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ObjectiveThe research is to explore the half effective dose (ED50) and 95% effective dose (ED95) of ciprofol with intraperitoneal injection of 8-week-old C57BL/6J adult mice, which will provide experimental basis for the reasonable dose design of ciprofol in preclinical basic research.MethodsC57BL/6J mice were selected and divided into 8 dose groups (50, 55, 60, 65, 70, 80, 90, 100 mg/kg), with 12 males and 12 females in each group. The ciprofol was administered by intraperitoneal injection, and the latency of loss of righting reflex (LORR) and recovery time of righting reflex (RORR) were recorded. Probit regression analysis was used to calculate the ED50 and ED95 values of ciprofol anesthesia in mice.ResultsThere was a significant positive correlation between the dose of ciprofol and the positive rate of anesthesia in mice, and the recovery time of anesthesia was prolonged with the increase of dose. The ED50 of ciprofol in anesthesia was 56.014 mg/kg for male and 54.783 mg/kg for female, and the ED95 was 91.622 mg/kg for male and 82.212 mg/kg for female. There was no significant difference in the anesthetic dose between male and female mice.ConclusionIn this study, the ED50 and ED95 of ciprofol in male and female mice was determined. Our results demonstrate that ciprofol induces a dose-dependent anesthetic effect in mice, but gender has no significant impact on its efficacy. Collectively, these data provide a critical dosimetric basis for the standardized application of ciprofol in preclinical research.

ObjectiveThis randomized controlled trial aimed to compare the effects of three anesthetic regimens—desflurane + 0.9% saline (DS), desflurane + ciprofol (DC), and desflurane + esketamine (DE)—on early postoperative neurocognitive recovery and perioperative adverse events in patients undergoing endovascular coiling for intracranial aneurysms.MethodsThis randomized controlled trial enrolled 210 patients scheduled for urgent endovascular coiling of intracranial aneurysms. Patients were randomly assigned in a 1:1:1 ratio to receive DS, DC, or DE. Neurocognitive function was evaluated using the Montreal Cognitive Assessment (MoCA) before surgery, on postoperative day 1 (POD 1), and on postoperative day 5 (POD 5). Secondary outcomes included the incidence of postoperative nausea and vomiting (PONV), dizziness, numerical rating scale (NRS) pain scores, and the requirement for rescue antiemetic medication. This study was registered at the Chinese Clinical Trial Registry (ChiCTR2500097866).ResultsThe MoCA scores improved significantly over time across all groups (p < 0.001), with no significant differences in neurocognitive recovery trajectories among groups (interaction effect, p = 0.196; group effect, p = 0.729). The incidence of PONV differed significantly: 10.3% in the DC group, 17.9% in the DE group, and 44.9% in the DS group (p < 0.001). The DC group also exhibited the lowest incidence of dizziness (8.8%) and the lowest metoclopramide requirement (p = 0.012). Postoperative pain scores were significantly lower in the DE group than in the DC group (adjusted p = 0.026).ConclusionIn patients undergoing endovascular coiling for intracranial aneurysms, desflurane-based anesthesia supplemented with ciprofol or esketamine does not compromise early neurocognitive recovery. Desflurane plus ciprofol effectively reduces PONV and dizziness, whereas desflurane plus esketamine provides superior analgesia. These findings support personalized, symptom-targeted anesthetic strategies to enhance perioperative safety and recovery.

