Feasibility of low-dose dexmedetomidine for prevention of postoperative delirium after intracranial operations: a pilot randomized controlled trial

Abstract Background Clinical trials have shown that dexmedetomidine might decrease the occurrence of postoperative delirium after major surgery, but neurosurgical patients were excluded from these studies. We aimed to determine the feasibility of conducting a full-scale randomized controlled trial o...

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Autores principales:	Xuan He, Kun-Ming Cheng, Yu-Qing Duan, Shan-Shan Xu, Hao-Ran Gao, Ming-Yue Miao, Hong-Liang Li, Kai Chen, Yan-Lin Yang, Linlin Zhang, Hong-Qiu Gu, Jian-Xin Zhou
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Delirium Postoperative Intracranial operation Prevention Dexmedetomidine Neurology. Diseases of the nervous system RC346-429
Acceso en línea:	https://doaj.org/article/8c8cbdb1f8f1484fa92de1684bec30aa
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spelling	oai:doaj.org-article:8c8cbdb1f8f1484fa92de1684bec30aa2021-12-05T12:08:55ZFeasibility of low-dose dexmedetomidine for prevention of postoperative delirium after intracranial operations: a pilot randomized controlled trial10.1186/s12883-021-02506-z1471-2377https://doaj.org/article/8c8cbdb1f8f1484fa92de1684bec30aa2021-12-01T00:00:00Zhttps://doi.org/10.1186/s12883-021-02506-zhttps://doaj.org/toc/1471-2377Abstract Background Clinical trials have shown that dexmedetomidine might decrease the occurrence of postoperative delirium after major surgery, but neurosurgical patients were excluded from these studies. We aimed to determine the feasibility of conducting a full-scale randomized controlled trial of the effect of prophylactic low-dose dexmedetomidine on postoperative delirium in patients after elective intracranial operation for brain tumors. Methods In this single-center, parallel-arm pilot randomized controlled trial, adult patients who underwent an elective intracranial operation for brain tumors were recruited. Dexmedetomidine (0.1 μg/kg/hour) or placebo was continuously infused from intensive care unit (ICU) admission on the day of surgery until 08:00 AM on postoperative day one. Adverse events during the study-drug administration were recorded. The primary feasibility endpoint was the occurrence of study-drug interruption. Delirium was assessed twice daily with the Confusion Assessment Method for the ICU during the first five postoperative days. The assessable rate of delirium evaluation was documented. Results Sixty participants were randomly assigned to receive either dexmedetomidine (n = 30) or placebo (n = 30). The study-drug was stopped in two patients (6.7%) in the placebo group due to desaturation after new-onset unconsciousness and an unplanned reoperation for hematoma evacuation and in one patient (3.3%) in the dexmedetomidine group due to unplanned discharge from the ICU. The absolute difference (95% confidence interval) of study-drug interruption between the two groups was 3.3% (− 18.6 to 12.0%), with a noninferiority P value of 0.009. During the study-drug infusion, no bradycardia occurred, and hypotension occurred in one patient (3.3%) in the dexmedetomidine group. Dexmedetomidine tended to decrease the incidence of tachycardia (10.0% vs. 23.3%) and hypertension (3.3% vs. 23.3%). Respiratory depression, desaturation, and unconsciousness occurred in the same patient with study-drug interruption in the placebo group (3.3%). Delirium was evaluated 600 times, of which 590 (98.3%) attempts were assessable except in one patient in the placebo group who remained in a coma after an unplanned reoperation. Conclusions The low rate of study-drug interruption and high assessable rate of delirium evaluation supported a fully powered trial to determine the effectiveness of low-dose dexmedetomidine on postoperative delirium in patients after intracranial operation for brain tumors. Trial registration The trial was registered at ClinicalTrials.gov (NCT04494828) on 31/07/2020.Xuan HeKun-Ming ChengYu-Qing DuanShan-Shan XuHao-Ran GaoMing-Yue MiaoHong-Liang LiKai ChenYan-Lin YangLinlin ZhangHong-Qiu GuJian-Xin ZhouBMCarticleDeliriumPostoperativeIntracranial operationPreventionDexmedetomidineNeurology. Diseases of the nervous systemRC346-429ENBMC Neurology, Vol 21, Iss 1, Pp 1-12 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Delirium Postoperative Intracranial operation Prevention Dexmedetomidine Neurology. Diseases of the nervous system RC346-429
