Intraoperative HypotensionPhase 4NCT06952608
Effect of Ciprofol on Intraoperative Hypotension in Elderly Patients Receiving Renin-angiotensin System Inhibitors
A Phase 4 study testing Ciprofol group and Propofol group in people with Intraoperative Hypotension and Ciprofol, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The prevention of intraoperative hypotension could reduce postoperative organ injury and mortality, particularly in elderly patients receiving long-term renin-angiotensin system inhibitors. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Intraoperative Hypotension, Ciprofol, Renin-angiotensin System Inhibitors
- What is being tested?
- Ciprofol group and Propofol group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2025to 10 Apr 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients undergoing elective abdominal surgery under general anesthesia
- Duration of surgery exceeding 2 hours
- Patients receiving long-term renin-angiotensin system inhibitor therapy (>3 months prior to surgery)
- Age ≥ 65 years
- ASA classification II-III
- Informed consent was obtained from patients or their guardians
Who cannot join
- History of allergy to opioids, propofol, or ciprofol components.
- Anticipated difficult airway (limited mouth opening, restricted neck movement, or modified Mallampati grade III-IV) or difficult mask ventilation.
- Body mass index ≤18 or ≥35 kg/m².
- Severe hepatic dysfunction (total bilirubin ≥3.0 mg/dL or AST/ALT ≥2 times the upper limit of normal).
- Severe renal impairment (creatinine clearance ≤30 mL/min).
- Cardiac diseases (AV block higher than first-degree, heart rate <50 bpm, severe arrhythmias, severe valvular heart disease, heart failure, or unstable angina on the day of surgery).
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- Preoperative cognitive impairment, cerebrovascular disease, or history of psychiatric illness.
- Abnormal thyroid-stimulating hormone levels or history of thyroid replacement therapy.
- Unstable asthma or history of asthma.
- Alcohol abuse, drug abuse, chronic opioid dependence, or analgesic use exceeding 3 months.
- Lactating or pregnant women.
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 Second Affiliated Hospital of Zhejiang University anesthesiology department
Hangzhou, Zhejiang, 310000
Min Yan, 15888210247, zryanmin@zju.edu.cn
Min Yan, Doctor
About this study
Official title: The Effect of Ciprofol on Intraoperative Hypotension in Elderly Patients Receiving Renin-angiotensin System Inhibitors: a Prospective, Randomized Controlled Trial
The prevention of intraoperative hypotension could reduce postoperative organ injury and mortality, particularly in elderly patients receiving long-term renin-angiotensin system inhibitors. Previous meta-analyses suggest that ciprofol, a novel intravenous anesthetic agent, may provide improved hemodynamic stability compared to propofol; however, its precise effects on perioperative hemodynamics remain unclear. The study will assess whether ciprofol improves perioperative hemodynamic stability in elderly patients receiving renin-angiotensin system inhibitors.
Read the detailed description
Elderly patients receiving long-term renin-angiotensin system inhibitors commonly exhibit reduced vascular elasticity, impaired cardiovascular reserve, and diminished compensatory mechanisms. Regular use of renin-angiotensin system inhibitors has thus emerged as a significant risk factor for intraoperative hypotension, increasing the potential for end-organ injury and closely correlating with postoperative complications such as myocardial injury, acute kidney injury, and increased mortality.
Ciprofol (HSK3486) is a novel intravenous anesthetic agent that has demonstrated efficacy non-inferior to propofol for induction and maintenance of general anesthesia, with an improved safety profile and fewer adverse effects. Recent meta-analyses indicate that ciprofol administration is associated with a significantly reduced incidence of intraoperative hypotension compared with propofol; however, robust evidence from randomized controlled trials (RCTs) remains limited. The present study aims to evaluate the impact of ciprofol on perioperative hemodynamics in elderly patients receiving renin-angiotensin system inhibitors. Given the increased risk of intraoperative hypotension in this patient cohort, the investigation of hemodynamic stability with ciprofol holds substantial clinical significance and may inform anesthetic management strategies for this vulnerable population.
