Cargando…

The safety and efficacy of esketamine in comparison to dexmedetomidine during drug-induced sleep endoscopy in children with obstructive sleep apnea hypopnea syndrome: A randomized, controlled and prospective clinical trial

Background and Purpose: Data and high-quality studies of anesthetic methods for children with obstructive sleep apnea hypopnea syndrome (OSAHS) who undergo drug-induced sleep endoscopy (DISE) are limited. Research on pediatric DISE using esketamine has never been reported before. To test the safety...

Descripción completa

Detalles Bibliográficos
Autores principales: Yongping, Zheng, Xinyi, Li, Aming, Sang, Qiang, Xie, Tianqi, Zhou, Mengmeng, Shen, Xiong, Chen, Xuemin, Song
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9751969/
https://www.ncbi.nlm.nih.gov/pubmed/36532775
http://dx.doi.org/10.3389/fphar.2022.1036509
_version_ 1784850603365629952
author Yongping, Zheng
Xinyi, Li
Aming, Sang
Qiang, Xie
Tianqi, Zhou
Mengmeng, Shen
Xiong, Chen
Xuemin, Song
author_facet Yongping, Zheng
Xinyi, Li
Aming, Sang
Qiang, Xie
Tianqi, Zhou
Mengmeng, Shen
Xiong, Chen
Xuemin, Song
author_sort Yongping, Zheng
collection PubMed
description Background and Purpose: Data and high-quality studies of anesthetic methods for children with obstructive sleep apnea hypopnea syndrome (OSAHS) who undergo drug-induced sleep endoscopy (DISE) are limited. Research on pediatric DISE using esketamine has never been reported before. To test the safety and efficacy of esketamine during DISE in children with OSAHS, we compare esketamine (Group K) with dexmedetomidine (Group D) in this study. Methods: 100 children with ASA Ⅰ∼Ⅱ grade, prepared for an elective adenotonsillectomy under general anesthesia, were enrolled in this study and randomized into two groups. Midazolam 0.1 mg/kg was administered intravenously for both groups. In Group D a 1 μg/kg bolus of dexmedetomidine was given over 10 min followed by the infusion rate 1 μg/kg/hr to the end of DISE. Group K received a 1.0 mg/kg IV bolus of esketamine over 10 s followed by the infusion rate 1 mg/kg/hr to the end of DISE. Results: Group K had a higher percentage of success than Group D (p = 0.008). The onset time of Group K was shorter than that of Group D (p = 0.000). The University of Michigan Sedation Scale (UMSS) score of Group K was higher than that of Group D (p = 0.005). The risk of adverse effects (AEs) was lower in Group K (p = 0.000). In Group D, systolic and diastolic blood pressure (SBP and DBP) and heart rate (HR) all decreased, while in Group K, SBP, DBP, and HR hardly changed. Conclusion: Esketamine in comparison to dexmedetomidine provides more effective and safer depth of anesthesia for OSAHS pediatric DISE by ensuring short onset time, deep sedation, and few AEs. Clinical Trial Registration: ClincalTrials.gov, identifier NCT04877639
format Online
Article
Text
id pubmed-9751969
institution National Center for Biotechnology Information
language English
publishDate 2022
publisher Frontiers Media S.A.
record_format MEDLINE/PubMed
spelling pubmed-97519692022-12-16 The safety and efficacy of esketamine in comparison to dexmedetomidine during drug-induced sleep endoscopy in children with obstructive sleep apnea hypopnea syndrome: A randomized, controlled and prospective clinical trial Yongping, Zheng Xinyi, Li Aming, Sang Qiang, Xie Tianqi, Zhou Mengmeng, Shen Xiong, Chen Xuemin, Song Front Pharmacol Pharmacology Background and Purpose: Data and high-quality studies of anesthetic methods for children with obstructive sleep apnea hypopnea syndrome (OSAHS) who undergo drug-induced sleep endoscopy (DISE) are limited. Research on pediatric DISE using esketamine has never been reported before. To test the safety and efficacy of esketamine during DISE in children with OSAHS, we compare esketamine (Group K) with dexmedetomidine (Group D) in this study. Methods: 100 children with ASA Ⅰ∼Ⅱ grade, prepared for an elective adenotonsillectomy under general anesthesia, were enrolled in this study and randomized into two groups. Midazolam 0.1 mg/kg was administered intravenously for both groups. In Group D a 1 μg/kg bolus of dexmedetomidine was given over 10 min followed by the infusion rate 1 μg/kg/hr to the end of DISE. Group K received a 1.0 mg/kg IV bolus of esketamine over 10 s followed by the infusion rate 1 mg/kg/hr to the end of DISE. Results: Group K had a higher percentage of success than Group D (p = 0.008). The onset time of Group K was shorter than that of Group D (p = 0.000). The University of Michigan Sedation Scale (UMSS) score of Group K was higher than that of Group D (p = 0.005). The risk of adverse effects (AEs) was lower in Group K (p = 0.000). In Group D, systolic and diastolic blood pressure (SBP and DBP) and heart rate (HR) all decreased, while in Group K, SBP, DBP, and HR hardly changed. Conclusion: Esketamine in comparison to dexmedetomidine provides more effective and safer depth of anesthesia for OSAHS pediatric DISE by ensuring short onset time, deep sedation, and few AEs. Clinical Trial Registration: ClincalTrials.gov, identifier NCT04877639 Frontiers Media S.A. 2022-12-01 /pmc/articles/PMC9751969/ /pubmed/36532775 http://dx.doi.org/10.3389/fphar.2022.1036509 Text en Copyright © 2022 Yongping, Xinyi, Aming, Qiang, Tianqi, Mengmeng, Xiong and Xuemin. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Pharmacology