Ciprofol, a newer entrant with similarities to propofol, has shown promise with a potentially improved safety profile, making it an attractive alternative for induction of general anesthesia. This meta-analysis aimed to assess the safety and efficacy of ciprofol compared with propofol during general anesthesia induction. A comprehensive literature search was conducted using PubMed, Clinical Trial.gov, and Cochrane Library databases from inception to July 2023 to identify relevant studies. All statistical analyses were conducted using R statistical software version 4.1.2. Thirteen Randomized Controlled Trials (RCTs) encompassing a total of 1998 participants, were included in our analysis. The pooled analysis indicated that Ciprofol was associated with a notably lower incidence of pain upon injection [RR: 0.15; 95% CI: 0.10 to 0.23; I^2 = 43%, p < 0.0000001] and was non-inferior to propofol in terms of anesthesia success rate [RR: 1.00; 95% CI: 0.99 to 1.01; I^2 = 0%; p = 0.43]. In terms of safety, the incidence of hypotension was significantly lower in the ciprofol group [RR:0.82; 95% CI:0.68 to 0.98; I^2 = 48%; p = 0.03]. However, no statistically significant differences were found for postoperative hypertension, bradycardia, or tachycardia. In conclusion, Ciprofol is not inferior to Propofol in terms of its effectiveness in general anesthesia. Ciprofol emerges as a valuable alternative sedative with fewer side effects, especially reduced injection pain, when compared to Propofol. Propofol, frequently utilized as an anesthetic, provides swift onset and quick recovery. However, it has drawbacks such as a narrow effective dosage range and a high occurrence of adverse effects, particularly pain upon injection. Ciprofol, a more recent drug with propofol-like properties, has demonstrated promise and may have an improved safety profile, making it a compelling alternative for inducing general anesthesia. This meta-analysis compared the safety and effectiveness of Ciprofol with Propofol for general anesthesia induction in a range of medical procedures, encompassing thirteen Randomized Controlled Trials (RCTs) and 1998 individuals. The pooled analysis indicated that Ciprofol was associated with a notably lower incidence of pain upon injection [RR: 0.15; 95% CI: 0.10 to 0.23; I^2 = 43%, p < 0.0000001] and was non-inferior to propofol in terms of anesthesia success rate [RR: 1.00; 95% CI: 0.99 to 1.01; I^2 = 0%; p = 0.43]. In terms of safety, the incidence of hypotension was significantly lower in the ciprofol group [RR:0.82; 95% CI:0.68 to 0.98; I^2 = 48%; p = 0.03]. However, no statistically significant differences were found for hypertension, bradycardia, or tachycardia. In conclusion, ciprofol is equally effective at inducing and maintaining general anesthesia as propofol. When compared to propofol, ciprofol is a better alternative sedative for operations including fiberoptic bronchoscopy, gynecological procedures, gastrointestinal endoscopic procedures, and elective surgeries because it has less adverse effects, most notably less painful injections. •Our meta-analysis found that Ciprofol was associated with a significantly lower incidence of injection-related pain compared to Propofol.•Ciprofol also demonstrated a lower risk of hypotension during general anesthesia induction when compared to Propofol, indicating improved safety.•However, there were no statistically significant differences between Ciprofol and Propofol in terms of hypertension, bradycardia, or tachycardia events during induction, suggesting a comparable cardiovascular safety profile.

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, I 2 = 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, I 2 = 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).

Ciprofol (HSK3486; Haisco Pharmaceutical Group Co., Ltd., Chengdu, China), developed as a novel 2,6-disubstituted phenol derivative showed similar tolerability and efficacy characteristics as propofol when applicated as continuous intravenous infusion for 12 h maintenance sedation in a previous phase 1 trial. The phase 2 trial was designed to investigate the safety, efficacy, and pharmacokinetic characteristics of HSK3486 for sedation of patients undergoing mechanical ventilation. In this multicenter, open label, randomized, propofol positive-controlled, phase 2 trial, 39 Chinese intensive care unit patients receiving mechanical ventilation were enrolled and randomly assigned to a HSK3486 or propofol group in a 2:1 ratio. The HSK3486 infusion was started with a loading infusion of 0.1-0.2 mg/kg for 0.5-5.0 min, followed by an initial maintenance infusion rate of 0.3 mg·kg-1·h-1, which could be adjusted to an infusion rate of 0.06 to 0.80 mg·kg-1·h-1, whereas for propofol the loading infusion dose was 0.5-1.0 mg/kg for 0.5-5.0 min, followed by an initial maintenance infusion rate of 1.5 mg·kg-1·h-1, which could be adjusted to 0.3-4.0 mg·kg-1·h-1 to achieve -2 to +1 Richmond Agitation-Sedation Scale sedation within 6-24 h of drug administration. Of the 39 enrolled patients, 36 completed the trial. The median (min, max) of the average time to sedation compliance values for HSK3486 and propofol were 60.0 (52.6, 60.0) min and 60.0 (55.2, 60.0) min, with median difference of 0.00 (95% confidence interval: 0.00, 0.00). In total, 29 (74.4%) patients comprising 18 (69.2%) in the HSK3486 and 11 (84.6%) in the propofol group experienced 86 treatment emergent adverse events (TEAEs), the majority being of severity grade 1 or 2. Drug- and sedation-related TEAEs were hypotension (7.7% vs. 23.1%, P = 0.310) and sinus bradycardia (3.8% vs. 7.7%, P = 1.000) in the HSK3486 and propofol groups, respectively. The plasma concentration-time curves for HSK3486 and propofol were similar. HSK3486 is comparable to propofol with good tolerance and efficacy for sedation of Chinese intensive care unit patients undergoing mechanical ventilation in the present study setting. ClinicalTrials.gov, NCT04147416.

