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A systematic review and meta-analysis comparing the efficacy and safety of ciprofol (HSK3486) versus propofol for anesthetic induction and non-ICU sedation.

ABSTRACT: Background: Ciprofol (HSK3486) is a novel intravenous anesthetic agent that bears structural similarity to propofol and displays favorable pharmacodynamic characteristics such as rapid onset and offset. The meta-analysis aimed at comparing the efficacy and safety of ciprofol versus propofol in clinical practice. Methods: Medline, EMBASE, Google Scholar, Cochrane Library were searched from inception to April 2023. The primary outcome was success rate of sedation/anesthetic induction and differences in sedation/induction time. The secondary outcomes included risks of hemodynamic instability, respiratory complications, and pain on injection, as well as recovery profiles, satisfaction score, and top-up dose requirement. Results: Twelve RCTs (sedation: n = 6, anesthetic induction, n = 6, all conducted in China) involving 1,793 patients (age: 34-58 years) published from 2021 to 2023 were analyzed. Pooled results revealed no differences in success rate [risk ratio (RR) = 1, 95% confidence interval (CI): 0.99 to 1.01, I² = 0%, 1,106 patients, p = 1] and time required for successful anesthetic induction/sedation [mean difference (MD) = 7.95 s, 95% CI: -1.09 to 16.99, I² = 97%, 1,594 patients, p = 0.08]. The risks of top-up dose requirement (RR = 0.94, p = 0.48), cardiopulmonary complications [i.e., bradycardia (RR = 0.94, p = 0.67), tachycardia (RR = 0.83, p = 0.68), hypertension (RR = 1.28, p = 0.2), hypoxemia/pulmonary depression (RR = 0.78, p = 0.24)], and postoperative nausea/vomiting (RR = 0.85, p = 0.72), as well as discharge time (MD = 1.39 min, p = 0.14) and satisfaction score (standardized MD = 0.23, p = 0.16) did not differ significantly between the two groups. However, the ciprofol group had lower risks of hypotension (RR = 0.85, p = 0.02) and pain on injection (RR = 0.17, p < 0.00001) than the propofol group. The time to full alertness was statistically shorter in the propofol group (i.e., 0.66 min), but without clinical significance. Conclusion: Our results demonstrated similar efficacy between ciprofol and propofol for sedation and anesthetic induction, while ciprofol was associated with lower risks of hypotension and pain on injection. Future studies are warranted to evaluate the efficacy and safety of ciprofol in pediatric or the elderly populations. Systematic Review Registration: (https://www.crd.york.ac.uk/prospero/), identifier (CRD42023421278).

SUBMITTER: Hung KC

PROVIDER: S-EPMC10561285 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature

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A systematic review and meta-analysis comparing the efficacy and safety of ciprofol (HSK3486) versus propofol for anesthetic induction and non-ICU sedation.

Hung Kuo-Chuan KC Chen Jen-Yin JY Wu Shao-Chun SC Huang Po-Yu PY Wu Jheng-Yan JY Liu Ting-Hui TH Liu Chien-Cheng CC Chen I-Wen IW Sun Cheuk-Kwan CK

Frontiers in pharmacology 20230925

<b>Background:</b> Ciprofol (HSK3486) is a novel intravenous anesthetic agent that bears structural similarity to propofol and displays favorable pharmacodynamic characteristics such as rapid onset and offset. The meta-analysis aimed at comparing the efficacy and safety of ciprofol versus propofol in clinical practice. <b>Methods:</b> Medline, EMBASE, Google Scholar, Cochrane Library were searched from inception to April 2023. The primary outcome was success rate of sedation/anesthetic induction ...[more]