- Being tested
- Ciprofol group, Propofol group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ciprofol groupDrug
General anesthesia induction and maintenance were performed using ciprofol.
Propofol groupDrug
General anesthesia induction and maintenance were performed using propofol.
| Study group | Role | What they receive |
|---|---|---|
| Ciprofol Group | Experimental | General anesthesia induction and maintenance were performed using ciprofol. Receives: Drug: Ciprofol group |
| Propofol group | Placebo comparator | General anesthesia induction and maintenance were performed using propofol. Receives: Drug: Propofol group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time-weighted average of hypotension
The time-weighted average is measured by calculating the area under the threshold (AUT) divided by the total duration of surgery
Measured: From the beginning to the end of the surgery
Secondary outcomes (16)
Time-weighted average of hypotension
The time-weighted average is measured by calculating the area under the threshold (AUT) divided by the total duration of induction.
Measured: within 15 minutes after induction of anesthesia
Incidence of intraoperative hypotension
Measured: From the beginning to the end of the surgery
Dosage of vasoactive drugs
Measured: From the beginning to the end of the surgery
Success rate of general anesthesia induction
MOAA/S score of 1 or less after administration of ciprofol or propofol, 1 or fewer top-up doses, and no use of rescue drug
Measured: From the beginning to the end of the surgery
Proportion of intraoperative time with BIS ≤ 60
Measured: From the beginning to the end of the surgery
Total dosage of ciprofol and propofol
Measured: From the beginning to the end of the surgery
Total dosage of rescue drugs
Measured: From start of drug administration to MOAA/S ≤1 (up to 5 minutes)
Time to extubation
Measured: Perioperative
Incidence of intraoperative adverse events
Measured: From the beginning to the end of the surgery
Incidence of adverse events in the PACU
Measured: during the PACU stay
Incidence of perioperative major adverse cardiovascular and cerebrovascular events
Measured: Periprocedural
Changes in Stroke Volume Variation (SVV)
Nomal value:≤10%,and higher scores mean a worse outcome.
Measured: Intraoperative
Changes in Cardiac Index (CI)
Nomal value:2.5-4.0 L/min/m²,and values outside the normal range suggest worse clinical outcomes
Measured: Intraoperative
Changes in Systemic Vascular Resistance Index (SVRI)
Nomal value :1970-2390 dyn·s·cm-⁵·m²,and values outside the normal range suggest worse clinical outcomes
Measured: Intraoperative
Changes in Cerebral Oxygen Saturation (rSO₂)
Measured: Intraoperative
Postoperative complications
delirium, myocardial injury, stroke, acute kidney injury, infection, sepsis, etc.
Measured: From enrollment to the end of treatment at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start10 Apr 2025
- Primary completion10 Feb 2026 (estimated)
- Study completion10 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative HypotensionStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Min Yan, Study director, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06952608
- Sponsor's protocol ID
- 2025-0279
- Status last verified
- Apr 2025
- First submitted
- 13 Apr 2025
- Last updated
- 30 Dec 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 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ciprofol on Intraoperative Hypotension in Elderly Patients Receiving Renin-angiotensin System Inhibitors: a Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06952608
- Acronym / sponsor ID
- 2025-0279
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- 10 Feb 2026 (estimated)
- Study completion
- 10 Apr 2026 (estimated)
- First posted
- 1 May 2025 (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.
The prevention of intraoperative hypotension could reduce postoperative organ injury and mortality, particularly in elderly patients receiving long-term renin-angiotensin system inhibitors. Previous meta-analyses suggest that ciprofol, a novel intravenous anesthetic agent, may provide improved hemodynamic stability compared to propofol; however, its precise effects on perioperative hemodynamics remain unclear. The study will assess whether ciprofol improves perioperative hemodynamic stability in elderly patients receiving renin-angiotensin system inhibitors.
Detailed description
Elderly patients receiving long-term renin-angiotensin system inhibitors commonly exhibit reduced vascular elasticity, impaired cardiovascular reserve, and diminished compensatory mechanisms. Regular use of renin-angiotensin system inhibitors has thus emerged as a significant risk factor for intraoperative hypotension, increasing the potential for end-organ injury and closely correlating with postoperative complications such as myocardial injury, acute kidney injury, and increased mortality.
