Ciprofol

Propofol is the preferred sedative for painless hysteroscopy and other procedures due to its fast onset and short duration. However, its limitations, including injection pain, respiratory depression, blood pressure decline, and bradycardia, cannot be disregarded. Ciprofol, a new short-acting gamma-aminobutyric acid receptor agonist, has shown effectiveness and safety in painless gastrointestinal endoscopy. This study aims to demonstrate that ciprofol is not inferior to propofol in terms of sedation efficacy for painless hysteroscopy.

A randomized study was conducted with 124 women to evaluate the anesthetic effect of ciprofol during outpatient painless hysteroscopy. The primary outcome assessed was the success rate of hysteroscopy, while secondary indicators included induction and recovery time, injection pain, tidal volume and respiratory rate. Safety indicators comprised hypotension, hypoxemia, and sinus bradycardia.

A total of 124 patients were enrolled in the study, with 62 in each group. The success rate of hysteroscopy was 100% in both groups. Patients in the ciprofol group had higher diastolic pressure, pulse oxygen saturation levels and minute breathing during surgery than patients in the propofol group, but their induction time and recovery time were longer. The proportion of patients in the propofol group who reported pain during intravenous anesthesia was 41.935%, which was significantly higher than that of patients in the ciprofol group (1.613%).

During painless hysteroscopy, ciprofol demonstrates non-inferiority to propofol in terms of anesthetic efficacy. Despite slightly longer induction and recovery times, ciprofol results in lower instances of injection pain and less impact on respiration and circulation compared to propofol.

Clinical trial Registration Identifier: NCT06172140.

The intravenous pharmacotherapy in patients with critically ill and perioperative intravenous anesthesia is extremely challenging due to the large number of drugs administered. In-line incompatibility remains a significant safety concern. We therefore evaluated the physico- chemical compatibility of combinations of ciprofol injection with cardiovascular drugs during simulated Y-site administration frequently used in intensive care unit setting or intravenous anesthesia. Ciprofol injection was mixed with clinical concentrations of dopamine, sodium nitroprusside, dobutamine, phentolamine, papaverine, nitroglycerin, metaraminol and methoxamine solution at a 1:1 vol ratio under ambient conditions (25 ± 1 °C). Physicochemical compatibility changes in appearance, pH values, Zeta potential, particle size/polydispersity index (PDI), osmotic pressure, and relative percentage content are observed at predetermined time points (0, 2, 4, 6, and 8 h). During the 8-hour study period, the pH values change of all drug mixture remained within ±0.4. The relative drug concentration was maintained between 95 % and 105 %. The mean particle size was in the range of 200 to 220 nm, with a PDI below 0.2. Osmotic pressure changes were consistently <6 %. Notably, the Zeta potential of the metaraminol-ciprofol mixture exhibited a variation exceeding ±10 mV. Microscopic imaging analysis showed that the droplet sizes of dopamine-ciprofol, metaraminol-ciprofol, and papaverine-ciprofol mixtures, increased significantly. Based on this studies, ciprofol injection demonstrated compatibility and stability when administered via Y-site infusion with sodium nitroprusside, dobutamine, methoxamine, phentolamine, and nitroglycerin for up to 8 h at room temperature. However, the combination of ciprofol with dopamine, metaraminol, or papaverine was incompatibility during infusion. pH is a significant factor that could potentially influence the stability and compatibility of the combinations. Clinical strategies such as the use of inline filters and post-infusion irrigation tubes can prevent these risks.