Safety and efficacy analysis of ciprofol combined with low-dose alfentanil in sedation of patients during transesophageal echocardiography: a randomized double-blind controlled study.

Abstract

Objective: To evaluate the anesthetic effects and safety of ciprofol combined with low-dose alfentanil in sedation of patients during Transesophageal Echocardiography (TEE).

Subjects and methods: This is a single-center, prospective, randomized, double-blind controlled clinical trial of 121 patients, aged 18-90 years, classified as ASA II-IV with a body mass index (BMI) ranging from 18-30 kg/m² scheduled for elective outpatient transesophageal echocardiography. These patients were randomly divided into two groups: the ciprofol group and the propofol group. Each patient received a bolus injection of alfentanyl 5 ug/kg intravenously, followed by either 0.5 mg/kg ciprofol or 2 mg/kg propofol over 30 s. The Transesophageal Echocardiography procedure began when the patient's Modified Observer's Assessment of Alertness/Sedation Scale (MOAA/S) score was ≤1. Intraoperative data such as the lowest blood pressure, lowest oxygen saturation, lowest respiratory rate, occurrence of new arrhythmias, need for assisted ventilation, use of vasopressors and their doses, patient movement, venous injection pain, and cough reflex were recorded. Prior to the recruitment of participants, the study was registered on a clinical research registration website under the title "Application of Intravenous Cipofol Combined with Low-Dose Alfentanil in Painless Transesophageal Echocardiography in Outpatient Settings," with the registration number ChiCTR2400081723.

Results: The incidence of respiratory and circulatory adverse events was significantly lower in the ciprofol group than in the propofol group (30.4% vs. 66.7%, p < 0.001). The incidence of adverse respiratory events in the ciprofol group was significantly lower than that in the propofol group (p < 0.001). The incidence rates of respiratory adverse events in the two groups were 18 (32.1%) and 45 (68.2%), respectively, indicating a statistically significant difference (p < 0.001). The incidence rates of circulatory adverse events were 15 (26.8%) and 33 (50.0%) in the ciprofol and propofol groups, respectively, with a statistically significant difference (p = 0.015). The rate of vasopressor use (p = 0.035) and occurrence of systolic blood pressure <90 mmHg (p < 0.001) were significantly lower in the ciprofol group than in the propofol group. There was no statistically significant difference in the incidence of heart rates less than 40 beats per minute or new-onset arrhythmias between the two groups. Additionally, the incidence of venous injection pain was significantly lower in the ciprofol group than in the propofol group [3 (5.4%) vs. 25 (37.9%), p < 0.001].

Conclusion: Ciprofol combined with low-dose alfentanil demonstrated a more favorable safety profile compared to Cpropofol, with significantly reduced rates of adverse events and injection pain.

Registration number: ChiCTR2400081723.