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)

Trials

Weifeng Yu¹  Juan Gu¹  Hao Zhu¹  Xiao Shi¹  Xue Yan¹  Song Zhang¹  Yamin Zhu¹  Zhaoyan Feng² 

[1] Department of Anesthesiology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, No. 160 Pujian Road, 200127, Shanghai, China;Department of Anesthesiology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, No. 160 Pujian Road, 200127, Shanghai, China;Department of Anesthesiology, Shanghai Jiao Tong University Affiliated Sixth People’s Hospital, No. 600 Yishan Road, 200233, Shanghai, China;

关键词: Emergence agitation;    Dexmedetomidine;    Propofol;    Adult patient;   

DOI  :  10.1186/s13063-021-05743-2

来源: Springer

【 摘 要 】

BackgroundEmergence 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.MethodsIn 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.DiscussionPrevious 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 registrationClinicalTrials.govNCT04142840. Registered on October 26, 2019

【 授权许可】

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