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Title:
Efficacy and safety of ciprofol versus propofol for the induction of anesthesia in adult patients: a multicenter phase 2a clinical trial | International Journal of Clinical Pharmacy
Description:
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.
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Keywords {🔍}
propofol, ciprofol, dose, mgkg, patients, induction, pubmed, anesthesia, article, study, google, scholar, group, cas, groups, aes, sedation, general, min, clinical, trial, bolus, safety, phase, time, part, moaas, wang, surgery, injection, efficacy, significant, doses, administration, table, central, success, rate, topup, china, initial, required, escalation, supplementary, single, pain, hospital, blood, clin, eyelash,
Topics {✒️}
health-common terminology criteria article download pdf end-tidal carbon dioxide physical status i-ii integrated pharmacokinetic-pharmacodynamic model target-controlled infusion propofol central south university gamma-aminobutyric acid full access equivalent sedation/anesthesia profile propofol-related infusion syndrome gov/ftp1/ctcae/ctcae_4 participating medical centers tongji medical college sample size calculation randomized controlled trials dose escalation + expansion study phase 2a study privacy choices/manage cookies comparable anesthesia/sedation profiles secondary outcomes included intensive care units 0 mg/kg propofol group 4 mg/kg ciprofol group 5 mg/kg ciprofol group clinical pharmacy aims real clinical settings randomly controlled trial required tracheal intubation trial termination criteria 6-disubstituted phenol derivative jiangsu nhwa pharmaceutical yichang humanwell pharmaceutical wenzhou medical university 4 mg/kg ciprofol selected trigger trial termination dose ranges investigated 6-disubstituted phenol derivatives previous clinical experience secondary end-points equally potent dose primary end-point pulse oxygen saturation pre-oxygenation started qtcf interval prolongation neuroendocrine stress response obtain permission directly initial escalation dosage alternative sedation drugs arterial blood pressure
Questions {❓}
- Does propofol have advantages over isoflurane for sufentanil supplemented anesthesia in children for strabismus surgery?
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headline:Efficacy and safety of ciprofol versus propofol for the induction of anesthesia in adult patients: a multicenter phase 2a clinical trial
description:Ciprofol is a novel 2, 6-disubstituted phenolic derivative anesthetic that binds to the gamma-aminobutyric acid-A receptor. 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. 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). 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. 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. Clinicaltrials.gov, NCT03698617, retrospectively registered.
datePublished:2023-01-21T00:00:00Z
dateModified:2023-01-21T00:00:00Z
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Anesthesia
Ciprofol
Propofol
Sedation
Tracheal intubation
Internal Medicine
Pharmacy
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headline:Efficacy and safety of ciprofol versus propofol for the induction of anesthesia in adult patients: a multicenter phase 2a clinical trial
description:Ciprofol is a novel 2, 6-disubstituted phenolic derivative anesthetic that binds to the gamma-aminobutyric acid-A receptor. 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. 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). 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. 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. Clinicaltrials.gov, NCT03698617, retrospectively registered.
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Propofol
Sedation
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Internal Medicine
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