Ciprofol, Intraoperative Hypotension, Renin-angiotensin System Inhibitors
Conditions
Brief summary
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.
Interventions
DRUGCiprofol group
General anesthesia induction and maintenance were performed using ciprofol.
DRUGPropofol group
General anesthesia induction and maintenance were performed using propofol.
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients undergoing elective abdominal surgery under general anesthesia 2. Duration of surgery exceeding 2 hours 3. Patients receiving long-term renin-angiotensin system inhibitor therapy (\>3 months prior to surgery) 4. Age ≥ 65 years 5. ASA classification II-III 6. Informed consent was obtained from patients or their guardians
Exclusion criteria
1. History of allergy to opioids, propofol, or ciprofol components. 2. 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. 3. Severe hepatic dysfunction (total bilirubin ≥3.0 mg/dL or AST/ALT ≥2 times the upper limit of normal). 4. Severe renal impairment (creatinine clearance ≤30 mL/min). 5. 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). 6. Preoperative cognitive impairment, cerebrovascular disease, or history of psychiatric illness. 7. Abnormal thyroid-stimulating hormone levels or history of thyroid replacement therapy. 8. Unstable asthma or history of asthma. 9. Alcohol abuse, drug abuse, chronic opioid dependence, or analgesic use exceeding 3 months. 10. Lactating or pregnant women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The time-weighted average of hypotension | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time-weighted average of hypotension | within 15 minutes after induction of anesthesia | The time-weighted average is measured by calculating the area under the threshold (AUT) divided by the total duration of induction. |
| Incidence of intraoperative hypotension | From the beginning to the end of the surgery | — |
| Dosage of vasoactive drugs | From the beginning to the end of the surgery | — |
| Success rate of general anesthesia induction | From the beginning to the end of the surgery | 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 |
| Proportion of intraoperative time with BIS ≤ 60 | From the beginning to the end of the surgery | — |
| Total dosage of ciprofol and propofol | From the beginning to the end of the surgery | — |
| Total dosage of rescue drugs | From start of drug administration to MOAA/S ≤1 (up to 5 minutes) | — |
| Time to extubation | Perioperative | — |
| Changes in Cerebral Oxygen Saturation (rSO₂) | Intraoperative | — |
| Postoperative complications | From enrollment to the end of treatment at 3 months | delirium, myocardial injury, stroke, acute kidney injury, infection, sepsis, etc. |
| Incidence of intraoperative adverse events | From the beginning to the end of the surgery | — |
| Incidence of adverse events in the PACU | during the PACU stay | — |
| Incidence of perioperative major adverse cardiovascular and cerebrovascular events | Periprocedural | — |
| Changes in Stroke Volume Variation (SVV) | Intraoperative | Nomal value:≤10%,and higher scores mean a worse outcome. |
| Changes in Cardiac Index (CI) | Intraoperative | Nomal value:2.5-4.0 L/min/m²,and values outside the normal range suggest worse clinical outcomes |
| Changes in Systemic Vascular Resistance Index (SVRI) | Intraoperative | Nomal value :1970-2390 dyn·s·cm-⁵·m²,and values outside the normal range suggest worse clinical outcomes |
Other
| Measure | Time frame | Description |
|---|---|---|
| Quality of Recovery-15 (QoR-15) score | 3 day after surgery | — |
| emergency delirium | Periprocedural | RASS&CAM-ICU, delirium was judged according to whether there were positive features in the questionnaire |
Countries
China
Contacts
Primary ContactMin Yan
Outcome results
None listed