PMID: 37818194

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Project description:BackgroundCiprofol (HSK3486) is a novel gamma-aminobutyric acid type A (GABAA) receptor agonist that has attracted wide attention because of its lower injection pain and fewer adverse events. We summarized all available evidence and analyzed the efficacy and safety of ciprofol during procedural sedation and anesthesia induction.MethodsAn electronic search of PubMed, Embase, Cochrane Library, Web of Science, Google Scholar, Science Direct, the Chinese National Knowledge Infrastructure, Wan Fang Data, and the VIP Chinese Journal Service platform was conducted from inception of databases to March 1, 2023. Risk ratio (RR) and mean difference (MD) with 95 % confidence interval (CI) were used separately for binary categorical and continuous variables. We performed trial sequential analysis and the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) methodology to judge the certainty of evidence.ResultsFifteen randomized controlled trials with 2441 patients were included in this study. Ciprofol showed similar advantages to propofol in terms of induction success rate (RR = 1, 95 % CI = 0.99, 1.01, moderate certainty) and induction time (MD = 3.31, 95 % CI = -0.34, 6.95, low certainty), but did not increase the incidence of adverse events (RR = 0.88, 95 % CI = 0.78, 1.00, very low certainty), such as bradycardia (RR = 0.96, 95 % CI = 0.77, 1.21, high certainty), hypoxia (RR = 0.79, 95 % CI = 0.46, 1.37, p = 0.40, moderate certainty) and other adverse events. Although it may be associated with a longer time to be fully alert (MD = 1.22, 95 % CI = 0.32, 2.12, very low certainty), ciprofol significantly reduced injection pain (RR = 0.15, 95 % CI 0.09, 0.24, low certainty) and may have reduced the incidence of hypotension (RR = 0.77, 95 % CI = 0.63, 0.94, low certainty) and respiratory depression (RR = 0.29, 95 % CI = 0.15, 0.56, moderate certainty).ConclusionCiprofol and propofol had similar effects on most outcomes. While the time to full alertness may be prolonged, injection pain was significantly reduced, and hypotension and respiratory depression may be reduced compared with propofol. We believe that ciprofol is an effective alternative to intravenous anesthetic agents.

Project description:IntroductionPainless gastrointestinal endoscopy is being increasingly practised in the clinical field. The management and choice of sedation are important during the endoscopy procedure to reduce patient discomfort and facilitate high disease detection rates. Ciprofol is principally an agonist of the γ-aminobutyric acid type A receptor; it comprises the active ingredient HSK3486, which is similar to the currently used intravenous anaesthetic propofol in clinical practice. A systematic review and meta-analysis comparing ciprofol and propofol will be conducted to assess their efficacy and safety during endoscopy. Before starting the study, we describe the specific protocol of this systematic review.Methods and analysisThis protocol was prepared in accordance with the Preferred Reporting Items for Systematic Review and Meta-analysis Protocols 2015. The following databases will be searched: Embase, Cochrane Library, PubMed, Web of Science, Chinese Biomedical Literature Service System, China National Knowledge Infrastructure, Wanfang Database, China Science and Technology Journal Database and a clinical trial registry. The database search strategy will adopt a combination of subject words and free words. Randomised controlled trials related to ciprofol use for sedation during gastrointestinal endoscopy will also be included. Based on the inclusion and exclusion criteria, two researchers will independently screen the articles and extracted data. Following the qualitative evaluation of each study, analysis will be conducted using Review Manager software.Ethics and disseminationThe protocol for this systematic review and meta-analysis involves no individual patient data; thus, ethical approval is not required. This will be the first meta-analysis to assess the sedation efficacy of ciprofol and provide evidence to clinicians for decision-making. The results will be disseminated through conference presentations and publications in peer-review journals related to this field.Prospero registration numberCRD42022370047.

