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...

Descripción completa

Detalles Bibliográficos
Autores principales: Ni, Wenwen, Yi, Xiuwen, Feng, Lili, Shen, Yilei, Jiao, Jiali, Cai, Yirong, Fu, Danyun, Han, Yuan, Jia, Ji’e, Li, Wenxian
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