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Ciprofol (Cipepofol) currently has well-established clinical research data in adult Chinese patients, but there is a lack of reliable research data in pediatric patients. This study aimed to assess the age-specific plasma concentration, efficacy and safety profiles of cipepofol in pediatric patients aged 2-17 years during the induction and maintenance of general anesthesia. This was a single-arm, open-label, prospective, pragmatic study conducted in the Hunan Children's Hospital from May 10, 2023 to August 25, 2023, that involved pediatric patients undergoing elective surgery after the induction and maintenance of general anesthesia. Cipepofol was administered as an intravenous bolus injection of 0.6 mg/kg (patients aged 2-11 years) or 0.5 mg/kg (12-17 years) for induction, followed by an initial maintenance infusion of 1.2 mg/kg/h or 1.4 mg/kg/h, respectively. The primary endpoint-plasma concentration of cipepofol was measured using a validated high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) method. The age-specific plasma concentration, efficacy and safety profiles of cipepofol are summarized using descriptive statistics. All 38 enrolled patients completed the study, including 14 children aged 2-5 years, 12 children aged 6-11 years and 12 children aged 12-17 years. The trends of plasma concentration variations among patients in the three age groups were largely consistent. The success rates of anesthesia induction and maintenance for patients in the three groups were both 100%, and no patients required rescue medication. Children aged 2 to 5 years had the longest median durations of successful anesthetic induction (1.1 min) and eyelash reflection disappearance (1.2 min), while the median durations for patients aged 6-11 years and those aged 12-17 years (0.5 and 0.5 min) were similar. The median time to extubation and length of stay in the post-anesthesia care unit tended to be the longest in children aged 6-11 years (23.5 and 30.0 min) but were comparable for those aged 2-5 years (10.5 min and 20.0 min) and 12-17 years (11.0 and 20.0 min). The median time to full alertness tended to decrease with increasing age (33.7 vs 25.8 vs 22.7 min). A total of 4 (10.5%) patients experienced treatment-emergent adverse events in those aged 2-5 years or 12-17 years, with a severity of grade 1 or grade 2. Cipepofol had good safety for the induction and maintenance of general anesthesia in pediatric patients aged over 2 years. The dosing regimen with an intravenous bolus injection of 0.5 mg/kg for induction, followed by an initial maintenance infusion of 1.4 mg/kg/h was adequate for children aged 12-17 years; age-specific dose regimen for children aged 2-11 years should be improved by further large-scale prospective studies. ChiCTR2400085640, July 14, 2024, retrospectively registered.

This study aimed to compare the effects of fospropofol disodium and propofol on perioperative neurocognitive function in elderly patients undergoing total hip arthroplasty (THA), evaluating the non-inferiority of fospropofol disodium in preventing or reducing perioperative neurocognitive disorders (PND) and exploring optimal clinical anesthesia strategies. A total of 180 elderly patients (aged 65~80 years) scheduled for THA between November 2022 and November 2024 were randomly assigned to the fospropofol disodium group (Group F, n=90) or the propofol group (Group P, n=90). Cognitive function was assessed preoperatively (1 day before surgery) and postoperatively (1, 3, 7 days, and 1 month) using the Modified Mini-Mental State Examination (MMSE), 3-Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM), Digit Span Test (DST), Verbal Fluency Test (VFT), and Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE). The incidence of postoperative cognitive dysfunction (POCD) and delirium (POD), hemodynamic parameters, and adverse events were compared between the two groups. No significant differences were observed between the two groups in the incidence of POCD ( >0.05) or POD ( >0.05) at any postoperative time point. At the time point of 10 minutes after bone cement implantation (T4), the heart rate of patients in the Group F was higher than that of Group P ( < 0.0001). At the time of discharge from the PACU, the heart rate of patients in the Group F was lower than that of the Group P ( = 0.037). Group F exhibited higher mean arterial pressure (MAP) at the beginning of the operation ( =0.022) and a longer extubation time and waking time ( < 0.001) but had significantly lower incidences of injection pain ( =0.018) and postoperative nausea and vomiting ( =0.037). Binary logistic regression identified age as an independent risk factor for PND [OR=1.149, =0.006], while preoperative MMSE score was a protective factor [OR=0.693, = 0.002]. Fospropofol disodium may be a viable alternative in settings where injection pain and PONV are primary concerns, provided that hemodynamic stability is actively managed in elderly THA patients, with non-inferior efficacy in preventing PND compared to propofol and fewer adverse effects. Age and preoperative cognitive function are critical predictors of PND, warranting careful consideration in perioperative management.

