Cargando…
Comparison of different weight-based scalars of remimazolam tosylate for anesthesia induction in obese patients: study protocol for a prospective, controlled trial
BACKGROUND: The physiologic and anthropometric characteristics changes associated with obesity may result in the alternation of pharmacologic management. Remimazolam tosylate is a new type of ultra-short-acting benzodiazepine with stable context-sensitive half-time (CSHT) and no lipid accumulation a...
Autores principales: | , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2023
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10638826/ https://www.ncbi.nlm.nih.gov/pubmed/37950290 http://dx.doi.org/10.1186/s13063-023-07739-6 |
_version_ | 1785133680773038080 |
---|---|
author | Ni, Wenwen Yi, Xiuwen Feng, Lili Shen, Yilei Jiao, Jiali Cai, Yirong Fu, Danyun Han, Yuan Jia, Ji’e Li, Wenxian |
author_facet | Ni, Wenwen Yi, Xiuwen Feng, Lili Shen, Yilei Jiao, Jiali Cai, Yirong Fu, Danyun Han, Yuan Jia, Ji’e Li, Wenxian |
author_sort | Ni, Wenwen |
collection | PubMed |
description | BACKGROUND: The physiologic and anthropometric characteristics changes associated with obesity may result in the alternation of pharmacologic management. Remimazolam tosylate is a new type of ultra-short-acting benzodiazepine with stable context-sensitive half-time (CSHT) and no lipid accumulation after long-time infusion. Although remimazolam tosylate has potential advantages for the induction and maintenance of anesthesia in obese patients, the appropriate induction dosing scalars among obese patients are unknown. Therefore, we aim to compare the different weight-based scalars for dosing remimazolam tosylate of anesthesia induction among obese patients. METHODS/DESIGN: The study will be performed as a prospective, single-center, double-blind, controlled clinical trial. The study design is a comparison of remimazolam tosylate requirements based on total body weight (TBW) or lean body weight (LBW) to reach a Modified Observer’s Assessment of Alertness and Sedation (MOAA/S) score of 0 among obese subjects (BMI ≥ 35 kg/m(2)). Another twenty normal-weight subjects (18.5 kg/m(2) ≤ BMI < 25 kg/m(2)) will be enrolled as a control group, whose induction dose is scaled based on TBW. The infusion rate of remimazolam tosylate during induction is 12 mg/kg/h in all groups. DISCUSSION: Results of the present study will provide evidence of dose scalar of remimazolam tosylate to guide the clinical practice of anesthesia induction in obese patients. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR220005664. Registered on 9 February 2022, https://www.chictr.org.cn/showproj.aspx?proj=151150. |
format | Online Article Text |
id | pubmed-10638826 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-106388262023-11-11 Comparison of different weight-based scalars of remimazolam tosylate for anesthesia induction in obese patients: study protocol for a prospective, controlled trial Ni, Wenwen Yi, Xiuwen Feng, Lili Shen, Yilei Jiao, Jiali Cai, Yirong Fu, Danyun Han, Yuan Jia, Ji’e Li, Wenxian Trials Study Protocol BACKGROUND: The physiologic and anthropometric characteristics changes associated with obesity may result in the alternation of pharmacologic management. Remimazolam tosylate is a new type of ultra-short-acting benzodiazepine with stable context-sensitive half-time (CSHT) and no lipid accumulation after long-time infusion. Although remimazolam tosylate has potential advantages for the induction and maintenance of anesthesia in obese patients, the appropriate induction dosing scalars among obese patients are unknown. Therefore, we aim to compare the different weight-based scalars for dosing remimazolam tosylate of anesthesia induction among obese patients. METHODS/DESIGN: The study will be performed as a prospective, single-center, double-blind, controlled clinical trial. The study design is a comparison of remimazolam tosylate requirements based on total body weight (TBW) or lean body weight (LBW) to reach a Modified Observer’s Assessment of Alertness and Sedation (MOAA/S) score of 0 among obese subjects (BMI ≥ 35 kg/m(2)). Another twenty normal-weight subjects (18.5 kg/m(2) ≤ BMI < 25 kg/m(2)) will be enrolled as a control group, whose induction dose is scaled based on TBW. The infusion rate of remimazolam tosylate during induction is 12 mg/kg/h in all groups. DISCUSSION: Results of the present study will provide evidence of dose scalar of remimazolam tosylate to guide the clinical practice of anesthesia induction in obese patients. