Efficacy and safety of ciprofol for the sedation/anesthesia in patients undergoing colonoscopy: Phase IIa and IIb multi-center clinical trials

Teng, Yi; Ou, Mengchan; Wang, Xiao; Zhang, Wensheng; Liu, Xiao; Liang, Yong; Li, Kuixiang; Wang, Yaping; Ouyang, Wen; Weng, Hao; Li, Jun; Yao, Shanglong; Ji, Meng; Shangguan, Wangning; Zuo, Yong; Zhu, Tao; Liu, Bin; Liu, Jin

doi:10.1016/j.ejps.2021.105904

Cited by 72 publications

(137 citation statements)

References 23 publications

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“…after 3 min (± 5 s). Previous phase 2 [ 22 ] and phase 3 (NCT03674008, on submission) studies on sedation for gastrointestinal endoscopy procedures demonstrated that the initial dose of 0.4 mg/kg HSK3486 was comparable to 2.0 mg/kg propofol. Because of the similar duration and administration method during gastrointestinal endoscopy procedures, the HSK3486 0.4 mg/kg and positive control propofol 2.0 mg/kg doses were also selected for patients undergoing fiberoptic bronchoscopy in the present trial.…”

Section: Methodsmentioning

confidence: 99%

“…Phase 2 [ 22 ] and phase 3 trials (clinicaltrials.gov, NCT03674008, on submission) for gastrointestinal endoscopy procedures demonstrated the efficacy and safety of HSK3486 in patients undergoing endoscopy. The duration of anesthesia/sedation in patients undergoing fiberoptic bronchoscopy was similar to that of gastrointestinal endoscopy, which is generally 10–30 min and the drug administration methods are also similar, which is an initial intravenous (i.v.)…”

Section: Introductionmentioning

confidence: 99%

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Efficacy and Safety of HSK3486 for Anesthesia/Sedation in Patients Undergoing Fiberoptic Bronchoscopy: A Multicenter, Double-Blind, Propofol-Controlled, Randomized, Phase 3 Study

Luo

Zhang

et al. 2022

CNS Drugs

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Background Fiberoptic bronchoscopy is a complex procedure with the need for sufficient patient anesthesia/sedation while maintaining safety. This trial aimed to evaluate the efficacy, safety, and pharmacokinetics of HSK3486 during fiberoptic bronchoscopy. Methods This multicenter, double-blind, randomized, non-inferiority, parallel-group phase 3 trial was conducted in patients who underwent fiberoptic bronchoscopy. Patients randomly received HSK3486 0.4 mg/kg (N = 134) or propofol 2.0 mg/kg (N = 133). The primary efficacy endpoint was the successful rate of fiberoptic bronchoscopy, and secondary efficacy endpoints included successful induction of anesthesia/sedation, duration, time to being fully alert, and time to patient discharge. Safety assessments and drug concentrations were also measured. Results A total of 267 patients completed fiberoptic bronchoscopy, with a success rate of 100% and a 95% confidence interval of − 2.8 to 2.8% for the difference between the groups, which met the predesigned criteria of > − 8%, confirming the noninferiority of anesthesia/sedation produced by HSK3486 compared to propofol. Among the secondary efficacy endpoints, only time to full alertness (median 8.50 vs. 6.00 min, P = 0.012) and time to discharge (median 13.00 vs. 9.87 min, P = 0.002) were slightly longer in the HSK3486 group. The incidence of adverse events was significant lower in the HSK3486 group (52.6 vs. 76.5%, P < 0.001) mainly because of less pain on injection (4.4 vs. 39.4%, P < 0.001) compared to the propofol group. HSK3486 had a similar terminal elimination half-life as propofol. Conclusions HSK3486 exhibited non-inferiority anesthesia/sedation compared to propofol in patients undergoing fiberoptic bronchoscopy, and had a good safety profile with a lower incidence of pain on injection. Trial Registration Clinicaltrials.gov, NCT04111159, registered on

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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Efficacy and Safety of HSK3486 for Anesthesia/Sedation in Patients Undergoing Fiberoptic Bronchoscopy: A Multicenter, Double-Blind, Propofol-Controlled, Randomized, Phase 3 Study

Luo

Zhang

et al. 2022

CNS Drugs

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“…These studies showed that ciprofol was safe and well tolerated by subjects. The PD properties of ciprofol doses used for induction and maintenance of anesthesia were similar to those of propofol, with the advantage that ciprofol produced a lower incidence of injection pain [17][18][19]. The effects of ciprofol on respiration, blood pressure and heart rate were not inferior to those elicited by propofol [17,19].…”

Section: Introductionmentioning

confidence: 99%

Sedation Effects Produced by a Ciprofol Initial Infusion or Bolus Dose Followed by Continuous Maintenance Infusion in Healthy Subjects: A Phase 1 Trial

Teng

et al. 2021

Adv Ther

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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, twoway 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 C max , t max , t 1/2 , kz and MRT for ciprofol and propofol were similar, while CL, V d and V ss 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.

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“…Subsequent phase II and III studies in patients undergoing gastrointestinal endoscopy and fiberoptic bronchoscopy described non-inferiority in the success rate of the procedure of bolus doses of ciprofol compared to bolus doses of propofol. The main advantage of ciprofol in these studies was a lower incidence of pain on injection in patients who received ciprofol [ 39 , 40 ]. A phase III trial is planned which will compare ciprofol to propofol for intensive care sedation [ 41 ].…”

Section: New Hypnotic Agentsmentioning

confidence: 99%

What’s New in Intravenous Anaesthesia? New Hypnotics, New Models and New Applications

Vellinga

Valk

Absalom

et al. 2022

JCM

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New anaesthetic drugs and new methods to administer anaesthetic drugs are continually becoming available, and the development of new PK-PD models furthers the possibilities of using arget controlled infusion (TCI) for anaesthesia. Additionally, new applications of existing anaesthetic drugs are being investigated. This review describes the current situation of anaesthetic drug development and methods of administration, and what can be expected in the near future.

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Efficacy and safety of ciprofol for the sedation/anesthesia in patients undergoing colonoscopy: Phase IIa and IIb multi-center clinical trials

Cited by 72 publications

References 23 publications

Efficacy and Safety of HSK3486 for Anesthesia/Sedation in Patients Undergoing Fiberoptic Bronchoscopy: A Multicenter, Double-Blind, Propofol-Controlled, Randomized, Phase 3 Study

Efficacy and Safety of HSK3486 for Anesthesia/Sedation in Patients Undergoing Fiberoptic Bronchoscopy: A Multicenter, Double-Blind, Propofol-Controlled, Randomized, Phase 3 Study

Sedation Effects Produced by a Ciprofol Initial Infusion or Bolus Dose Followed by Continuous Maintenance Infusion in Healthy Subjects: A Phase 1 Trial

What’s New in Intravenous Anaesthesia? New Hypnotics, New Models and New Applications

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