New sedatives and analgesic drugs for gastrointestinal endoscopic procedures

Lee, Jae Min; Park, Yehyun; Park, Jin Myung; Park, Hong Jun; Bae, Jun Yong; Seo, Seung Young; Lee, Jee Hyun; Chon, Hyung Ku; Chung, Jun‐Won; Choi, Hyun Ho; Kim, Byung‐Wook

doi:10.5946/ce.2021.283

Cited by 11 publications

(7 citation statements)

References 37 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Our study developed the pediatric PBPK/PD model of midazolam rectal gel for predicting pediatric sedation dose. Procedural sedation has become common in therapeutic endoscopy or surgery for the pediatric population . An appropriate level of sedation is necessary for the pediatric population due to the growth and development at different ages .…”

Section: Discussionmentioning

confidence: 99%

“…Procedural sedation has become common in therapeutic endoscopy or surgery for the pediatric population. 67 An appropriate level of sedation is necessary for the pediatric population due to the growth and development at different ages. 68 Kuemmel et al applied the Credibility Assessment Framework from the American Society of Mechanical Engineers (ASME) to evaluate the credibility of PBPK modeling and simulations in drug development.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Characterization of Pediatric Rectal Absorption, Drug Disposition, and Sedation Level for Midazolam Gel Using Physiologically Based Pharmacokinetic/Pharmacodynamic Modeling

Zhu,

Zhou,

Wang

et al. 2024

Mol. Pharmaceutics

View full text Add to dashboard Cite

This study aims to explore and characterize the role of pediatric sedation via rectal route. A pediatric physiologically based pharmacokineticpharmacodynamic (PBPK/PD) model of midazolam gel was built and validated to support dose selection for pediatric clinical trials. Before developing the rectal PBPK model, an intravenous PBPK model was developed to determine drug disposition, specifically by describing the ontogeny model of the metabolic enzyme. Pediatric rectal absorption was developed based on the rectal PBPK model of adults. The improved Weibull function with permeability, surface area, and fluid volume parameters was used to extrapolate pediatric rectal absorption. A logistic regression model was used to characterize the relationship between the free concentrations of midazolam and the probability of sedation. All models successfully described the PK profiles with absolute average fold error (AAFE) < 2, especially our intravenous PBPK model that extended the predicted age to preterm. The simulation results of the PD model showed that when the free concentrations of midazolam ranged from 3.9 to 18.4 ng/mL, the probability of "Sedation" was greater than that of "Not-sedation" states. Combined with the rectal PBPK model, the recommended sedation doses were in the ranges of 0.44−2.08 mg/kg for children aged 2−3 years, 0.35−1.65 mg/kg for children aged 4−7 years, 0.24−1.27 mg/kg for children aged 8−12 years, and 0.20−1.10 mg/kg for adolescents aged 13−18 years. Overall, this model mechanistically quantified drug disposition and effect of midazolam gel in the pediatric population, accurately predicted the observed clinical data, and simulated the drug exposure for sedation that will inform dose selection for following pediatric clinical trials.

show abstract

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Characterization of Pediatric Rectal Absorption, Drug Disposition, and Sedation Level for Midazolam Gel Using Physiologically Based Pharmacokinetic/Pharmacodynamic Modeling

Zhu,

Zhou,

Wang

et al. 2024

Mol. Pharmaceutics

View full text Add to dashboard Cite

show abstract

“…However, ketamine adverse events were noticed in this group and should be considered in the evaluation of the overall effectiveness [ 80 ]. The choice of sedative should be tailored to the individual patient and the specific procedure being performed [ 81 – 83 ]. It is worth mentioning that the use of sedation should always be performed by a trained professional, and the use of monitoring devices should be considered to ensure patient safety [ 84 , 85 ].…”

Section: Methodsmentioning

confidence: 99%

Up-to-date literature review and issues of sedation during digestive endoscopy.

