Dataset Information

Efficacy and safety of ciprofol versus propofol for the induction of anesthesia in adult patients: a multicenter phase 2a clinical trial.

ABSTRACT:

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.

SUBMITTER: Zhu Q

PROVIDER: S-EPMC10147789 | biostudies-literature | 2023 Apr

REPOSITORIES: biostudies-literature

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Publications

Efficacy and safety of ciprofol versus propofol for the induction of anesthesia in adult patients: a multicenter phase 2a clinical trial.

Zhu Qianmei Q Luo Zhen Z Wang Xia X Wang Dongxin D Li Jun J Wei Xinchuan X Tang Jun J Yao Shanglong S Ouyang Wen W Zhang Wensheng W Zuo Yunxia Y Wang Xiao X Liu Jin J

International journal of clinical pharmacy 20230121 2

<h4>Background</h4>Ciprofol is a novel 2, 6-disubstituted phenolic derivative anesthetic that binds to the gamma-aminobutyric acid-A receptor.<h4>Aim</h4>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.<h4>Method</h4>A total of 109 patients undergoing selective non-emergency, non-cardiothoracic or non-neurosurgical surgery requiring tracheal intubation for gener ...[more]

PMID: 36680620

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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: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).

Project description:BackgroundHSK3486 (ciprofol) is a 2,6-disubstituted phenol derivative that acts like propofol as an agonist at the gamma-aminobutyric acid-A (GABA A ) receptor.ObjectiveTo investigate the efficacy and safety of HSK3486 for general anaesthesia induction and maintenance.DesignA single-blinded, randomised, parallel-group, phase 3 trial.SettingInvolving 10 study centres, from November 24, 2020 to January 25, 2021.PatientsA total of 129 patients undergoing nonemergency, noncardiothoracic, and nonneurosurgical elective surgery.InterventionPatients were randomly assigned at a 2:1 ratio into HSK3486 or propofol groups, to receive HSK3486 (0.4 mg kg -1 ) or propofol (2.0 mg kg -1 ) for induction before a maintenance infusion at initial rates of 0.8 and 5.0 mg kg -1 h -1 , and were adjusted to maintain a bispectral index (BIS) of 40-60 until the end of surgery.Main outcome measuresNoninferiority between the drugs was evaluated as the lower limit of the 95% confidence interval (CI) for the between-group difference in the success rate of anesthetic maintenance (primary outcome) >-8%. Secondary outcomes included successful anaesthetic induction, full alertness and spontaneous breathing recovery, time until leaving the postanaesthesia care unit and changes in BIS. Safety profiles were also measured.ResultsOf 129 enrolled patients, 128 completed the trial, with 86 in the HSK3486 group and 42 in the propofol group. The success rate for the maintenance of general anaesthesia was 100% for both groups, and noninferiority of HSK3486 was confirmed (95% CI -4.28% to 8.38%). No significant differences were found between the two groups of patients with regard to secondary outcomes (all P > 0.05). There appeared to be a comparable incidence of treatment for emergency adverse events (TEAEs) (80.2% vs. 81.0%, P = 1.000) and drug-related TEAEs (57.0% vs. 64.3%, P = 0.451) in the HSK3486 and propofol groups.ConclusionHSK3486 had a noninferior efficacy profile compared to propofol, exhibiting excellent tolerance.Trial registrationClinicaltrials.gov, identifier: NCT04511728.

Project description:ObjectiveRemimazolam besylate and Ciprofol are newer sedatives used in minor surgeries. Propofol is a classic drug mainly used for short surgeries. This trial was conducted to compare the efficacy and safety of remimazolam besylate, ciprofol, and propofol during hysteroscopic surgeries.MethodsPatients undergoing hysteroscopy were randomly assigned to receive remimazolam besylate (Group R), ciprofol (Group C), or propofol (Group P). A total of 194 patients were assessed for eligibility. One patient in Group P was excluded because the operation had timed out of 60 min. Patients all in Group R、Group C and Group P received an induction dose of 0.2 mg/kg remimazolam besylate、0.4 mg/kg ciprofol、2.0 mg/kg propofol seperately over 30 s. A corresponding dosage of 1 mg/kg/h、0.6-1.2 mg/kg/h and 3.0-6.0 mg/kg/h was given by continuous intravenous infusion to maintain a BIS of 40-60 till the end of the surgery. The incidence rates of body movement, respiratory depression, and adverse effects were compared among the groups.ResultsThe incidence of injection pain was much higher in Group P (64.1%) than that in Group R (3.4%) and Group C (3.2%, both P < 0.001). The onset time was significantly shorter in Group P than that in Group R and Group C (both P < 0.01). The awakening time (MOAA/S score = 3) was longest in Group R, followed by Groups C and Group P (P < 0.01). The time to complete recovery (MOAA/S score = 5) has no significantly difference between Group C and Group P, whereas the onset time was significantly shorter in Group R (P < 0.01). The number of body movements was significantly higher in Group R than that in Group C and Group P (P < 0.01). The incidence of hypotension was significantly lower in Group R than that in Group C and Group P (both P < 0.01). The rate of respiratory inhibition was significantly lower in Group R and Group C than that in Group P (both P < 0.05).ConclusionConsidering jointly the safety and efficacy, ciprofol seems to be the best choice for sedation.

Dataset Information

Efficacy and safety of ciprofol versus propofol for the induction of anesthesia in adult patients: a multicenter phase 2a clinical trial.

Background

Aim

Method

Results

Conclusion

Trial registration

Publications

Efficacy and safety of ciprofol versus propofol for the induction of anesthesia in adult patients: a multicenter phase 2a clinical trial.

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