Ciprofol, a novel intravenous anesthetic, provides rapid recovery in patients undergoing colonoscopy. We aimed to examine the efficacy and safety of ciprofol in comparison with propofol for sedation or anesthesia in non-operating room settings including endoscopic submucosal dissection, endoscopic retrograde cholangiopancreatography, and flexible bronchoscopy (FB). Prospective, randomized, double-blind, parallel-group clinical trial. University-affiliated teaching hospital. We recruited 207 patients scheduled for an endoscopic procedure from October 2021 to December 2021. Patients were randomized into three groups according to the dose during induction (n = 69 each): 1) ciprofol 6 mg/kg/h, 2) ciprofol 8 mg/kg/h, or 3) propofol 40 mg/kg/h. Ciprofol or propofol was administered throughout the procedure. The primary outcome was the success rate of sedation or anesthesia for the procedures. Secondary outcomes included induction time, endoscope insertion time, recovery time, discharge time, incidence of drug-related adverse events (AEs), neurological and inflammatory outcomes. The procedure success rates in the three groups were 100%. The induction time in the 6 (3.3 ± 1.0 min) and 8 mg/kg/h (2.9 ± 0.6 min) ciprofol groups was longer than that in the propofol group (2.5 ± 0.6 min) only in patients undergoing FB (p = 0.004). The time for patients to be fully alert and discharged from the post-anesthesia care unit was comparable across the three groups (p > 0.05). The incidence of drug-related AEs in the propofol and 6 and 8 mg/kg/h ciprofol groups was 84.1%, 76.8%, and 79.7%. No pain on injection was reported by ciprofol groups. Neurological outcomes and inflammatory responses were comparable among the three groups. Ciprofol induced a level of sedation or anesthesia equivalent to that induced by propofol in non-operating room settings except for a prolonged induction time in patients undergoing FB. Ciprofol had a safety profile similar to that of propofol. No pain on injection was reported by ciprofol. •Ciprofol, a novel intravenous anesthetic, and propofol induced equivalent sedation or anesthesia in non-operating room settings.•Ciprofol had a similar safety profile to that of propofol.•No pain on injection was reported by the ciprofol groups.•Ciprofol and propofol anesthesia had similar neurological outcomes and inflammatory parameters.

