Pharmacokinetics and the pharmacodynamic action of midazolam in young and elderly patients undergoing tooth extraction*

Platten, Hans-Peter; Schweizer, Eberhard; Dilger, Karin; Mikus, Gerd; Klotz, Ulrich

doi:10.1016/s0009-9236(98)90106-0

Cited by 83 publications

(42 citation statements)

References 46 publications

(16 reference statements)

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“…The same results were obtained with regards to gender (P>0.05). These data suggest that midazolam pharmacokinetics in Chinese after oral administration are unaffected by either age or gender, and this conclusion is consistent with studies of Caucasian subjects [34][35][36][37] . As an oral hypnotic, midazolam has been in the market for many years in China; however, there have been few pharmacokinetic studies [25][26][27] , and there is significant inter-study variability (Table 5).…”

Section: Midazolam Pharmacokinetics In Chinese After Oral Adminis Trasupporting

confidence: 88%

“…Investigation of the effects on midazolam pharmacokinetics using the PBPK model Previous studies in Caucasians demonstrated that the pharmacokinetics of midazolam were unaffected by age [34][35][36][37] ; however, this topic has never been examined in Chinese. In this study, the verified PBPK model was used to investigate the effects of age on midazolam pharmacokinetics in Chinese from a physiological perspective.…”

Section: Midazolam Pbpk Modelingmentioning

confidence: 99%

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Evaluating a physiologically based pharmacokinetic model for predicting the pharmacokinetics of midazolam in Chinese after oral administration

et al. 2015

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Aim: To evaluate the SimCYP simulator ethnicity-specific population model for predicting the pharmacokinetics of midazolam, a typical CYP3A4/5 substrate, in Chinese after oral administration. Methods: The physiologically based pharmacokinetic (PBPK) model for midazolam was developed using a SimCYP population-based simulator incorporating Chinese population demographic, physiological and enzyme data. A clinical trial was conducted in 40 Chinese subjects (the half was females) receiving a single oral dose of 15 mg midazolam. The subjects were separated into 4 groups based on age (20-50, 51-65, 66-75, and above 76 years), and the pharmacokinetics profiles of each age-and gender-group were determined, and the results were used to verify the PBPK model. Results: Following oral administration, the simulated profiles of midazolam plasma concentrations over time in virtual Chinese were in good agreement with the observed profiles, as were AUC and C max . Moreover, for subjects of varying ages (20-80 years), the ratios of predicted to observed clearances were between 0.86 and 1.12. Conclusion: The SimCYP PBPK model accurately predicted the pharmacokinetics of midazolam in Chinese from youth to old age. This study may provide novel insight into the prediction of CYP3A4/5-mediated pharmacokinetics in the Chinese population relative to Caucasians and other ethnic groups, which can support the rational design of bridging clinical trials.

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Section: Midazolam Pharmacokinetics In Chinese After Oral Adminis Trasupporting

confidence: 88%

Section: Midazolam Pbpk Modelingmentioning

confidence: 99%

Evaluating a physiologically based pharmacokinetic model for predicting the pharmacokinetics of midazolam in Chinese after oral administration

et al. 2015

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“…observée dans d'autres études cliniques [27], puis en chirurgie orale [28], mais il n'y a pas eu d'analyses complémentaires. Ainsi l'administration de midazolam doit être guidée par l'effet pharmacologique, et non pas par un schéma posologique strictement basé sur le poids.…”

Section: Variabilité Interindividuelleunclassified

“…D'autres études [28,36,[45][46][47] ont évalué la variation de la saturation en oxygène dans le cadre du suivi des constantes vitales. Elles confirment le fait que si l'on observe une diminution de la saturation en oxygène après l'administration, elle est cependant de courte durée et sans conséquence clinique.…”