Project description:BackgroundPropofol is use widely used in anesthesia, known for its effectiveness, may lead to cardiopulmonary issues in some patients. Ciprofol has emerged as a possible alternative to propofol because it can achieve comparable effects to propofol while causing fewer adverse events at lower doses. However, no definitive conclusion has been reached yet. This meta-analysis aimed to evaluate the efficacy and safety of ciprofol versus propofol in adult patients undergoing elective surgeries under general anesthesia.MethodsWe searched PubMed, EMBASE, the Cochrane library, Web of Science, and Chinese National Knowledge Infrastructure (CNKI) to identify potentially eligible randomized controlled trials (RCT) comparing ciprofol with propofol in general anesthesia until September 30, 2023. The efficacy outcomes encompassed induction success rate, time to onset of successful induction, time to disappearance of eyelash reflex, and overall estimate means in Bispectral Index (BIS). Safety outcomes were assessed through time to full alertness, incidence of hypotension, incidence of arrhythmia, and incidence of injection-site pain. Continuous variables were expressed as mean difference (MD) with 95% confidence interval (CI), and dichotomous variables were expressed as risk ratio (RR) with 95% CI. Statistical analyses were performed using RevMan 5.4 and STATA 14.0. The quality of the evidence was rated through the grading of recommendations, assessment, development and evaluation (GRADE) system.ResultsA total of 712 patients from 6 RCTs were analyzed. Meta-analysis suggested that ciprofol was equivalent to propofol in terms of successful induction rate, time to onset of successful induction, time to disappearance of eyelash reflex, time to full alertness, and incidence of arrhythmia, while ciprofol was better than propofol in overall estimated mean in BIS (MD: -3.79, 95% CI: -4.57 to -3.01, p < 0.001), incidence of hypotension (RR: 0.63, 95% CI: 0.42 to 0.94, p = 0.02), and incidence of injection-site pain (RR: 0.26, 95% CI: 0.14 to 0.47, p < 0.001). All results were supported by moderate to high evidence.ConclusionsCiprofol may be a promising alternative to propofol because it facilitates achieving a satisfactory anesthesia depth and results in fewer hypotension and injection-site pain. However, we still recommend conducting more studies with large-scale studies to validate our findings because only limited data were accumulated in this study.Trial registrationPROSPERO 2023 CRD42023479767.

Project description:BackgroundThe role of ciprofol as a novel anesthetic in gastrointestinal endoscopic surgery is unclear. We conducted a systematic review and meta-analysis to evaluate the efficacy and safety of ciprofol for gastrointestinal endoscopy in patients aged over 65 years and under 65 years, aiming to provide evidence-based information for clinical decision-making.MethodsWe conducted a search for RCTs(randomized controlled trials) comparing ciprofol and propofol in gastrointestinal endoscopy on databases including PubMed, Embase, Cochrane Library, Web of Science, (China National Knowledge Infrastructure)CNKI, Wanfang, and Vipro Chinese Journal Service up to September 15, 2024. The required information was screened and extracted, and the quality of the included research literatures was assessed using the Cochrane Collaboration risk of bias assessment tool, and Meta-analysis of outcome metrics was performed using Revman 5.4 and Stata software.ResultsA total of 17 RCTs involving 2800 patients were included, with 1,450 patients in the ciprofol group and 1350 patients in the propofol group. The results of the meta-analysis indicated that there was no statistically significant difference in the sedation success rate or recovery time between the two groups across all age categories. In patients under 65 years old, the induction time of the ciprofol group (MD = 0.41 min, 95%CI: 0.04 min ∼ 0.78 min, P = 0.03) was longer than that in the propofol group. The incidences of hypotension (OR = 0.48, 95%CI: 0.32 ∼ 0.72, P = 0.004), bradycardia (OR = 0.66, 95%CI: 0.49 ∼ 0.87, P = 0.004), injection pain (OR = 0.08, 95%CI: 0.05 ∼ 0.15, P<0.0001), respiratory depression (OR = 0.21, 95%CI: 0.15 ∼ 0.30, P<0.0001), and hypoxemia (OR = 0.29, 95%CI: 0.20 ∼ 0.43, P<0.0001), in the ciprofol group were much lower than those in the propofol group.ConclusionMeta-analysis results indicate that, across various age groups, ciprofol demonstrates a higher safety profile and effectively reduces the incidence of postoperative (ADRs)adverse reactions compared to propofol. However, there is no significant difference in the sedative effects of the two agents. This study categorized elderly patients into subgroups, thereby providing a foundation for the application of ciprofol in gastrointestinal examinations of elderly patients. Consequently, we propose that ciprofol may serve as a safer alternative to intravenous anesthesia compared to propofol; However, this conclusion requires further validation through high-quality studies.

