NCT06952608 Effect of Ciprofol on Intraoperative Hypotension in Elderly Patients Receiving Renin-angiotensin System Inhibitors
| NCT ID | NCT06952608 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Condition | Intraoperative Hypotension |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2025-04-10 |
| Primary Completion | 2026-02-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 140 participants in total. It began in 2025-04-10 with a primary completion date of 2026-02-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Min Yan
STUDY DIRECTOR
Second Affiliated Hospital, School of Medicine, Zhejiang University
Frequently Asked Questions
Who can join the NCT06952608 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Intraoperative Hypotension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06952608 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06952608 currently recruiting?
Yes, NCT06952608 is actively recruiting participants. Contact the research team at zryanmin@zju.edu.cn for enrollment information.
Where is the NCT06952608 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT06952608 clinical trial?
NCT06952608 is sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. The principal investigator is Min Yan at Second Affiliated Hospital, School of Medicine, Zhejiang University. The trial plans to enroll 140 participants.