Liu¹,

Zhang²

2023

Videosurgery and Other Miniinvasive Techniques

View full text Add to dashboard Cite

Sedation is common during digestive endoscopy to provide comfort and pain relief for patients. However, the use of sedation in endoscopy also poses potential risks, and recent issues have been raised regarding its safety and administration. This literature review paper will discuss the most recent developments in the field of sedation in digestive endoscopy, including the adverse events that might be associated with sedation and how to manage it, the legal issues associated with administration, the impact of COVID-19 on sedation practices, and sedation in special situations. It will also touch upon the current guidelines and recommendations for sedation, including the importance of patient selection and monitoring and the need for training and certification for endoscopists administering sedation. The review will also analyse studies evaluating the safety and efficacy of various sedation techniques, including propofol, midazolam, and others. It will examine the benefits and drawbacks of these agents.

show abstract

“…7 Shutai is an analgesic and sedative agent of recent pharmacological development, finds application in endoscopic procedures. 8 Although the effectiveness of this technique in improving patient comfort is recognized, little is known about its effects on wound healing and the occurrence of complications following the procedure. 9 Streptomyces protease enzyme is chosen for its potential in facilitating smoother tissue interaction and faster wound healing, which is crucial in gastroscopic procedures.…”

Section: Introductionmentioning

confidence: 99%

“…Shutai is an analgesic and sedative agent of recent pharmacological development, finds application in endoscopic procedures. 8 Although the effectiveness of this technique in improving patient comfort is recognized, little is known about its effects on wound healing and the occurrence of complications following the procedure. 9 …”

Section: Introductionmentioning

confidence: 99%

Assessing wound complications in gastroscopy with Streptomyces protease enzyme combined with Shutai

Chen,

Li,

Zhou

et al. 2024

International Wound Journal

View full text Add to dashboard Cite

Current gastroscopy practices necessitate a balance between procedural efficiency and patient safety. It has been hypothesized that increasing procedure outcomes through the use of Streptomyces protease enzyme and Shutai is possible; however, precise nature of any potential adverse reactions and complications remains unknown. In Zhanjiang, China, 213 patients undergoing gastroscopy participated in this controlled trial. The subjects were allocated at random into two groups: control and treatment. The treatment group was administered topical Streptomyces protease enzyme and intravenous Shutai. Using chi‐square and t‐tests, information regarding patient demographics, adverse reactions, wound healing, procedure duration, distress levels, and satisfaction was gathered and analysed. The demographic and medical history characteristics of the groups were comparable. There was a greater prevalence of modest immediate reactions in the treatment group (p < 0.05), whereas there were no significant variations observed in delayed reactions and long‐term complications (p > 0.05). The treatment group exhibited superior efficiency metrics, including shorter durations for diagnosis, procedure completion and recuperation (p < 0.05). The treatment group exhibited significantly higher patient satisfaction scores (p < 0.05). The incorporation of Streptomyces protease enzyme and Shutai into gastroscopy procedures resulted in significantly enhanced level of procedural efficacy and patient contentment while not introducing an additional risk of long‐term complications. The increase in moderate immediate reactions that have been observed requires additional research in order to determine their clinical significance. Although these agents present a possible progression in the field of gastroscopy, their application should be tempered by the immediate adverse reactions that have been documented.

show abstract

New sedatives and analgesic drugs for gastrointestinal endoscopic procedures

Cited by 11 publications

References 37 publications

Characterization of Pediatric Rectal Absorption, Drug Disposition, and Sedation Level for Midazolam Gel Using Physiologically Based Pharmacokinetic/Pharmacodynamic Modeling

Characterization of Pediatric Rectal Absorption, Drug Disposition, and Sedation Level for Midazolam Gel Using Physiologically Based Pharmacokinetic/Pharmacodynamic Modeling

Up-to-date literature review and issues of sedation during digestive endoscopy.

Assessing wound complications in gastroscopy with Streptomyces protease enzyme combined with Shutai

Contact Info

Product

Resources

About