Project description:IntroductionFrom previous studies of pharmacodynamic data in mice, rats, beagle dogs and mini pigs, frequently in direct comparison to induction doses of propofol, ciprofol produced a rapid onset of anesthesia/sedation.MethodsA phase 1 study suggested potential clinical advantages of ciprofol as a sedation/anesthetic agent, with no evidence of drug-related toxicity. However, the sedation effects and safety of ciprofol in intensive care unit (ICU) patients with mechanical ventilation should be further confirmed in a phase 3 study with a larger cohort of patients. During a phase 3, non-inferiority, multicenter, single-blind, randomized, propofol controlled trial, Chinese ICU patients undergoing mechanical ventilation and requiring endotracheal intubation will be sedated for 6-24 h after randomization. Considering a success rate for ICU sedation of 99% for ciprofol and the positive control drug propofol, a total sample size of 120 subjects with mechanical ventilation will be required to achieve 80% power to determine non-inferiority with a margin of 8%. Finally, taking into account 10% losses, 135 patients will be enrolled and randomly assigned to ciprofol (90 cases) and propofol (45 cases) groups in a 2:1 ratio. The primary outcome will be the success rate of sedation satisfied by the following conditions: the time within the range of Richmond Agitation and Sedation Score (+ 1 ~ - 2) must account for ≥ 70% of the study drug administration time and without other rescue treatments. Secondary outcomes will include the average time to reach the sedation goal, study drug usage, rescue medication given per unit weight, extubation time, recovery time to full consciousness and nursing scores. Safety endpoints will include adverse events (AEs), drug related AEs and serious AEs.Planned outcomesThe results of this study will provide crucial information on the use of ciprofol for sedation of patients in ICUs.Trial registrationClinicalTrials.gov identifier, NCT04620031.

Project description:ObjectivesTo determine the effectiveness and safety of ciprofol for sedating patients in ICUs who required mechanical ventilation (MV).DesignA multicenter, single-blind, randomized, noninferiority trial.SettingTwenty-one centers across China from December 2020 to June 2021.PatientsA total of 135 ICU patients 18 to 80 years old with endotracheal intubation and undergoing MV, who were expected to require sedation for 6-24 hours.InterventionsOne hundred thirty-five ICU patients were randomly allocated into ciprofol ( n = 90) and propofol ( n = 45) groups in a 2:1 ratio. Ciprofol or propofol were IV infused at loading doses of 0.1 mg/kg or 0.5 mg/kg, respectively, over 4 minutes ± 30 seconds depending on the physical condition of each patient. Ciprofol or propofol were then immediately administered at an initial maintenance dose of 0.3 mg/kg/hr or 1.5 mg/kg/hr, to achieve the target sedation range of Richmond Agitation-Sedation Scale (+1 to -2). Besides, continuous IV remifentanil analgesia was administered (loading dose: 0.5-1 μg/kg, maintenance dose: 0.02-0.15 μg/kg/min).Measurements and main resultsOf the 135 patients enrolled, 129 completed the study. The primary endpoint-sedation success rates of ciprofol and propofol groups were 97.7% versus 97.8% in the full analysis set (FAS) and were both 100% in per-protocol set (PPS). The noninferiority margin was set as 8% and confirmed with a lower limit of two-sided 95% CI for the inter-group difference of -5.98% and -4.32% in the FAS and PPS groups. Patients who received ciprofol had a longer recovery time ( p = 0.003), but there were no differences in the remaining secondary endpoints (all p > 0.05). The occurrence rates of treatment-emergent adverse events (TEAEs) or drug-related TEAEs were not significantly different between the groups (all p > 0.05).ConclusionsCiprofol was well tolerated, with a noninferior sedation profile to propofol in Chinese ICU patients undergoing MV for a period of 6-24 hours.

Dataset Information

A systematic review and meta-analysis comparing the efficacy and safety of ciprofol (HSK3486) versus propofol for anesthetic induction and non-ICU sedation.

Publications

A systematic review and meta-analysis comparing the efficacy and safety of ciprofol (HSK3486) versus propofol for anesthetic induction and non-ICU sedation.

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