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR220005664. Registered on 9 February 2022, https://www.chictr.org.cn/showproj.aspx?proj=151150. BioMed Central 2023-11-10 /pmc/articles/PMC10638826/ /pubmed/37950290 http://dx.doi.org/10.1186/s13063-023-07739-6 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Study Protocol Ni, Wenwen Yi, Xiuwen Feng, Lili Shen, Yilei Jiao, Jiali Cai, Yirong Fu, Danyun Han, Yuan Jia, Ji’e Li, Wenxian Comparison of different weight-based scalars of remimazolam tosylate for anesthesia induction in obese patients: study protocol for a prospective, controlled trial |
title | Comparison of different weight-based scalars of remimazolam tosylate for anesthesia induction in obese patients: study protocol for a prospective, controlled trial |
title_full | Comparison of different weight-based scalars of remimazolam tosylate for anesthesia induction in obese patients: study protocol for a prospective, controlled trial |
title_fullStr | Comparison of different weight-based scalars of remimazolam tosylate for anesthesia induction in obese patients: study protocol for a prospective, controlled trial |
title_full_unstemmed | Comparison of different weight-based scalars of remimazolam tosylate for anesthesia induction in obese patients: study protocol for a prospective, controlled trial |
title_short | Comparison of different weight-based scalars of remimazolam tosylate for anesthesia induction in obese patients: study protocol for a prospective, controlled trial |
title_sort | comparison of different weight-based scalars of remimazolam tosylate for anesthesia induction in obese patients: study protocol for a prospective, controlled trial |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10638826/ https://www.ncbi.nlm.nih.gov/pubmed/37950290 http://dx.doi.org/10.1186/s13063-023-07739-6 |
work_keys_str_mv | AT niwenwen comparisonofdifferentweightbasedscalarsofremimazolamtosylateforanesthesiainductioninobesepatientsstudyprotocolforaprospectivecontrolledtrial AT yixiuwen comparisonofdifferentweightbasedscalarsofremimazolamtosylateforanesthesiainductioninobesepatientsstudyprotocolforaprospectivecontrolledtrial AT fenglili comparisonofdifferentweightbasedscalarsofremimazolamtosylateforanesthesiainductioninobesepatientsstudyprotocolforaprospectivecontrolledtrial AT shenyilei comparisonofdifferentweightbasedscalarsofremimazolamtosylateforanesthesiainductioninobesepatientsstudyprotocolforaprospectivecontrolledtrial AT jiaojiali comparisonofdifferentweightbasedscalarsofremimazolamtosylateforanesthesiainductioninobesepatientsstudyprotocolforaprospectivecontrolledtrial AT caiyirong comparisonofdifferentweightbasedscalarsofremimazolamtosylateforanesthesiainductioninobesepatientsstudyprotocolforaprospectivecontrolledtrial AT fudanyun comparisonofdifferentweightbasedscalarsofremimazolamtosylateforanesthesiainductioninobesepatientsstudyprotocolforaprospectivecontrolledtrial AT hanyuan comparisonofdifferentweightbasedscalarsofremimazolamtosylateforanesthesiainductioninobesepatientsstudyprotocolforaprospectivecontrolledtrial AT jiajie comparisonofdifferentweightbasedscalarsofremimazolamtosylateforanesthesiainductioninobesepatientsstudyprotocolforaprospectivecontrolledtrial AT liwenxian comparisonofdifferentweightbasedscalarsofremimazolamtosylateforanesthesiainductioninobesepatientsstudyprotocolforaprospectivecontrolledtrial |