Ciprofol, a novel γ-aminobutyric acid receptor agonist, outperforms propofol with minimal cardiovascular effects, higher potency, reduced injection pain, and a broader safety margin. Despite these advantages, ciprofol’s clinical research is still emerging. This study compares the median effective dose (ED 50 ) and adverse reactions of ciprofol and propofol, in conjunction with sufentanil, for suppressing cardiovascular responses during tracheal intubation. Fifty-three adult patients scheduled for tracheal intubation under general anesthesia were enrolled and randomly assigned to receive either ciprofol (Group C) or propofol (Group P), according to a random number table. Tracheal intubation was performed using a standardized laryngoscope and endotracheal tube. The Dixon’s up-and-down method was employed to determine the ED 50 and 95% effective dose (ED 95 ) of ciprofol and propofol in inhibiting cardiovascular responses during tracheal intubation. Based on the pilot study, the initial dose for ciprofol was set at 0.35 mg/kg (with a 0.01 mg/kg increment) and for propofol at 2.0 mg/kg (with a 0.1 mg/kg increment). Probit analysis was applied to derive dose-response curves, while adverse reactions were continuously monitored. A total of 54 participants were included, with 24 in group C (1 excluded) and 30 in group P. Probit analysis revealed that the ED 50 of ciprofol for inhibiting cardiovascular responses to tracheal intubation were 0.326 mg/kg (95% CI 0.304–0.337 mg/kg), and for propofol, 1.541 mg/kg (95% CI 1.481–1.599 mg/kg). The heart rate in group P was significantly higher than the group C at 1 minute ( p  = 0.026) and 3 minutes ( p  = 0.016) post-intubation. Systolic and diastolic blood pressures (SBP and DBP) decreased significantly before and after intubation compared to baseline values in both groups ( p < 0.05). Group C experienced significantly less injection pain ( p  = 0.001), although the incidence of other adverse effects was not statistically different between groups ( p > 0.05). Clinical Trial Registration : hppts://ClinicalTrials.gov; Identifier: NCT06095570(18/10/2023).

