Efficacy and safety of ciprofol versus propofol for the induction of anesthesia in adult patients: a multicenter phase 2a clinical trial

Abstract

Background Ciprofol is a novel 2, 6-disubstituted phenolic derivative anesthetic that binds to the gamma-aminobutyric acid-A receptor. Aim To determine the equally potent dose of ciprofol compared with propofol as an induction agent for general anesthesia in patients undergoing selective surgery, and to assess its safety. Method A total of 109 patients undergoing selective non-emergency, non-cardiothoracic or non-neurosurgical surgery requiring tracheal intubation for general anesthesia were enrolled. Ten patients per group were assigned to ciprofol-0.3, 0.4 and 0.5 mg/kg, and propofol-2.0 or 2.5 mg/kg groups, respectively to receive an intravenous bolus dose. An additional 20 patients were enrolled in the ciprofol-0.3, 0.5 or propofol-2.0 mg/kg groups. The primary outcome was the success rate of induction defined as a Modified Observer’s Assessment of Alertness/Sedation (MOAA/S) ≤ 1 after the initial bolus dose. The secondary outcomes included the time to reach MOAA/S ≤ 1, the time to loss of the eyelash reflex, the incidences and severity of adverse events (AEs). Results The success rates were 100% for all 5 groups. The mean time to MOAA/S ≤ 1 and the time to loss of the eyelash reflex were not different among the 5 groups, regardless of whether a top-up dose was needed. There were no significant differences in the incidences and severity of AEs in the dose ranges investigated of ciprofol vs. propofol. Conclusion The efficacy and safety of a single bolus dose of ciprofol-0.5 mg/kg for the general anesthesia induction in selective surgery patients was comparable to that of propofol-2.0 mg/kg. Trial registration Clinicaltrials.gov, NCT03698617, retrospectively registered.

Efficacy and safety of ciprofol for sedation in outpatient gynecological procedures: a phase III multicenter randomized trial

“…Our finding that the efficacy of ciprofol sedation was non-inferior to propofol was in line with previous studies. In a trial of 109 patients undergoing intubated general anesthesia, three different doses of ciprofol (0.3, 0.4, and 0.5 mg/kg) were used for anesthesia induction and achieved 100% success rate which was comparable to propofol (2.0 and 2.5 mg/kg) ( 5 ). The non-inferiority of ciprofol 0.4 mg/kg to propofol 2.0 mg/kg in anesthesia induction was also confirmed in a multi-center trial including 176 patients for elective surgery ( 10 ).…”

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

“…Ciprofol is a short-acting intravenous sedative based on the structural modi cation of propofol, whose main mechanism is to activate the postsynaptic GABA-A-Clchannel complex, which causes hyperpolarization of nerve cell membrane through chloride ion in ux, thus causing central nervous system inhibition [15][16][17]. The high selective binding ability of ciprofol to its receptor enables it to achieve the same sedative and anesthetic effects as propofol at a lower dose [18][19][20][21].…”

Pharmacokinetics and exposure–safety relationship of ciprofol for sedation in mechanically ventilated patients in the intensive care unit

“…Ciprofol PK data across 12 clinical trials 11 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 were included in the PopPK analysis. Four studies collected only venous blood samples and eight studies had both arterial and venous blood samples.…”

“…Ciprofol PK data across 12 clinical trials 11,[15][16][17][18][19][20][21][22] were included in the PopPK analysis. Four studies collected only mechanically ventilated patients in the intensive care unit (ICU) well-tolerated and safe?…”

“…[6][7][8] Ciprofol, a novel 2,6-disubstituted phenol derivative, is a new intravenous anesthetic agent for the induction and maintenance of anesthesia in clinical practice. 9,10 As a structural analog of propofol, ciprofol is a highly selective GABA A receptor potentiator 10,11 that is about four to five times more potent than propofol 9,10,12 and has fewer adverse events (AEs). 13 Ciprofol is approved for sedation and anesthesia during the surgical/procedure of nontracheal intubation, sedation and anesthesia in gynecological outpatient surgeries, induction and maintenance of general anesthesia, and sedation for patients in the intensive care unit in China.…”