spellingShingle	Delirium Postoperative Intracranial operation Prevention Dexmedetomidine Neurology. Diseases of the nervous system RC346-429 Xuan He Kun-Ming Cheng Yu-Qing Duan Shan-Shan Xu Hao-Ran Gao Ming-Yue Miao Hong-Liang Li Kai Chen Yan-Lin Yang Linlin Zhang Hong-Qiu Gu Jian-Xin Zhou Feasibility of low-dose dexmedetomidine for prevention of postoperative delirium after intracranial operations: a pilot randomized controlled trial
description	Abstract Background Clinical trials have shown that dexmedetomidine might decrease the occurrence of postoperative delirium after major surgery, but neurosurgical patients were excluded from these studies. We aimed to determine the feasibility of conducting a full-scale randomized controlled trial of the effect of prophylactic low-dose dexmedetomidine on postoperative delirium in patients after elective intracranial operation for brain tumors. Methods In this single-center, parallel-arm pilot randomized controlled trial, adult patients who underwent an elective intracranial operation for brain tumors were recruited. Dexmedetomidine (0.1 μg/kg/hour) or placebo was continuously infused from intensive care unit (ICU) admission on the day of surgery until 08:00 AM on postoperative day one. Adverse events during the study-drug administration were recorded. The primary feasibility endpoint was the occurrence of study-drug interruption. Delirium was assessed twice daily with the Confusion Assessment Method for the ICU during the first five postoperative days. The assessable rate of delirium evaluation was documented. Results Sixty participants were randomly assigned to receive either dexmedetomidine (n = 30) or placebo (n = 30). The study-drug was stopped in two patients (6.7%) in the placebo group due to desaturation after new-onset unconsciousness and an unplanned reoperation for hematoma evacuation and in one patient (3.3%) in the dexmedetomidine group due to unplanned discharge from the ICU. The absolute difference (95% confidence interval) of study-drug interruption between the two groups was 3.3% (− 18.6 to 12.0%), with a noninferiority P value of 0.009. During the study-drug infusion, no bradycardia occurred, and hypotension occurred in one patient (3.3%) in the dexmedetomidine group. Dexmedetomidine tended to decrease the incidence of tachycardia (10.0% vs. 23.3%) and hypertension (3.3% vs. 23.3%). Respiratory depression, desaturation, and unconsciousness occurred in the same patient with study-drug interruption in the placebo group (3.3%). Delirium was evaluated 600 times, of which 590 (98.3%) attempts were assessable except in one patient in the placebo group who remained in a coma after an unplanned reoperation. Conclusions The low rate of study-drug interruption and high assessable rate of delirium evaluation supported a fully powered trial to determine the effectiveness of low-dose dexmedetomidine on postoperative delirium in patients after intracranial operation for brain tumors. Trial registration The trial was registered at ClinicalTrials.gov (NCT04494828) on 31/07/2020.
format	article
author	Xuan He Kun-Ming Cheng Yu-Qing Duan Shan-Shan Xu Hao-Ran Gao Ming-Yue Miao Hong-Liang Li Kai Chen Yan-Lin Yang Linlin Zhang Hong-Qiu Gu Jian-Xin Zhou
author_facet	Xuan He Kun-Ming Cheng Yu-Qing Duan Shan-Shan Xu Hao-Ran Gao Ming-Yue Miao Hong-Liang Li Kai Chen Yan-Lin Yang Linlin Zhang Hong-Qiu Gu Jian-Xin Zhou
author_sort	Xuan He
title	Feasibility of low-dose dexmedetomidine for prevention of postoperative delirium after intracranial operations: a pilot randomized controlled trial
title_short	Feasibility of low-dose dexmedetomidine for prevention of postoperative delirium after intracranial operations: a pilot randomized controlled trial
title_full	Feasibility of low-dose dexmedetomidine for prevention of postoperative delirium after intracranial operations: a pilot randomized controlled trial
title_fullStr	Feasibility of low-dose dexmedetomidine for prevention of postoperative delirium after intracranial operations: a pilot randomized controlled trial
title_full_unstemmed	Feasibility of low-dose dexmedetomidine for prevention of postoperative delirium after intracranial operations: a pilot randomized controlled trial
title_sort	feasibility of low-dose dexmedetomidine for prevention of postoperative delirium after intracranial operations: a pilot randomized controlled trial
publisher	BMC
publishDate	2021
url	https://doaj.org/article/8c8cbdb1f8f1484fa92de1684bec30aa
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Feasibility of low-dose dexmedetomidine for prevention of postoperative delirium after intracranial operations: a pilot randomized controlled trial

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