Determination of the 95% effective dose of remimazolam tosylate in anesthesia induction inhibits endotracheal intubation response in senile patients

Qu, Liangchao; Liu, Mei; Ouyang, Ru; Li, Tianyuan; Long, Dingde; Jiang, Yanfen; Wang, Chengyu; Cheng, Liqin

doi:10.3389/fphar.2023.1136003

Cited by 4 publications

(1 citation statement)

References 41 publications

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“…According to sample size termination criteria of the biased-coin sequential allocation method, literature and preliminary experiment research studies implied that using 20 to 40 patients would yield stable estimates of the target estimate of ED50 and ED90 [ 7 , 14 – 16 , 18 , 19 ]. The purpose of this study is to observe the ED50 of epidural morphine and hydromorphone analgesia in patients undergoing hemorrhoidectomy.…”

Section: Methodsmentioning

confidence: 99%

The 50% effective dose of hydromorphone and morphine for epidural analgesia in the hemorrhoidectomy: a double-blind, sequential dose-finding study

Cao,

Gui,

Wei

et al. 2024

BMC Anesthesiol

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Background Although previous studies have showed that epidural morphine can be used as a complement to local anesthetics for analgesia after postcesarean delivery under spinal anesthesia, there is little known about the analgesic dosage of epidural morphine and hydromorphone for hemorrhoidectomy. Therefore, we conducted this study to examine the potency ratio of hydromorphone to epidural morphine as well as effective analgesic dose for 50% patients (ED50) undergoing elective hemorrhoidectomy. Methods 80 patients under elective hemorrhoidectomy with combined spinal and epidural anesthesia(CSEA) in department of anesthesia, Dongguan Tungwah hospital. To assess the ED50, patients were treated with epidural morphine or epidural hydromorphone randomly using a biased coin method-determined dose with a sequential allocation procedure. Following surgery, standardized multimodal analgesia was administered to all patients. A pain response score of ≤ 3 (on a scale of 0–10) was determined to be the effective dose after 24 h following CSEA. The ED50 in both groups were determined using the probit regression and isotonic regression method. We also measured pain intensity by patient interview using a 10 point verbal numeric rating scale prospectively at 6, 12 and 24 h after CSEA, and adverse effects were also noted. Results The ED50 was 0.350 mg (95% CI, 0.259–0.376 mg) in hydromorphone group and 1.129 mg (95% CI, 0.903–1.187 mg) in morphine group, respectively, estimated by isotonic regression method. Regression analysis with the probit, the ED50 of epidural hydromorphone was 0.366 mg (95% CI, 0.276–0.388 mg) and epidural morphine was 1.138 mg (95% CI, 0.910–1.201 mg). Exploratory findings showed that there was no difference between the most frequent dosages of epidural hydromorphone or epidural morphine in the occurrence of nausea, vomiting and pruritus. When administered with epidural opioids at ED50 doses or higher, 97.5% (39/40) of epidural morphine patients and 97.5% (39/40) epidural hydromorphone of patients were satisfied with their analgesia. Conclusion Effective hemorrhoidectomy analgesia requires a 3:1 ratio of epidural morphine to epidural hydromorphone. Both drugs provide excellent patient satisfaction.

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Section: Methodsmentioning

confidence: 99%

The 50% effective dose of hydromorphone and morphine for epidural analgesia in the hemorrhoidectomy: a double-blind, sequential dose-finding study

Cao,

Gui,

Wei

et al. 2024

BMC Anesthesiol

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Reparametrized Firth's Logistic Regressions for Dose‐Finding Study With the Biased‐Coin Design

Kim,

Jung,

Pawitan

et al. 2024

Pharmaceutical Statistics

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Finding an adequate dose of the drug by revealing the dose–response relationship is very crucial and a challenging problem in the clinical development. The main concerns in dose‐finding study are to identify a minimum effective dose (MED) in anesthesia studies and maximum tolerated dose (MTD) in oncology clinical trials. For the estimation of MED and MTD, we propose two modifications of Firth's logistic regression using reparametrization, called reparametrized Firth's logistic regression (rFLR) and ridge‐penalized reparametrized Firth's logistic regression (RrFLR). The proposed methods are designed by directly reducing the small‐sample bias of the maximum likelihood estimate for the parameter of interest. In addition, we develop a method on how to construct confidence intervals for rFLR and RrFLR using profile penalized likelihood. In the up‐and‐down biased‐coin design, numerical studies confirm the superior performance of the proposed methods in terms of the mean squared error, bias, and coverage accuracy of confidence intervals.

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Impact of remimazolam on postoperative inflammatory markers and complications in thoracoscopic pulmonary lobectomy patients: A retrospective analysis

Chen,

Shi,

Shi

2024

Medicine

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Remazolam is widely used for procedural sedation in intensive care units. It has been shown to have anti-inflammatory and organ-protecting properties. However, the changes in inflammatory markers and analgesic effects of remazolam after thoracoscopic pulmonary lobectomy remain unclear. This study aims to assess the effects of the novel drug remimazolam on inflammatory factor levels and postoperative complications in thoracoscopic pulmonary lobectomy patients, providing a scientific basis for clinical use. This retrospective study analyzed 200 thoracoscopic pulmonary lobectomy patients, who were divided into a control group and a remimazolam group based on their anesthesia method. Patients in ramazolam group were anesthetized with ramazolam, while patients in control group were anesthetized with propofol. All patients were performed by the same physician team and anesthesia team. Inflammatory factors (including interleukin-6 [IL-6], C-reactive protein [CRP], including interleukin-8) were measured preoperatively and postoperatively, and postoperative complication rates were compared between the 2 groups. The levels of IL-6 and CRP were significantly higher in the remimazolam group at 7 days postoperatively compared to the control group. No significant differences were observed in preoperative inflammatory factors or postoperative including interleukin-8 levels between the 2 groups. Additionally, there were no significant differences in the overall incidence of postoperative complications or in specific complications such as pulmonary infection, atelectasis, subcutaneous emphysema, pneumothorax, surgical site infection, and arrhythmia. Patients receiving remimazolam had higher postoperative IL-6 and CRP levels compared to the control group, without an increase in postoperative complications. In clinical use, attention should be paid to the control of inflammatory indicators in patients using remazolam. However, due to potential confounding factors and the retrospective design, we cannot establish a causal relationship between remimazolam and elevated inflammatory markers. These findings suggest a possible association that requires cautious interpretation. Further research is needed to assess the clinical relevance and explore the underlying mechanisms.

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Determination of the 95% effective dose of remimazolam tosylate in anesthesia induction inhibits endotracheal intubation response in senile patients

Cited by 4 publications

References 41 publications

The 50% effective dose of hydromorphone and morphine for epidural analgesia in the hemorrhoidectomy: a double-blind, sequential dose-finding study

The 50% effective dose of hydromorphone and morphine for epidural analgesia in the hemorrhoidectomy: a double-blind, sequential dose-finding study

Reparametrized Firth's Logistic Regressions for Dose‐Finding Study With the Biased‐Coin Design

Impact of remimazolam on postoperative inflammatory markers and complications in thoracoscopic pulmonary lobectomy patients: A retrospective analysis

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