Cipepofol Anesthesia in TAVR
Trial question
What is the effect of cipepofol on hemodynamic impact in patients with severe aortic stenosis?
Study design
Single center
Single blinded
RCT
Population
Characteristics of study participants
43.0% female
57.0% male
N = 122
122 patients (53 female, 69 male).
Inclusion criteria: patients with aortic stenosis scheduled for TAVR.
Key exclusion criteria: preoperative tracheal intubation; known allergy to eggs, soy products, opioids or their reversal agents, or propofol; shock or hypotension unresponsive to vasopressors; neurological or psychiatric disorders; hemoglobin < 10 g/dL; long-term use of analgesics or sedatives.
Interventions
N=61 cipepofol (at a dose of 0.2 mg/kg for anesthesia induction).
N=61 propofol (at a dose of 1.0 mg/kg for anesthesia induction).
Primary outcome
Area under curve of the mean arterial pressure difference during the initial 15 minutes postinduction
8505 mmHg/s
13189 mmHg/s
13189.0 mmHg/s
9891.8 mmHg/s
6594.5 mmHg/s
3297.3 mmHg/s
0.0 mmHg/s
Cipepofol
Propofol
Significant
decrease ▼
Significant decrease in AUC of the mean arterial pressure difference during the initial 15 minutes postinduction (8505 mmHg/s vs. 13189 mmHg/s; AD -4684 mmHg/s, 95% CI -7463.28 to -1904.72).
Secondary outcomes
Significant decrease in postinduction hypotension (70.5% vs. 88.5%; ARD -18, 95% CI -31.7 to -4.3).
Significant increase in mean lowest mean arterial pressure (66 mmHg vs. 62 mmHg; AD 4 mmHg, 95% CI 1.09 to 6.91).
Significant decrease in norepinephrine dose during the entire procedure (356 mcg vs. 443 mcg; AD -87 mcg, 95% CI -170.17 to -3.83).
Safety outcomes
No significant differences in postoperative bradycardia, nausea, asthenia, hypertension, tachycardia, dizziness.
Significant differences in adverse events (73.8% vs. 88.5%), intraoperative hypotension (73.8% vs. 88.5%), injection site pain (9.8% vs. 55.7%).
Conclusion
In patients with aortic stenosis scheduled for TAVR, cipepofol was superior to propofol with respect to AUC of the mean arterial pressure difference during the initial 15 minutes postinduction.
Reference
Tingting Ni, Xiaoxia Zhou, Shuguang Wu et al. Hemodynamic Impact of Cipepofol vs Propofol During Anesthesia Induction in Patients With Severe Aortic Stenosis: A Randomized Clinical Trial. JAMA Surg. 2025 May 21:e251299. Online ahead of print.
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