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).
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.
['Feng|Zhaoyan|Z|', 'Shi|Xiao|X|', 'Yan|Xue|X|', 'Zhu|Yamin|Y|', 'Gu|Juan|J|', 'Zhu|Hao|H|', 'Yu|Weifeng|W|', 'Zhang|Song|S|']
D000328:Adult D000762:Anesthesia Recovery Period D000768:Anesthesia, General D020927:Dexmedetomidine D000071257:Emergence Delirium D005260:Female D006801:Humans D008297:Male D015742:Propofol D016032:Randomized Controlled Trials as Topic
Dexmedetomidine Propofol Emergence agitation Adult patient