Background Ciprofol, a novel intravenous anesthetic, which has primarily been used for the induction and maintenance of general anesthesia in adults, is characterized by rapid onset, short duration of action, and quick and smooth recovery. However, the pharmacokinetic characteristics of continuous infusions and the correlation between the plasma concentration and the bispectral index (BIS) in elderly patients are still unknown. Method In this randomized, controlled study, thirty elderly patients (62–78 years old) undergoing elective gastrointestinal tumor resection were treated with propofol ( N  = 15) or ciprofol ( N  = 15) as sedatives during anesthesia. After induction, ciprofol/propofol was continuously infused intravenously until the end of the operation. Perioperative vital signs, injection pain, adverse events (AEs), BIS values, eyelid reflex disappearance times, and recovery times were recorded. The plasma concentrations of ciprofol and propofol were measured by liquid chromatography tandem mass spectrometry (LC‒MS/MS) and the pharmacokinetics were determined by noncompartmental analysis. Results Both drugs caused a decrease in blood pressure and heart rate after induction. Eight cases (53. 3%) of hypotension and 3 cases (20%) of bradycardia occurred in the propofol group, while 8 cases (53. 3%) of hypotension and 5 cases (33. 3%) of bradycardia occurred in the ciprofol group. At intubation, the ciprofol group experienced fewer fluctuations in blood pressure than the propofol group. Ciprofol resulted in only one case (6.7%) of mild injection pain, less than that produced by propofol (10/15, 66.7%) ( P  < 0.05). Anesthesia induction was successfully completed with both drugs, and there were no significant differences in eyelash reflex disappearance or recovery time between the two groups. The plasma concentrations during maintenance were relatively stable in both groups (propofol 1.78 ± 0.67 μg/mL, ciprofol 0.71 ± 0.23 μg/mL), and a suitable depth of sedation was achieved with a BIS of 40–60. The pharmacokinetic (PK) parameters for ciprofol are listed as follows: Maximum Plasma Concentration (Cmax) 6.02 ± 2.13 μg/ml; Time to Maximum Concentration (Tmax) 0.18 ± 0.62 min; Apparent Volume of Distribution (Vz) 3.96 ± 0.84 L/kg; Total Clearance (CL) 0.83 ± 0.14 L/h/kg; Half-life (t½) 3.47 ± 1.85 h; Area Under the Curve (AUC) 5000 ± 900 L/h/kg; Terminal Elimination Rate Constant (λz) 0.23 ± 0.07 1/h. Similar to propofol, the plasma concentration of ciprofol was linearly correlated with the BIS. Conclusion Ciprofol, a novel intravenous anesthetic, can be safely and effectively used in elderly patient continuous infusion with minimal injection pain. Plasma concentrations of ciprofol correlate well with BIS values, helping control sedation depth. For elderly patients undergoing gastrointestinal tumor surgery, an optimal maintenance dose of 0.8 mg/kg/h is recommended. Trial registration This clinical trial (registration No: ChiCTR2100047580, https://www.chictr.org.cn . The pre-registration date was June 20, 2021, and the review approval and official case solicitation began in December 2021; Retrospectively registered) was conducted in accordance with the World Medical Congress Declaration of Helsinki and Good Clinical Practice guidelines. All study subjects provided written informed consent. Highlights Ciprofol can be safely and effectively used in elderly patients for continuous infusion. The plasma concentration of ciprofol has a good correlation with the BIS value. Sedation level during ciprofol anesthesia can be controlled according to the BIS value.

Rationale The intravenous anesthetic propofol is known to induce positive mood effects during routine clinical use, suggesting it might be repurposed as an antidepressant, but also raising concerns about abuse potential. How propofol's acute effects vary by dose and with repeated infusions is unknown. Objectives This exploratory analysis aimed to (1) compare the immediate mood effects of propofol administered at two different doses, (2) describe how those mood effects change with repeated infusions, and (3) evaluate whether acute mood improvement predicts later antidepressant response. Methods Twenty-four adults with moderate-to-severe treatment-resistant depression were randomized into two dosing groups. Six low- or high-dose propofol infusions were administered under blinded conditions over a two-week period. Self-reported mood states were recorded before and after each infusion using the Positive and Negative Affect Schedule (PANAS-X). Abuse potential was evaluated with the Drug Effects Questionnaire (DEQ-5). Results At the first infusion, propofol induced acute improvements in PANAS-X Sadness, Fear, Joviality, and Serenity scales ( p  < 0.002), independent of dose. Over the series of six infusions, acute changes in Sadness, Fear, and Joviality, but not Serenity, diminished with infusion number ( p  < 0.002). The DEQ-5 \"want more\" rating decreased across infusions ( p  = 0.002). Changes in PANAS-X scales with the first infusion did not predict later improvement in depression severity ( p  > 0.05). Conclusion Cumulative changes in mood states observed with repeated infusions suggest that propofol engages adaptive mechanisms in mood circuitry. Subjective responses with repeated infusions do not indicate increasing potential for abuse in this patient population.

