Comparing the effects of dexmedetomidine versus propofol on the treatment of emergence agitation in adult patients after general anesthesia: study protocol for a randomized, superiority, controlled trial (DP-TEA Trial)

Abstract Background Emergence agitation (EA) after general anesthesia is a common complication in the post-anesthesia care unit (PACU). Once EA occurs, there are still no guidelines established for the treatment in adults. Propofol is excessively used in managing agitated patients in the PACU, but i...

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Autores principales:	Zhaoyan Feng, Xiao Shi, Xue Yan, Yamin Zhu, Juan Gu, Hao Zhu, Weifeng Yu, Song Zhang
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Emergence agitation Dexmedetomidine Propofol Adult patient Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/7a8e7aea0f424584a259798a67fe73c7
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spelling	oai:doaj.org-article:7a8e7aea0f424584a259798a67fe73c72021-11-21T12:31:24ZComparing the effects of dexmedetomidine versus propofol on the treatment of emergence agitation in adult patients after general anesthesia: study protocol for a randomized, superiority, controlled trial (DP-TEA Trial)10.1186/s13063-021-05743-21745-6215https://doaj.org/article/7a8e7aea0f424584a259798a67fe73c72021-11-01T00:00:00Zhttps://doi.org/10.1186/s13063-021-05743-2https://doaj.org/toc/1745-6215Abstract Background Emergence agitation (EA) after general anesthesia is a common complication in the post-anesthesia care unit (PACU). Once EA occurs, there are still no guidelines established for the treatment in adults. Propofol is excessively used in managing agitated patients in the PACU, but it lacks analgesia and can result in apnea. Intraoperative infusion of dexmedetomidine has been proven to have a preventive effect on EA, but the treatment effect of dexmedetomidine on EA remains unknown. This study aims to compare the effects between dexmedetomidine and propofol on relieving EA in adult patients after general anesthesia in the PACU. Methods In this randomized, superiority, controlled clinical study, a total of 120 adult patients aged 18–65 years of both genders, with American Society of Anesthesiologists (ASA) classification I or II developing EA in the PACU after general anesthesia, will be enrolled. Patients will be randomized at a 1:1 ratio into two groups, receiving either a single dose of dexmedetomidine (0.7μg/kg) or propofol (0.5 mg/kg). The primary outcome is the proportion of patients having a recurrent EA within 15 min after intervention in the PACU. Discussion Previous studies have focused on premedication for preventing EA, while therapeutics for reliving EA have rarely been reported. To our knowledge, this study is the first randomized, superiority, controlled trial to compare a bolus of dexmedetomidine with the current routine care for this indication. Trial registration ClinicalTrials.gov NCT04142840 . Registered on October 26, 2019Zhaoyan FengXiao ShiXue YanYamin ZhuJuan GuHao ZhuWeifeng YuSong ZhangBMCarticleEmergence agitationDexmedetomidinePropofolAdult patientMedicine (General)R5-920ENTrials, Vol 22, Iss 1, Pp 1-9 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Emergence agitation Dexmedetomidine Propofol Adult patient Medicine (General) R5-920
spellingShingle	Emergence agitation Dexmedetomidine Propofol Adult patient Medicine (General) R5-920 Zhaoyan Feng Xiao Shi Xue Yan Yamin Zhu Juan Gu Hao Zhu Weifeng Yu Song Zhang Comparing the effects of dexmedetomidine versus propofol on the treatment of emergence agitation in adult patients after general anesthesia: study protocol for a randomized, superiority, controlled trial (DP-TEA Trial)
description	Abstract Background Emergence agitation (EA) after general anesthesia is a common complication in the post-anesthesia care unit (PACU). Once EA occurs, there are still no guidelines established for the treatment in adults. Propofol is excessively used in managing agitated patients in the PACU, but it lacks analgesia and can result in apnea. Intraoperative infusion of dexmedetomidine has been proven to have a preventive effect on EA, but the treatment effect of dexmedetomidine on EA remains unknown. This study aims to compare the effects between dexmedetomidine and propofol on relieving EA in adult patients after general anesthesia in the PACU. Methods In this randomized, superiority, controlled clinical study, a total of 120 adult patients aged 18–65 years of both genders, with American Society of Anesthesiologists (ASA) classification I or II developing EA in the PACU after general anesthesia, will be enrolled. Patients will be randomized at a 1:1 ratio into two groups, receiving either a single dose of dexmedetomidine (0.7μg/kg) or propofol (0.5 mg/kg). The primary outcome is the proportion of patients having a recurrent EA within 15 min after intervention in the PACU. Discussion Previous studies have focused on premedication for preventing EA, while therapeutics for reliving EA have rarely been reported. To our knowledge, this study is the first randomized, superiority, controlled trial to compare a bolus of dexmedetomidine with the current routine care for this indication. Trial registration ClinicalTrials.gov NCT04142840 . Registered on October 26, 2019
format	article
author	Zhaoyan Feng Xiao Shi Xue Yan Yamin Zhu Juan Gu Hao Zhu Weifeng Yu Song Zhang
author_facet	Zhaoyan Feng Xiao Shi Xue Yan Yamin Zhu Juan Gu Hao Zhu Weifeng Yu Song Zhang
author_sort	Zhaoyan Feng
title	Comparing the effects of dexmedetomidine versus propofol on the treatment of emergence agitation in adult patients after general anesthesia: study protocol for a randomized, superiority, controlled trial (DP-TEA Trial)
title_short	Comparing the effects of dexmedetomidine versus propofol on the treatment of emergence agitation in adult patients after general anesthesia: study protocol for a randomized, superiority, controlled trial (DP-TEA Trial)
title_full	Comparing the effects of dexmedetomidine versus propofol on the treatment of emergence agitation in adult patients after general anesthesia: study protocol for a randomized, superiority, controlled trial (DP-TEA Trial)
title_fullStr	Comparing the effects of dexmedetomidine versus propofol on the treatment of emergence agitation in adult patients after general anesthesia: study protocol for a randomized, superiority, controlled trial (DP-TEA Trial)
title_full_unstemmed	Comparing the effects of dexmedetomidine versus propofol on the treatment of emergence agitation in adult patients after general anesthesia: study protocol for a randomized, superiority, controlled trial (DP-TEA Trial)
title_sort	comparing the effects of dexmedetomidine versus propofol on the treatment of emergence agitation in adult patients after general anesthesia: study protocol for a randomized, superiority, controlled trial (dp-tea trial)
publisher	BMC
publishDate	2021
url	https://doaj.org/article/7a8e7aea0f424584a259798a67fe73c7
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Comparing the effects of dexmedetomidine versus propofol on the treatment of emergence agitation in adult patients after general anesthesia: study protocol for a randomized, superiority, controlled trial (DP-TEA Trial)

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