Background Ciprofol is a recently developed, short-acting γ-aminobutyric acid receptor agonist sedative that is more potent than propofol, but there have been few clinical studies of this agent to date. Here, we sought to examine the safety and efficacy of ciprofol use for the induction of general anesthesia in individuals undergoing gynecological surgery. Methods Women between the ages of 18 and 60 years (ASA physical status 1 or 2) who were scheduled to undergo elective gynecological surgery under general anesthesia were randomly assigned to two equally sized groups in which anesthesia induction was performed using either ciprofol or propofol. General anesthesia induction success rates were the primary outcome for this study, while secondary outcomes included changes in BIS during the 10 min following the first administration of the study drug, the duration of successful induction, and adverse event incidence. Results A total of 120 women were included in the study. A 100% rate of successful induction was achieved in both the ciprofol and propofol groups, with no significant differences between these groups with respect to the duration of successful induction (34.8 ± 15.5 s vs 35.4 ± 9.5 s, P  = 0.832), the time to the disappearance of the eyelash reflex (33.7 ± 10.6 s vs 34.0 ± 6.5 s, P  = 0.860), or tracheal intubation (58.2 ± 31.1 s vs 53.9 ± 25.4 s, P  = 0.448). Adverse event rates, including intubation responses, were significantly lower in the ciprofol group as compared to the propofol group(20% vs 48.33%, P  = 0.0019). Ciprofol was associated with reduced injection pain relative to propofol (16.7% vs 58.3%, P  < 0.001). Conclusions Ciprofol exhibits comparable efficacy to that of propofol when used for the induction of general anesthesia in individuals undergoing gynecological surgery and is associated with fewer adverse events.

As a novel intravenous anaesthetic, ciprofol is widely used in clinical practice. However, its potential association with postoperative delirium (POD) is unclear. Silent information regulator factor 3(SIRT3) could regulate mitochondrial function, initiate mitochondrial autophagy, and has played an important role in maintaining normal neuronal cell function. This trial aimed to explore the effect of ciprofol on the pathogenesis of POD and whether SIRT3 had a correlation with the pathogenesis of POD. One hundred fourteen elderly patients scheduled for elective hip joint surgery were included in this randomized controlled, double blind study. The patients were randomly assigned at a 1:1 ratio to either the ciprofol group (Group C, induction of anaesthesia with 0.3 mg/kg ciprofol) or the propofol group (Group P, induction of anaesthesia with 1.5 mg/kg propofol). On postoperative days 1 and 3, the 3D-CAM scale was used to assess whether POD occurred in both groups of patients. No statistically significant difference was observed in the general condition of the patients in the two groups. Within the first 3 days after surgery, the incidence of POD was lower in Group C than in Group P (5.5% vs 20%; = 0.022). At 1 min of administration, ciprofol had less circulatory effects and a lower incidence of injection pain, but a higher incidence of muscle twitching than propofol. On postoperative day 1, SIRT3 expression was greater in Group C than in Group P ( = 0.028). Additionally, SIRT3 expression was found to be correlated with POD. The serum SIRT3 level on postoperative day 1 had an area under the receiver operating characteristic (ROC) curve of 0.8540 ( < 0.001), with a detection threshold of 1.565 ng/mL, yielding a sensitivity of 0.820 and a specificity of 0.900. In this study, we found that ciprofol was associated with a lower incidence of POD and had a minimal impact on circulatory function. SIRT3 expression and POD were correlated. A serum SIRT3 level less than 1.565 ng/mL on postoperative day 1 may indicate a likelihood of POD, highlighting its potential diagnostic value.

To evaluate the effects of different ciprofol doses on hemodynamics in patients undergoing cardiac surgery. 209 patients were randomly divided into four groups: 0.2 mg/kg etomidate group (group E, n = 50), 0.2 mg/kg, 0.3mg/kg, 0.4mg/kg ciprofol group (group A, n = 53, group B, n = 51, group C, n = 54). Mean arterial pressure (MAP), heart rate (HR), cardiac output (CO), stroke volume (SV), systemic vascular resistance (SVR), and bispectral index were recorded at the following time points: 5 minutes after entering the operating room (T ); before anesthesia induction (T ); immediately after induction (T ); 1 minute and 2 minutes after induction (T ~T ); at intubation (T ); 1 minute, 3 minutes, 5 minutes and 10 minutes after intubation (T ~T ); at skin incision (T ). The incidence of hypotension and bradycardia and the doses of vasoactive drugs were recorded. Compared with T , HR, MAP, SV, CO all decreased to varying degrees after administration, and the decrease time in Group B and Group C were earlier than that in other two groups ( < 0.05). SVR increased slowly after T in all groups, but there was no significant differences ( > 0.05). Compared with group E, the norepinephrine dose was significantly lower in groups A and B (both < 0.05). Group C showed a greater decline in CO and SV than the other three groups from T to T  ( < 0.05), while there was no significant difference between groups A and E in CO and groups A, B, and E in SV ( > 0.05). No significant differences were observed in MAP, SVR, and the incidences of hypotension and bradycardia among the four groups ( > 0.05). 0.2 mg/kg ciprofol has the least impact on hemodynamics in patients undergoing cardiac surgery, and reduced norepinephrine use.

