Therapeutic effect of small-dose remifentanil infusion on severe emergence agitation after general anesthesia for major abdominal surgery in adults: Study protocol for a randomized and controlled trial (RF-TEA Trial)

Abstract

Background Emergence agitation (EA) after general anesthesia is one of the most common complications in the postanesthesia care unit (PACU). However, there are still no currently established guidelines for the treatment of EA in adults. Previous studies have shown that continuous infusion of remifentanil during recovery has a preventive effect on the occurrence of EA. One report showed that remifentanil can reduce the recurrence rate of moderate EA, but no studies have evaluated the therapeutic effects of remifentanil on severe EA and circulating cytokine levels. This study aims to observe the therapeutic effect of small-dose remifentanil infusion on severe EA and circulating cytokine levels in adult patients who underwent major abdominal surgery. Methods In this randomized controlled clinical study, we will enroll a total of 80 adult patients aged 18–75 years who underwent hepatobiliary and pancreatic surgery and had American Society of Anesthesiologists classification I-III severe EA in the PACU. Severe EA was defined as a score of ≥ 6 using the Riker Sedation-Agitation Scale. Patients will be randomized at a 1:1 ratio into two groups, receiving either a bolus of 1 µg/kg remifentanil injection followed by a 0.1 µg/kg·min infusion in the remifentanil group or the same volume of normal saline in the control group. The primary objective is to observe the therapeutic effect of remifentanil on severe EA in adults after general anesthesia in the PACU. Circulating cytokine concentrations will be determined during the emergence period. Discussion There is no currently established method for the treatment of EA. Previous studies have focused on the preventative effect of remifentanil on EA. There are no studies on the therapeutic effect of remifentanil on severe EA. To our knowledge, this will be the first randomized and controlled trial conducted to observe the therapeutic effect of small-dose remifentanil infusion on severe EA after general anesthesia for major abdominal surgery in adult patients and on circulating cytokine concentrations during the emergence period. Trial registration: ChiCTR2300072522. Registered on June 15, 2023