Yongping, Zheng
Xinyi, Li
Aming, Sang
Qiang, Xie
Tianqi, Zhou
Mengmeng, Shen
Xiong, Chen
Xuemin, Song
The safety and efficacy of esketamine in comparison to dexmedetomidine during drug-induced sleep endoscopy in children with obstructive sleep apnea hypopnea syndrome: A randomized, controlled and prospective clinical trial
title The safety and efficacy of esketamine in comparison to dexmedetomidine during drug-induced sleep endoscopy in children with obstructive sleep apnea hypopnea syndrome: A randomized, controlled and prospective clinical trial
title_full The safety and efficacy of esketamine in comparison to dexmedetomidine during drug-induced sleep endoscopy in children with obstructive sleep apnea hypopnea syndrome: A randomized, controlled and prospective clinical trial
title_fullStr The safety and efficacy of esketamine in comparison to dexmedetomidine during drug-induced sleep endoscopy in children with obstructive sleep apnea hypopnea syndrome: A randomized, controlled and prospective clinical trial
title_full_unstemmed The safety and efficacy of esketamine in comparison to dexmedetomidine during drug-induced sleep endoscopy in children with obstructive sleep apnea hypopnea syndrome: A randomized, controlled and prospective clinical trial
title_short The safety and efficacy of esketamine in comparison to dexmedetomidine during drug-induced sleep endoscopy in children with obstructive sleep apnea hypopnea syndrome: A randomized, controlled and prospective clinical trial
title_sort safety and efficacy of esketamine in comparison to dexmedetomidine during drug-induced sleep endoscopy in children with obstructive sleep apnea hypopnea syndrome: a randomized, controlled and prospective clinical trial
topic Pharmacology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9751969/
https://www.ncbi.nlm.nih.gov/pubmed/36532775
http://dx.doi.org/10.3389/fphar.2022.1036509
work_keys_str_mv AT yongpingzheng thesafetyandefficacyofesketamineincomparisontodexmedetomidineduringdruginducedsleependoscopyinchildrenwithobstructivesleepapneahypopneasyndromearandomizedcontrolledandprospectiveclinicaltrial
AT xinyili thesafetyandefficacyofesketamineincomparisontodexmedetomidineduringdruginducedsleependoscopyinchildrenwithobstructivesleepapneahypopneasyndromearandomizedcontrolledandprospectiveclinicaltrial
AT amingsang thesafetyandefficacyofesketamineincomparisontodexmedetomidineduringdruginducedsleependoscopyinchildrenwithobstructivesleepapneahypopneasyndromearandomizedcontrolledandprospectiveclinicaltrial
AT qiangxie thesafetyandefficacyofesketamineincomparisontodexmedetomidineduringdruginducedsleependoscopyinchildrenwithobstructivesleepapneahypopneasyndromearandomizedcontrolledandprospectiveclinicaltrial
AT tianqizhou thesafetyandefficacyofesketamineincomparisontodexmedetomidineduringdruginducedsleependoscopyinchildrenwithobstructivesleepapneahypopneasyndromearandomizedcontrolledandprospectiveclinicaltrial
AT mengmengshen thesafetyandefficacyofesketamineincomparisontodexmedetomidineduringdruginducedsleependoscopyinchildrenwithobstructivesleepapneahypopneasyndromearandomizedcontrolledandprospectiveclinicaltrial
AT xiongchen thesafetyandefficacyofesketamineincomparisontodexmedetomidineduringdruginducedsleependoscopyinchildrenwithobstructivesleepapneahypopneasyndromearandomizedcontrolledandprospectiveclinicaltrial
AT xueminsong thesafetyandefficacyofesketamineincomparisontodexmedetomidineduringdruginducedsleependoscopyinchildrenwithobstructivesleepapneahypopneasyndromearandomizedcontrolledandprospectiveclinicaltrial
AT yongpingzheng safetyandefficacyofesketamineincomparisontodexmedetomidineduringdruginducedsleependoscopyinchildrenwithobstructivesleepapneahypopneasyndromearandomizedcontrolledandprospectiveclinicaltrial
AT xinyili safetyandefficacyofesketamineincomparisontodexmedetomidineduringdruginducedsleependoscopyinchildrenwithobstructivesleepapneahypopneasyndromearandomizedcontrolledandprospectiveclinicaltrial
AT amingsang safetyandefficacyofesketamineincomparisontodexmedetomidineduringdruginducedsleependoscopyinchildrenwithobstructivesleepapneahypopneasyndromearandomizedcontrolledandprospectiveclinicaltrial
AT qiangxie safetyandefficacyofesketamineincomparisontodexmedetomidineduringdruginducedsleependoscopyinchildrenwithobstructivesleepapneahypopneasyndromearandomizedcontrolledandprospectiveclinicaltrial
AT tianqizhou safetyandefficacyofesketamineincomparisontodexmedetomidineduringdruginducedsleependoscopyinchildrenwithobstructivesleepapneahypopneasyndromearandomizedcontrolledandprospectiveclinicaltrial
AT mengmengshen safetyandefficacyofesketamineincomparisontodexmedetomidineduringdruginducedsleependoscopyinchildrenwithobstructivesleepapneahypopneasyndromearandomizedcontrolledandprospectiveclinicaltrial
AT xiongchen safetyandefficacyofesketamineincomparisontodexmedetomidineduringdruginducedsleependoscopyinchildrenwithobstructivesleepapneahypopneasyndromearandomizedcontrolledandprospectiveclinicaltrial
AT xueminsong safetyandefficacyofesketamineincomparisontodexmedetomidineduringdruginducedsleependoscopyinchildrenwithobstructivesleepapneahypopneasyndromearandomizedcontrolledandprospectiveclinicaltrial