Gastroenterology · Medical Literature
Ciprofol versus Propofol Combined with Alfentanil for Respiratory Adverse Events in Overweight Patients Undergoing Painless Gastroscopy: A Randomized Controlled Trial.
Abstract
Respiratory management remains a major challenge during painless endoscopy in overweight or obese patients because of altered body fat distribution and reduced pulmonary reserve. This study evaluated whether ciprofol could reduce respiratory adverse events compared with propofol during painless gastroscopy in this population. In this single-center, prospective, single-blind randomized controlled trial, 106 overweight or obese patients undergoing painless gastroscopy were randomly assigned (1:1) to receive either propofol (2 mg/kg) or ciprofol (0.4 mg/kg) following intravenous alfentanil (5 μg/kg). The primary outcome was the overall incidence of respiratory adverse events from anesthesia induction to completion of endoscopy, including hypoxemia (SpO2 15 s), respiratory depression (respiratory rate 30 s), and apnea (absence of chest wall movement for >20 s). A total of 106 patients completed the study (53 per group). The incidence of respiratory adverse events was significantly lower in the ciprofol group than in the propofol group (33.96% vs. 66.04%, P=0.001). The lowest intraoperative SpO2 was significantly higher in the ciprofol group (93.50% vs. 89.00%, P=0.044). Compared with ciprofol, propofol was associated with higher incidences of hypotension (22.64% vs. 7.55%, P=0.030) and injection pain (18.87% vs. 0%, P=0.001). No significant differences were observed in other adverse events, including nausea and vomiting. In overweight or obese patients undergoing painless gastroscopy, ciprofol at 0.4 mg/kg significantly reduced respiratory adverse events, improved oxygenation, and decreased injection pain compared with propofol. These findings suggest that ciprofol may be a preferable anesthetic option for painless endoscopy in this population. ChiCTR2600117367.
Clinical relevance
Overweight and obese patients undergoing procedural sedation for painless gastroscopy face heightened risk of respiratory adverse events due to altered body fat distribution, reduced functional residual capacity, and diminished pulmonary reserve — making sedation agent selection critically important. This RCT directly compares ciprofol, a newer GABA-A receptor agonist, against the standard-of-care propofol in this vulnerable population, addressing a clinically meaningful gap in evidence. As overweight and obesity prevalence continues to rise globally, optimizing sedation protocols for endoscopy to minimize respiratory compromise is an immediate and pressing clinical priority.
Key findings
1. The overall incidence of respiratory adverse events (composite of hypoxemia [SpO2 15 s], respiratory depression [RR 30 s], and apnea [absent chest wall movement for >20 s]) was significantly lower in the ciprofol group versus the propofol group (33.96% vs. 66.04%, P=0.001). 2. The lowest intraoperative SpO2 was significantly higher in the ciprofol group compared with the propofol group (93.50% vs. 89.00%, P=0.044), indicating superior intraoperative oxygenation maintenance. 3. Hypotension incidence was significantly lower with ciprofol than with propofol (7.55% vs. 22.64%, P=0.030), suggesting a more favorable hemodynamic profile. 4. Injection pain was significantly less frequent with ciprofol (0% vs. 18.87% with propofol, P=0.001), representing a clinically meaningful patient comfort advantage. 5. No statistically significant differences in other adverse events, including postoperative nausea and vomiting, were observed between the two groups. 6. The trial was a single-center, prospective, single-blind RCT with 106 patients completing the study (53 per group, 1:1 allocation), with all patients receiving alfentanil 5 µg/kg IV prior to the study agent (ciprofol 0.4 mg/kg vs. propofol 2 mg/kg).
Practice implications
For overweight or obese patients (BMI consistent with overweight/obesity criteria) scheduled for painless gastroscopy with alfentanil-based sedation, substituting ciprofol 0.4 mg/kg for propofol 2 mg/kg should be considered to significantly reduce the composite risk of respiratory adverse events, including hypoxemia and apnea, while also lowering the risk of procedural hypotension. Clinicians should note that ciprofol eliminated injection pain entirely in this cohort (0% vs. 18.87%), which may also improve patient satisfaction and procedural cooperation without additional analgesic requirements. While these findings support ciprofol as a preferable sedation agent in this specific population, generalizability is limited by the single-center design and relatively modest sample size, and multicenter replication with longer-term outcomes is warranted before broad guideline adoption.