Efficacy and safety of ciprofol for agitation and delirium in the ICU: A multicenter, single-blind, 3-arm parallel randomized controlled trial study protocol

Abstract

BackgroundAgitation is very common in the intensive care unit (ICU). The causes include pain, delirium, underlying disease, withdrawal syndrome, and some drug treatments. The practical goal of ICU treatment is to find an appropriate sedation regimen to reduce pain, restlessness, and delirium. Previous trials have examined the use of dexmedetomidine, but no trials have evaluated the efficacy and safety of ciprofol, a new sedative drug.MethodsThis study was a multicenter, single-blind, 3-arm parallel randomized controlled trial. ICU patients aged ≥ 18 years with agitation and delirium who met the eligibility criteria were included. The main outcome was the proportion of patients who needed additional study medication or midazolam due to agitation within 4 h after the first intravenous injection of the study medication. The secondary outcomes included the pass rate as indicated by a Richmond Agitation-Sedation Scale (RASS) score < +1, the effectiveness rate of improving delirium symptoms, the number of recurrences of agitation within 24 h, the incidence of rescue treatment, the dose and cost of analgesic and sedative drugs, the length and cost of ICU stay, and the 30-day survival period. The safety evaluation included the incidence of adverse events (hypotension, bradycardia, hypoxia, etc.) and the rate of endotracheal intubation. The subjects were randomly assigned to receive ciprofol, dexmedetomidine, or normal saline at a ratio of 1:1:1. The rates of additional drug administration within 4 h after the first injection of the study drug in the three groups were 40, 50, and 90%, respectively. A total sample size of 81 subjects was required to reach 90% power and an α of 0.05. Considering a 20% loss rate, 102 patients were enrolled and randomly assigned to the three groups in equal proportions.Ethics and communicationThis trial was approved by the Ethics Committee of Dalian Municipal Central Hospital. The communication plan includes presentations at scientific conferences, scientific publications, and presentations to the public through non-professional media.Clinical trial registrationwww.ClinicalTrials.gov, identifier ChiCTR220006 2799.

Efficacy and safety of ciprofol versus propofol for induction and maintenance of general anesthesia: a systematic review and meta-analysis

“…Some have highlighted the safety and effectiveness of ciprofol in anesthesia induction, with a lower incidence of adverse events [ 26 ]. In contrast, others have noted that propofol remains a standard and safe choice for anesthesia induction [ 32 ].…”

ED50 of Ciprofol Combined with Sufentanil for Fiber Bronchoscopy of Different Patient Populations with Pulmonary Tuberculosis

“…Currently, the effectiveness and safety of ciprofol have been recognized [22][23][24], however, due to its short marketing time, there is no reference dose for the use of ciprofol in special populations with low immunity such as TB. Therefore, this study prospectively included TB patients and calculated the ED50 of ciprofol combined with 0.15 µg/kg sufentanil for beroptic bronchoscopy examination of non-elderly men, nonelderly women, elderly men, and elderly women with TB by sequential test method, in order to provide a reliable basis for the effectiveness of ciprofol.…”

Exploring Ciprofol Alternatives: A Comprehensive Review of Intravenous Anesthesia Options

“…Research has indicated that ciprofol has a shorter half-life than dexmedetomidine and has demonstrated promising sedation and delirium control outcomes in ICU patients. It is anticipated to exhibit comparable efficacy to propofol while presenting fewer complications in ICU patients [ 41 , 42 ]. Both dexmedetomidine and ciprofol have served as focal points in clinical trials evaluating their efficacy and safety in sedation and anesthesia, each displaying potential advantages in various clinical scenarios.…”