{"title":"The 90% effective dose of ciprofol and propofol with S-ketamine for painless abortion: a randomized, double-blind, sequential dose-finding trial.","authors":"Qiang Tao, Qiao Shi, Tao Xu, Shanshan Ye","doi":"10.1177/20420986251328673","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Unlike the propofol-opioids combination, a single dose of S-ketamine with propofol achieves the same anesthetic effects while effectively minimizing adverse reactions in painless abortion. Ciprofol, a novel analog of propofol, has distinct advantages, its application in painless abortion is underexplored.</p><p><strong>Objectives: </strong>To investigate a 90% effective dose (ED<sub>90</sub>) of ciprofol and propofol with S-ketamine for painless abortion.</p><p><strong>Design: </strong>This prospective biased coin up-and-down (BCUD) sequential dose-finding study aimed to estimate the ED<sub>90</sub> of ciprofol when administered with 0.15 mg/kg S-ketamine in painless abortion while comparing adverse effects incidence with the ED<sub>90</sub> of propofol when combined with the same dose of S-ketamine.</p><p><strong>Methods: </strong>Eighty patients were recruited and randomly allocated to either ciprofol or propofol groups, with initial doses of 0.375 mg/kg and 1.5 mg/kg, respectively. The dose for the subsequent patient in the study was based on the response of the preceding patient, following the BCUD design. The study estimated the ED<sub>90</sub> using isotonic regression. Secondary outcomes, including the incidence of injection pain, vital signs, and adverse events, were recorded and compared between the two groups.</p><p><strong>Results: </strong>The ED<sub>90</sub> of ciprofol with 0.15 mg/kg S-ketamine was 0.498 mg/kg (95% confidence interval: 0.498-0.510), while the ED<sub>90</sub> of propofol with 0.15 mg/kg S-ketamine was 1.99 mg/kg (95% confidence interval: 1.98-2.16). Patients in the ciprofol group had a lower incidence of respiratory pause (7.5% vs 52.5%; <i>p</i> < 0.001). Other adverse events and recovery time were comparable between groups.</p><p><strong>Conclusion: </strong>Compared to propofol and S-ketamine combination, ciprofol and S-ketamine are equally effective with reduced respiratory depression. Thus, clinicians should consider a dose of 0.5 mg/kg ciprofol with 0.15 mg/kg S-ketamine for painless abortion.</p><p><strong>Trial registration: </strong>http://www.chictr.org.cn; ChiCTR2400086522; July 5, 2024.</p>","PeriodicalId":23012,"journal":{"name":"Therapeutic Advances in Drug Safety","volume":"16 ","pages":"20420986251328673"},"PeriodicalIF":3.4000,"publicationDate":"2025-03-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11946288/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Therapeutic Advances in Drug Safety","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/20420986251328673","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"Q2","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Unlike the propofol-opioids combination, a single dose of S-ketamine with propofol achieves the same anesthetic effects while effectively minimizing adverse reactions in painless abortion. Ciprofol, a novel analog of propofol, has distinct advantages, its application in painless abortion is underexplored.
Objectives: To investigate a 90% effective dose (ED90) of ciprofol and propofol with S-ketamine for painless abortion.
Design: This prospective biased coin up-and-down (BCUD) sequential dose-finding study aimed to estimate the ED90 of ciprofol when administered with 0.15 mg/kg S-ketamine in painless abortion while comparing adverse effects incidence with the ED90 of propofol when combined with the same dose of S-ketamine.
Methods: Eighty patients were recruited and randomly allocated to either ciprofol or propofol groups, with initial doses of 0.375 mg/kg and 1.5 mg/kg, respectively. The dose for the subsequent patient in the study was based on the response of the preceding patient, following the BCUD design. The study estimated the ED90 using isotonic regression. Secondary outcomes, including the incidence of injection pain, vital signs, and adverse events, were recorded and compared between the two groups.
Results: The ED90 of ciprofol with 0.15 mg/kg S-ketamine was 0.498 mg/kg (95% confidence interval: 0.498-0.510), while the ED90 of propofol with 0.15 mg/kg S-ketamine was 1.99 mg/kg (95% confidence interval: 1.98-2.16). Patients in the ciprofol group had a lower incidence of respiratory pause (7.5% vs 52.5%; p < 0.001). Other adverse events and recovery time were comparable between groups.
Conclusion: Compared to propofol and S-ketamine combination, ciprofol and S-ketamine are equally effective with reduced respiratory depression. Thus, clinicians should consider a dose of 0.5 mg/kg ciprofol with 0.15 mg/kg S-ketamine for painless abortion.
Trial registration: http://www.chictr.org.cn; ChiCTR2400086522; July 5, 2024.
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Therapeutic Advances in Drug Safety delivers the highest quality peer-reviewed articles, reviews, and scholarly comment on pioneering efforts and innovative studies pertaining to the safe use of drugs in patients.
The journal has a strong clinical and pharmacological focus and is aimed at clinicians and researchers in drug safety, providing a forum in print and online for publishing the highest quality articles in this area. The editors welcome articles of current interest on research across all areas of drug safety, including therapeutic drug monitoring, pharmacoepidemiology, adverse drug reactions, drug interactions, pharmacokinetics, pharmacovigilance, medication/prescribing errors, risk management, ethics and regulation.
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