Background Intraoperation hypotension (IOH) is commonly observed in patients undergoing surgery under general anesthesia, and even a brief episode of IOH can lead to unfavorable outcomes. To reduce the risk, blood pressure is closely measured during general anesthesia, and norepinephrine (NE) is frequently administered if hypotension is detected. Despite its routine application, information on the dose-exposure-response relationship of NE remains limited. Additionally, quantification of the influence of general anesthesia on the pharmacokinetics (PK) of NE is lacking. Objective In this study, we aimed to describe NE PK in healthy volunteers and the influence of general anesthesia on its PK. Methods A single-center, cross-over study was conducted in healthy volunteers. The volunteers received a step-up NE dosing scheme (0.04, 0.08, 0.12, 0.16 and 0.20 mcg –1 /kg –1 /min –1 ) first in the awake state and then under general anesthesia. General anesthesia was administered using a propofol/remifentanil Eleveld target-controlled infusion. During general anesthesia, a 30-second electrical stimulus was given as surrogate for surgical incision to the volunteers at each dosage step. Blood samples were drawn before the initial dosing and after each dosing step, and plasma NE, propofol and remifentanil concentrations were subsequently determined. A population PK model was developed using non-linear mixed effects modelling. Simulations were conducted to predict the plasma NE concentration in patients at different measured propofol concentrations. Results A total of 1219 samples were analyzed from 36 volunteers. A two-compartment model with a first-order elimination best described the data. Weight, age, and session effect (awake vs general anesthesia) were identified as relevant covariates on the clearance (CL) of NE. A 10% decrease in NE CL was observed after general anesthesia induction. This difference between sessions is better explained by the measured concentration of propofol, rather than the anticipated impact of cardiac output. The estimated post-stimulation NE concentration is 0.66 nmol/L –1 (95% CI 0.06–1.20 nmol/L –1 ) lower than the pre-stimulation NE concentration. Model simulation indicates that patients at a higher measured propofol concentration (e.g., 6 mcg/mL –1 ) exhibited higher NE concentrations (95% PI 18.10–43.89 nmol/L –1 ) than patients at a lower measured propofol concentration (e.g., 3 mcg/mL –1 ) (95% PI 16.81–38.91 nmol L –1 ). Conclusion The NE PK is well described with a two-compartment model with a first-order elimination. NE CL exhibiting a 10% decrease under general anesthesia, with this difference being attributed to the measured concentration of propofol. The impact of stimulation on NE PK under general anesthesia is very limited. Clinical Trials Registration Number NL9312.

Propofol infusion syndrome (PRIS) is a rare, severe complication from prolonged high-dose propofol use. Predictive biomarkers, especially in spinal surgery, remain unclear. This study aimed to biochemically and pharmacologically characterize risk markers of PRIS following high-dose propofol infusion in patients undergoing elective spinal surgery. A quasi-experimental interventional study was conducted in 2024 at Allameh Bohlool Gonabadi Hospital. Fifty-four patients aged 20–70 years scheduled for elective spinal surgery and classified as ASA physical status I or II were enrolled via convenience sampling. Baseline blood samples were collected one day prior to surgery. Propofol maintenance anesthesia were performed using standardized dosages, including continuous intravenous infusion at 10 mg/kg/h. A second blood sample was taken four hours after propofol infusion initiation. Biochemical parameters assessed included triglycerides, HDL, LDL, total cholesterol, arterial blood pH, bicarbonate ion (HCO3−), and base excess (BE). Data analysis employed paired t-tests and Pearson correlation coefficients with significance set at p < 0.05. Serum triglyceride levels increased significantly postoperatively from a mean of 153.07 mg/dL to 214.30 mg/dL (p < 0.001, CI = (− 1.19,− 0.57)). Other biochemical markers showed no statistically significant changes. Additionally, surgical duration correlated with changes in bicarbonate levels and lipid profiles. High-dose propofol infusion during elective spinal surgery was associated with a significant increase in serum triglycerides, emphasizing the potential risk of PRIS. These results underscore the importance of perioperative monitoring of lipid profiles in patients receiving high doses of propofol to enable early detection and timely intervention. A notable limitation of our study was the lack of a control group.

