrolled in the study to 24 hours after the treatment
Secondary outcomes (5)
Intraoperative and postoperative adverse events
Measured: From the time the patient enters the operating room to 24 hours after the treatment
Blood Pressure (mmHg)
Non-invasive BP measured by cuff after entry and intermittently during surgery. Hypotension: SBP decrease >30% from baseline; Hypertension: SBP increase >30% from baseline.
Measured: From entering the operating room to leaving it (before anesthesia, after induction, and 5 minutes、10 minutes 、20 minutes 、30 minutes 、40 minutes、50 minutes、60 minutes after the operation began)
Heart Rate (beats/min)
Read from monitor. Bradycardia: <50 bpm or decrease ≥25% from baseline; Tachycardia: >100 bpm or increase ≥25% from baseline.
Measured: From entering the operating room to leaving it (before anesthesia, after induction, and 5 minutes、10 minutes 、20 minutes 、30 minutes 、40 minutes、50 minutes、60 minutes after the operation began)
Respiratory Rate (breaths/min)
Read from monitor or counted over 1 min. Respiratory depression: <8 breaths/min lasting >30 sec.
Measured: From entering the operating room to leaving it (before anesthesia, after induction, and 5 minutes、10 minutes 、20 minutes 、30 minutes 、40 minutes、50 minutes、60 minutes after the operation began)
Oxygen Saturation (Pulse Oximetry)
Read from monitor. Hypoxemia: SpO2 <90% lasting >15 sec.
Measured: From entering the operating room to leaving it (before anesthesia, after induction, and 5 minutes、10 minutes 、20 minutes 、30 minutes 、40 minutes、50 minutes、60 minutes after the operation began)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start1 Jun 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Cognitive DysfunctionStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 298 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guangyou Duan, The Second Affiliated Hospital of Chongqing Medical University
- Investigators
- Guangyou Duan, Study director, The Second Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07673978
- Sponsor's protocol ID
- 2026-166
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 29 Jun 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 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Study on the Impact of Ciprofol Injection on Postoperative Cognitive Function and Its Mechanism
- ClinicalTrials.gov ID
- NCT07673978
- Acronym / sponsor ID
- 2026-166
- Conditions
- Postoperative Cognitive Dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 298 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 29 Jun 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 study aims to explore the effect of ciprofol on the postoperative cognitive function of inpatients undergoing gastrointestinal endoscopy examination, to compare the anesthetic effects and differences in adverse reactions of propofol and ciprofol in gastrointestinal endoscopy , to compare the incidence of postoperative cognitive decline in patients undergoing gastrointestinal endoscopy examination between propofol and coprofol, and to optimize the anesthesia medication regimen for patients undergoing gastrointestinal endoscopy examination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group (ciprofol) | Experimental | Drug: Ciprofol grouppatients in the Ciprofol group will use ciprofol to complete the painless gastroscopy and colonoscopy treatment. |
| Control group (propofol) | Active comparator | Drug: Propofol grouppatients in the propofol group will use propofol to complete the painless gastroscopy and colonoscopy treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 18-65 years old, ASA grade I-Ⅲ, BMI index: 18.5-30 kg/m ²
- Patients who plan to undergo gastroscopy or colonoscopy in our hospital
- The preoperative assessment of the MOCA scale in patients scheduled for elective surgery indicated normal cognitive function
- dextromanuality
- Voluntarily participate in this study and sign the informed consent form
Key exclusion criteria (9 listed)
- Pregnant or lactating women
- Patients who have had cardiovascular and cerebrovascular accidents in the past
- Patients with severe diseases of the cardiovascular system, respiratory system and liver and kidney system
- Patients with obstructive sleep apnea syndrome
- Patients with concurrent neurological or mental system diseases, or those with incomplete intellectual development
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 |
|---|---|---|
| Ciprofol grouppatients in the Ciprofol group will use ciprofol to complete the painless gastroscopy and colonoscopy treatment. | Drug | Experimental group (ciprofol) |
| Propofol grouppatients in the propofol group will use propofol to complete the painless gastroscopy and colonoscopy treatment. | Drug | Control group (propofol) |
Primary outcome
The difference in the incidence of cognitive function decline between ciprofol and propofol in patients undergoing painless gastroscopy and colonoscopy treatment
Time frame: From the time the patient was enrolled in the study to 24 hours after the treatment
5 secondary outcomes
Intraoperative and postoperative adverse events
Time frame: From the time the patient enters the operating room to 24 hours after the treatment
Blood Pressure (mmHg)
Time frame: From entering the operating room to leaving it (before anesthesia, after induction, and 5 minutes、10 minutes 、20 minutes 、30 minutes 、40 minutes、50 minutes、60 minutes after the operation began)
Heart Rate (beats/min)
Time frame: From entering the operating room to leaving it (before anesthesia, after induction, and 5 minutes、10 minutes 、20 minutes 、30 minutes 、40 minutes、50 minutes、60 minutes after the operation began)
Respiratory Rate (breaths/min)
Time frame: From entering the operating room to leaving it (before anesthesia, after induction, and 5 minutes、10 minutes 、20 minutes 、30 minutes 、40 minutes、50 minutes、60 minutes after the operation began)
Oxygen Saturation (Pulse Oximetry)
Time frame: From entering the operating room to leaving it (before anesthesia, after induction, and 5 minutes、10 minutes 、20 minutes 、30 minutes 、40 minutes、50 minutes、60 minutes after the operation began)
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 29 Jun 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.
Guangyou Duan study director
The Second Affiliated Hospital of Chongqing Medical University
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 group and Propofol group in people with Postoperative Cognitive Dysfunction, run by The Second Affiliated Hospital of Chongqing 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 9 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: under way, not looking for participants, as of the sponsor's last update on 29 Jun 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 difference in the incidence of cognitive function decline between ciprofol and propofol in patients undergoing painless gastroscopy and colonoscopy treatment (time frame: From the time the patient was enrolled in the study to 24 hours after the treatment). 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 29 Jun 2026.