Status:
RECRUITING
Effect of Ciprofol on Intraoperative Hypotension in Elderly Patients Receiving Renin-angiotensin System Inhibitors
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Intraoperative Hypotension
Ciprofol
Eligibility:
All Genders
65+ years
Phase:
PHASE4
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 m...
Detailed Description
Elderly patients receiving long-term renin-angiotensin system inhibitors commonly exhibit reduced vascular elasticity, impaired cardiovascular reserve, and diminished compensatory mechanisms. Regular ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 10 2026
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT06952608
Start Date
April 10 2025
End Date
April 10 2026
Last Update
December 30 2025
Active Locations (1)
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1
The Second Affiliated Hospital of Zhejiang University anesthesiology department
Hangzhou, Zhejiang, China, 310000