Section: Effets Sur Les Fonctions Autonomesunclassified

Le midazolam. 1^repartie : pharmacologie

Descroix

André²,

Pong

2012

Med Buccale Chir Buccale

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Résumé -Les benzodiazépines constituent une classe de médicaments qui regroupent un nombre important de molécules ayant des propriétés pharmacologiques communes (anxiolytiques, sédatives, hypnotiques, amnésiques, myorelaxantes et anticonvulsivantes). Il s'agit pour la plupart de molécules hautement lipophiles dont les indications thérapeutiques sont larges, allant de l'anxiolyse à l'anesthésiologie. Le midazolam, de part ses propriétés physicochimiques singulières, se démarque des autres benzodiazépines et représente à ce titre la molécule la plus étudiée et la plus utilisée en anesthésiologie, notamment pour la sédation quelle qu'en soit la profondeur. Avant d'envisager ses indications et son utilisation pour la sédation consciente en chirurgie orale, il convient de préciser ses différentes caractéristiques pharmacologiques. Abstract -Midazolam. Part I: Pharmacology.Benzodiazepines are a class of drugs that include a large number of molecules with common pharmacological properties (anxiolytic, sedative, hypnotic, amnesic, anticonvulsant and muscle-relaxing). They are mostly highly lipophilic molecules which therapeutic indications are broad, ranging from anxiolysis to anesthesia. Midazolam, because of its unique physicochemical properties, is different from other benzodiazepines and thus represents the molecule most studied and most widely used in anaesthesia, including sedation regardless of depth. Before considering its indications and its use for conscious sedation in oral surgery, it should clarify its different pharmacological characteristics.

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“…Such factors include advanced age, hepatic or renal disease, cigarette smoking, chronic benzodiazepine administration, and coadministration of ethanol or other centrally acting compounds. [10][11][12] Therefore, our aim was to clarify the relevance of pharmacokinetic and pharmacodynamic factors to cognitive impairment after gastrointestinal endoscopy under diazepam.…”

Section: Introductionmentioning

confidence: 99%

Impairment State of Cognitive Performance and the Affecting Factors in Outpatients Following Gastrointestinal Endoscopy after Single-dose Diazepam

et al. 2005

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Diazepam is commonly used as premedicant for endoscopic procedures. Wide interindividual diŠerences have been observed in the residual cognitive eŠects of the drug after gastrointestinal endoscopy. Our aim was to clarify the major factors, including pharmacokinetic factors, contributing to this wide variation in residual cognitive eŠect after gastrointestinal endoscopy in the study. Sixty-one outpatients undergoing gastrointestinal endoscopy participated in the study. Cognitive eŠects were evaluated in the diazepam group (n＝52) by the digit symbol substitution test (DSST) twice before and 30 min after an intravenous administration of 5 mg diazepam; in the intervening time gastrointestinal endoscopy was performed. Plasma concentrations of diazepam were determined by HPLC. The control group (n＝9) was tested by DSST in the same manner. The cognitive eŠects according to the change in DSST score was signiˆcantly decline in the diazepam group compared with the control group (by 0.2 versus -4.6; P＝0.014). This prospective study conrmed that cognition was signiˆcantly impaired after gastrointestinal endoscopy by premedication to subjects with 5 mg diazepam. There were very wide variations in change in DSST score. However we could not identify the independent variables that best predicted DSST score diŠerence in a multiple regression analysis for age, plasma albumin level, and plasma diazepam concentration 30 min after intravenous administration. We should pay attention to patients' individual states in cognitive performance following gastrointestinal endoscopy after single-dose diazepam.

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Pharmacokinetics and the pharmacodynamic action of midazolam in young and elderly patients undergoing tooth extraction*

Cited by 83 publications

References 46 publications

Evaluating a physiologically based pharmacokinetic model for predicting the pharmacokinetics of midazolam in Chinese after oral administration

Evaluating a physiologically based pharmacokinetic model for predicting the pharmacokinetics of midazolam in Chinese after oral administration

Le midazolam. 1^repartie : pharmacologie

Impairment State of Cognitive Performance and the Affecting Factors in Outpatients Following Gastrointestinal Endoscopy after Single-dose Diazepam

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Pharmacokinetics and the pharmacodynamic action of midazolam in young and elderly patients undergoing tooth extraction*

Cited by 83 publications

References 46 publications

Evaluating a physiologically based pharmacokinetic model for predicting the pharmacokinetics of midazolam in Chinese after oral administration

Evaluating a physiologically based pharmacokinetic model for predicting the pharmacokinetics of midazolam in Chinese after oral administration

Le midazolam. 1repartie : pharmacologie

Impairment State of Cognitive Performance and the Affecting Factors in Outpatients Following Gastrointestinal Endoscopy after Single-dose Diazepam

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Le midazolam. 1^repartie : pharmacologie