Clinical trial NCT06952608: Effect of Ciprofol on Intraoperative Hypotension in Elderly Patients Receiving Renin-angiotensin System Inhibitors
Official title: The Effect of Ciprofol on Intraoperative Hypotension in Elderly Patients Receiving Renin-angiotensin System Inhibitors: a Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Intraoperative Hypotension
Ciprofol
Renin-angiotensin System Inhibitors
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2025-05-01
Enrollment: 140
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The time-weighted average of hypotension
timeFrame: From the beginning to the end of the surgery
Secondary outcomes:
measure: Time-weighted average of hypotension
timeFrame: within 15 minutes after induction of anesthesia
measure: Incidence of intraoperative hypotension
timeFrame: From the beginning to the end of the surgery
measure: Dosage of vasoactive drugs
timeFrame: From the beginning to the end of the surgery
measure: Success rate of general anesthesia induction
timeFrame: From the beginning to the end of the surgery
measure: Proportion of intraoperative time with BIS ≤ 60
timeFrame: From the beginning to the end of the surgery
measure: Total dosage of ciprofol and propofol
timeFrame: From the beginning to the end of the surgery
measure: Total dosage of rescue drugs
timeFrame: From start of drug administration to MOAA/S ≤1 (up to 5 minutes)
measure: Time to extubation
timeFrame: Perioperative
measure: Incidence of intraoperative adverse events
timeFrame: From the beginning to the end of the surgery
measure: Incidence of adverse events in the PACU
timeFrame: during the PACU stay
measure: Incidence of perioperative major adverse cardiovascular and cerebrovascular events
timeFrame: Periprocedural
measure: Changes in Stroke Volume Variation (SVV)
timeFrame: Intraoperative
measure: Changes in Cardiac Index (CI)
timeFrame: Intraoperative
measure: Changes in Systemic Vascular Resistance Index (SVRI)
timeFrame: Intraoperative
measure: Changes in Cerebral Oxygen Saturation (rSO₂)
timeFrame: Intraoperative
Other outcomes:
measure: Quality of Recovery-15 (QoR-15) score
timeFrame: 3 day after surgery
measure: emergency delirium
timeFrame: Periprocedural
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University anesthesiology department
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Min Yan
role: STUDY_DIRECTOR
References: