Sedation Effects Produced by a Ciprofol Initial Infusion or Bolus Dose Followed by Continuous Maintenance Infusion in Healthy Subjects: A Phase 1 Trial.
Introduction: The effects of continuous infusions of ciprofol on its pharmacodynamic and pharmacokinetic properties and safety profiles in healthy Chinese subjects were evaluated.Methods: In this open-label, randomized, two-way cross-over study, subjects received initial doses of continuous ciprofol...
| Publicado en: | Advances in Therapy Vol. 38; no. 11; pp. 5484 - 5501 |
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| Autores principales: | , , , , , , , |
| Formato: | research Journal Article |
| Publicado: |
Springer Nature
Nov2021
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=153076557&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 153076557 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 0741238X 1XDX jtl: Advances in Therapy issn: 0741238X maglogo: N pubinfo: dt: Nov2021 vid: 38 iid: 11 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 153076557 152601127 153076557 NLM34559359 153076557 10.1007/s12325-021-01914-4 NLM34559359 153076557 ppf: 5484 ppct: 17 formats: tig: atl: Sedation Effects Produced by a Ciprofol Initial Infusion or Bolus Dose Followed by Continuous Maintenance Infusion in Healthy Subjects: A Phase 1 Trial. aug: au: Hu, Chao Ou, Xiaofeng Teng, Yi Shu, Shiqing Wang, Ying Zhu, Xiaohong Kang, Yan Miao, Jia affil: Clinical Trials Center, West China Hospital, Sichuan University, No. 37 Guoxue Lane, Wuhou District, 610041, Chengdu, China sug: subj: Anesthesia Propofol Adverse Effects Infusions, Intravenous Research Subjects Hypnotics and Sedatives Adverse Effects Crossover Design Human Comparative Studies Multicenter Studies Evaluation Research Validation Studies ab: Introduction: The effects of continuous infusions of ciprofol on its pharmacodynamic and pharmacokinetic properties and safety profiles in healthy Chinese subjects were evaluated.Methods: In this open-label, randomized, two-way cross-over study, subjects received initial doses of continuous ciprofol/propofol as an infusion for 30 min in part 1 (n = 8) and a bolus dose in part 2 (n = 8) followed by maintenance infusions for a total of 4 h in part 1 and 12 h in part 2. Each subject participated in both parts with a washout time of at least 40 h.Results: The safety and tolerability parameters of ciprofol were similar to those of propofol, and all treatment-emergent adverse events were mild. The incidences of injection pain and respiratory depression in subjects given ciprofol were lower than those receiving propofol. The pharmacokinetic parameters Cmax, tmax, t1/2, λz and MRT for ciprofol and propofol were similar, while CL, Vd and Vss were statistically significantly different. Pharmacodynamic parameters including the Richmond Agitation Sedation Scale and bispectral index profiles of ciprofol were similar to those of propofol.Conclusion: Ciprofol has potential for clinical application for continuous intravenous infusion to maintain sedation for 12 h with the same safety, tolerability and efficacy as propofol. pubtype: Academic Journal doctype: research Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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