Ciprofol (HSK3486) is a novel intravenous anesthetic agent that has demonstrated efficacy non-inferior to propofol for induction and maintenance of general anesthesia, with an improved safety profile and fewer adverse effects. Recent meta-analyses indicate that ciprofol administration is associated with a significantly reduced incidence of intraoperative hypotension compared with propofol; however, robust evidence from randomized controlled trials (RCTs) remains limited. The present study aims to evaluate the impact of ciprofol on perioperative hemodynamics in elderly patients receiving renin-angiotensin system inhibitors. Given the increased risk of intraoperative hypotension in this patient cohort, the investigation of hemodynamic stability with ciprofol holds substantial clinical significance and may inform anesthetic management strategies for this vulnerable population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ciprofol Group | Experimental | Drug: Ciprofol groupGeneral anesthesia induction and maintenance were performed using ciprofol. |
| Propofol group | Placebo comparator | Drug: Propofol groupGeneral anesthesia induction and maintenance were performed using propofol. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Patients undergoing elective abdominal surgery under general anesthesia
- Duration of surgery exceeding 2 hours
- Patients receiving long-term renin-angiotensin system inhibitor therapy (>3 months prior to surgery)
- Age ≥ 65 years
- ASA classification II-III
Key exclusion criteria (11 listed)
- History of allergy to opioids, propofol, or ciprofol components.
- Anticipated difficult airway (limited mouth opening, restricted neck movement, or modified Mallampati grade III-IV) or difficult mask ventilation.
- Body mass index ≤18 or ≥35 kg/m².
- Severe hepatic dysfunction (total bilirubin ≥3.0 mg/dL or AST/ALT ≥2 times the upper limit of normal).
- Severe renal impairment (creatinine clearance ≤30 mL/min).
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 groupGeneral anesthesia induction and maintenance were performed using ciprofol. | Drug | Ciprofol Group |
| Propofol groupGeneral anesthesia induction and maintenance were performed using propofol. | Drug | Propofol group |
Primary outcome
The time-weighted average of hypotension
Time frame: From the beginning to the end of the surgery
The time-weighted average is measured by calculating the area under the threshold (AUT) divided by the total duration of surgery
16 secondary outcomes
Time-weighted average of hypotension
Time frame: within 15 minutes after induction of anesthesia
Incidence of intraoperative hypotension
Time frame: From the beginning to the end of the surgery
Dosage of vasoactive drugs
Time frame: From the beginning to the end of the surgery
Success rate of general anesthesia induction
Time frame: From the beginning to the end of the surgery
Proportion of intraoperative time with BIS ≤ 60
Time frame: From the beginning to the end of the surgery
Total dosage of ciprofol and propofol
Time frame: From the beginning to the end of the surgery
Total dosage of rescue drugs
Time frame: From start of drug administration to MOAA/S ≤1 (up to 5 minutes)
Time to extubation
Time frame: Perioperative
Incidence of intraoperative adverse events
Time frame: From the beginning to the end of the surgery
Incidence of adverse events in the PACU
Time frame: during the PACU stay
Incidence of perioperative major adverse cardiovascular and cerebrovascular events
Time frame: Periprocedural
Changes in Stroke Volume Variation (SVV)
Time frame: Intraoperative
Changes in Cardiac Index (CI)
Time frame: Intraoperative
Changes in Systemic Vascular Resistance Index (SVRI)
Time frame: Intraoperative
Changes in Cerebral Oxygen Saturation (rSO₂)
Time frame: Intraoperative
Postoperative complications
Time frame: From enrollment to the end of treatment at 3 months
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 30 Dec 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.
Min Yan study director
Second Affiliated Hospital, Zhejiang University, School of Medicine
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 Intraoperative Hypotension and Ciprofol, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 6 inclusion and 11 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 30 Dec 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.
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?
Contact Min Yan (0571-87783759, zryanmin@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time-weighted average of hypotension (time frame: From the beginning to the end of the surgery). 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 30 Dec 2025.