The optimal sedation strategy for gastrointestinal endoscopy remains debated. This study compared the efficacy and safety of remimazolam combined with etomidate versus propofol for procedural sedation during gastrointestinal endoscopy. This single-center, randomized controlled clinical trial was performed from March 2024 to April 2024. A total of 262 patients scheduled to undergo gastrointestinal endoscopy were randomly assigned to receive remimazolam-etomidate (RE) or remimazolam-propofol (RP). The primary outcome was the incidence of respiratory depression. Secondary outcomes included the results of sedation and recovery. The safety results mainly include the incidence of hypotension, bradycardia, tachycardia, painful injection and muscular tremor. Statistical analyses included t-tests, Mann-Whitney U tests, and χ² tests for group comparisons, with subgroup analyses and multivariable logistic regression to assess the robustness of primary outcome. Respiratory depression occurred in 20.0% (25/125) of RE patients versus 32.3% (40/124) of RP patients (OR=0.52; 95% CI = 0.29-0.93; p = 0.028). There was a statistically significant difference in the distribution of the number of airway interventions between the two groups (p = 0.043), with 18 patients (14.5%) in the RP group requiring three airway interventions and only seven patients (5.6%) in the RE group. Hypoxemia occurred in three patients (2.4%) in the RE group and in five patients (4.0%) in the RP group. Hypotension was observed in 23.2% of patients sedated with RE versus 36.3% of patients sedated with RP (p = 0.024). Remimazolam-etomidate demonstrated a superior safety profile, with reduced respiratory depression and hemodynamic instability compared to remimazolam-propofol, suggesting its potential as a safer alternative for gastrointestinal endoscopy sedation. This trial was prospectively registered at the Chinese Clinical Trial Registry (ChiCTR2400085904) prior to patient enrollment.

Background Remimazolam besylate is a newer benzodiazepine with characteristics of quick onset of effects, short maintenance and recovery times without accumulation in tissues. This trial was conducted to confirm the efficacy and safety of remimazolam besylate versus propofol during hysteroscopy. Methods Patients undergoing hysteroscopy were randomly assigned to either the remimazolam (Group R) or the propofol group (Group P). Group R was administered an induction dose of 0.2 mg/kg and a maintenance dosage of 1.0 mg/kg/h. In Group P, propofol was started at 1.5–2.0 mg/kg and then maintained at 3.0–6.0 mg/kg/h. After remimazolam besylate or propofol induction, remifentanil was infused using a target-controlled infusion system with a target concentration of 1.5 ng/ml and titrated during the procedure. The incidence rates of injection pain, low oxygen saturation (SpO 2 ) and adverse effects in both groups were compared. Results Eighty-two patients were included in this study. The incidence of adverse events in Group R (3.7%) was significantly lower than that in Group P (36.6%) ( p  < 0.001). The incidence of injection pain in Group P (80.5%) was much higher than that in Group R (2.4%) ( p  < 0.001). The incidence of other adverse events, such as low SpO 2 , bradycardia, and hypotension in Group R was lower than that in Group P ( p  < 0.05). Conclusions Remimazolam besylate proves to be a safer alternative for anesthesia during hysteroscopy. Moreover, adverse events caused by propofol, such as low SpO 2 and injection pain, are largely avoided. Trial registration This study was approved by the Clinical Research Ethics Committee of Mengcheng County No. 1 People’s Hospital (2020MYL20003) and registered at http://www.chictr.org.cn (15/09/2020, ChiCTR-2000038252 ). The study protocol followed the CONSORT guidelines. The study protocol was performed in the relevant guidelines.

Objective To compare the efficacy and safety of remimazolam besylate and propofol for deep sedation in critically ill patients. Methods In this single-center, prospective, randomized, controlled pilot study, patients in the intensive care unit (ICU) requiring deep sedation were randomized to receive remimazolam besylate or propofol intravenously. Deep sedation was defined as a Richmond Agitation and Sedation Scale (RASS) score of − 4 or − 5. Sedation depth was monitored using RASS and Narcotrend Index (NI). The primary outcome was the percentage of time within the target sedation range without rescue sedation. The secondary outcomes included ventilator-free hours within 7 days, successful extubation, length of ICU stay, and 28-day mortality. Adverse events during the interventional period were also recorded. Results Thirty patients were assigned to each group. The median (IQR) RASS score was − 5.0 (− 5.0, − 4.0), and the median (IQR) NI value was 29.0 (21.0, 37.0) during the intervention period. Target RASS was reached a median of 100% of the sedation time in the two groups. No significant differences were observed in ventilator-free hours within 7 days, successful extubation, length of ICU stay, or 28-day mortality among groups. Hypotension occurred in 16 (53.3%) patients of remimazolam group and 18 (60.0%) patients of propofol group ( p  > 0.05). No patient experienced bradycardia. Conclusions Remimazolam besylate appears to be an effective and safe agent for short-term deep sedation in critically ill patients. Our findings warrant large sample-sized randomized clinical trials.