Ciprofol's effect on low blood pressure during surgery in elderly patients on certain medications

The Effect of Ciprofol on Intraoperative Hypotension in Elderly Patients Receiving Renin-angiotensin System Inhibitors: a Prospective, Randomized Controlled Trial

This study is testing if a new anesthetic called ciprofol can help prevent low blood pressure during surgery in older patients who have been taking certain heart medications.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 65 Years and up
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Academic / other)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06952608 on ClinicalTrials.gov

What this trial studies

This study evaluates the impact of ciprofol, a new intravenous anesthetic, on preventing low blood pressure during surgery in elderly patients who have been taking renin-angiotensin system inhibitors for over three months. The research focuses on patients undergoing elective abdominal surgery lasting more than two hours, assessing whether ciprofol can provide better hemodynamic stability compared to the traditional anesthetic propofol. Given the increased risk of intraoperative hypotension in this demographic, the findings could significantly influence anesthetic practices for these vulnerable patients.

Who should consider this trial

Good fit: Ideal candidates are elderly patients aged 65 and older, undergoing elective abdominal surgery while on long-term renin-angiotensin system inhibitors.

Not a fit: Patients with severe cardiac, hepatic, or renal conditions, or those with a history of allergies to the study medications, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved safety and outcomes for elderly patients undergoing surgery by reducing the risk of intraoperative hypotension.

How similar studies have performed: Previous studies have suggested that ciprofol may reduce intraoperative hypotension compared to propofol, but robust evidence from randomized controlled trials is still limited.

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.

Where this trial is running

Hangzhou, Zhejiang

• The Second Affiliated Hospital of Zhejiang University anesthesiology department — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Min Yan

Conditions Intraoperative Hypotension; Ciprofol; Renin-angiotensin System Inhibitors