Effect of Ciprofol on Intraoperative Hypotension in Elderly Patients Receiving Renin-angiotensin System Inhibitors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ciprofol group, Propofol group.
- Who it may be relevant to
- Registry conditions: Intraoperative Hypotension, Ciprofol, Renin-angiotensin System Inhibitors. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Ciprofol on Intraoperative Hypotension in Elderly Patients Receiving Renin-angiotensin System Inhibitors: a Prospective, Randomized Controlled Trial
Overview
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
- Drug Ciprofol group
General anesthesia induction and maintenance were performed using ciprofol. - Drug Propofol group
General anesthesia induction and maintenance were performed using propofol.
Primary outcome measures
- The time-weighted average of hypotension [Time frame: From the beginning to the end of the surgery]
Secondary outcome measures (12)
- 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]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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).
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
China · 1 center
- The Second Affiliated Hospital of Zhejiang University anesthesiology department — Hangzhou
Identifiers
NCT: NCT06952608 · 2025-0279