Objective: Ciprofol is a novel 2,6-disubstituted phenol derivative that has improved pharmacokinetic and pharmacodynamic properties compared with propofol. This study was conducted to compare the efficacy and safety of ciprofol-remifentanil versus propofol-remifentanil for patients undergoing fiberoptic bronchoscopy. Methods: Overall, 92 patients undergoing fiberoptic bronchoscopy were included in this prospective, randomized, double-blind, non-inferiority trial and were equally divided into two groups (n = 46 each). Fentanyl (50 μg) was given 2 min before the intravenous infusion of 0.3 mg/kg of ciprofol or 1.2 mg/kg of propofol over a time period of 30 s. During anesthesia maintenance, 0.05–0.2 μg/kg/min of remifentanil combined with one-third to one-fourth of the initial dose of ciprofol or propofol was repeated at 2-min intervals, as required, to maintain a Modified Observer’s Assessment of Alertness and Sedation (MOAA/S) scale score <3. The primary outcome was the successful rate of fiberoptic bronchoscopy. Secondary outcomes included demographic characteristics, time metrics, hemodynamics, coughing severity, intubating conditions, lowest oxygen saturation, utilization of study drug doses, number of remedies (lidocaine and vasoactive drugs) used, satisfaction scores of both patients and the endoscopist, occurrence of intraoperative awareness, patients’ willing to repeat fiberoptic bronchoscopy, and occurrence and severity of adverse events. Results: The successful completion rate of fiberoptic bronchoscopy was 91.30% (42 of 46; 95% confidence interval [CI]: 82.80%–99.80%) in the ciprofol-remifentanil group and 89.13% (41 of 46; 95% CI: 79.80%–98.50%) in the propofol-remifentanil group. Though the clinically acceptable intubating condition was improved in the ciprofol-remifentanil group, this difference has no clinical statistical difference ( p > 0.05). No significant differences were noted between the two groups with respect to time metrics, consumption of fentanyl and remifentanil, or number of remedies (lidocaine and vasoactive drugs). Patients’ willingness to repeat fiberoptic bronchoscopy and the satisfaction of both patients and endoscopist were significantly higher in the ciprofol-remifentanil than in the propofol-remifentanil group ( p < 0.05). Compared with patients in the propofol-remifentanil group, patients in the ciprofol-remifentanil group had more stable hemodynamics. The lowest oxygen saturation was significantly higher in the ciprofol-remifentanil than in the propofol-remifentanil group ( p < 0.05). The numbers of patients who experienced pain on injection in the ciprofol-remifentanil group was significantly lower than the number in the propofol-remifentanil group ( p < 0.01). Severity of coughing, clinically acceptable severity of coughing, incidence of intraoperative awareness, and other adverse events were all similar between the two groups ( p > 0.05). Only four patients experienced grade 2 adverse events (severe hypotension in one patient in the ciprofol-remifentanil group and three patients in the propofol-remifentanil group; p > 0.05); they were treated with noradrenaline. Conclusion: Ciprofol-remifentanil was non-inferior to propofol-remifentanil with regard to successful sedation for flexible bronchoscopy, when used with pre-intravenous administration of 50 μg of fentanyl. At the same time, patients’ willingness to repeat flexible bronchoscopy and the satisfactions were all significantly improved.