Remifentanil versus dexmedetomidine for treatment of cardiac surgery patients with moderate to severe noninvasive ventilation intolerance (REDNIVIN): a prospective, cohort study

Abstract

Background: The use of sedation to noninvasive ventilation (NIV) patients remains controversial, however, for intolerant patients who are uncooperative, administration of analgesics and sedatives may be beneficial before resorting to intubation. The aim of this study was to evaluate the efficacy of remifentanil (REM) versus dexmedetomidine (DEX) for treatment of cardiac surgery (CS) patients with moderate to severe NIV intolerance. Methods: This prospective cohort study of CS patients with moderate to severe NIV intolerance was conducted between January 2018 and March 2019. Patients were treated with either REM or DEX, decided by the bedside intensivist. Depending on the treatment regimen, the patients were allocated to one of two groups: the REM group or DEX group. Results: A total of 90 patients were enrolled in this study (52 in the REM group and 38 in the DEX group).The mitigation rate, defined as the percentage of patients who were relieved from the initial moderate to severe intolerant status, was greater in the REM group than DEX group at 15 min and 3 h (15 min: 83% vs. 61%, P=0.029; 3 h: 92% vs. 74%, P=0.016), although the mean mitigation rate (81% vs. 85%, P=0.800) was comparable between the two groups. NIV failure, defined as reintubation or death over the course of study, was comparable between the two groups (19.2% vs. 21.1%, respectively, P=0.831). There were no significant differences between the two groups in other clinical outcomes, including tracheostomy (15.4% vs.15.8%, P=0.958), in-hospital mortality (11.5% vs. 10.5%, P=0.880), ICU length of stay (LOS) (7 vs. 7 days, P=0.802), and in-hospital LOS (17 vs. 19 days, P=0.589). Conclusions: REM was as effective as DEX in CS patients with moderate to severe NIV intolerance.Although the effect of REM was better than that of DEX over the first 3 h, the cumulative effect was similar between the two treatments.

Comfort During Non-invasive Ventilation

“…Remifentanil is a short-acting opioid proven to be safe and effective to achieve optimal sedation in case of intolerance to NIV ( 96 ). In keeping with a recent investigation ( 97 ), a remifentanil-based sedation plan has demonstrated the same efficacy in ameliorating moderate to severe NIV intolerance, as dexmedetomidine.…”

Comparison of clinical safety and efficacy of dexmedetomidine, remifentanil, and propofol in patients who cannot tolerate non-invasive mechanical ventilation: A prospective, randomized, cohort study

“…The side effects of both drugs were rare (chest wall rigidity in one patient with remifentanil, and severe hemodynamic instability requiring intubation with dexmedetomidine). In addition, NIV failure was avoided in more than 80% of the patients enrolled in this study ( 21 ). We also did not find any differences between the groups in terms of the incidence of side effects ( P > 0.05).…”

“…In the first hour of NIV administration, NIV intolerance was assessed using the NIV intolerance score (NIS). The NIS included four points; 1, a comfortable patient tolerating NIV; 2, a mildly intolerant patient who felt some degree of discomfort and occasionally grabbed at the NIV mask; 3, moderate intolerance and discomfort (sometimes pulling), most often with NIV mask, with frequent grabbing at the mask; 4, severe NIV intolerance with an agitation unable to keep the NIV mask on the face ( 21 ). According to this scoring, patients who scored 3 and 4 were considered to have NIV intolerance.…”

Remifentanil versus Dexmedetomidine in Cardiac Surgery Patients with Noninvasive Ventilation Intolerance: Protocol for the REDNIVI Trial

“…The primary objective of this study is to compare the remission rate of REM and DEX in patients with NIV intolerance after cardiac surgery. A previous study comparing the average remission rate within 3 hours after initiation of treatment showed the average remission rate was 88% for the REM group and 70% for the DEX group [18]. Thus the sample size was calculated as 80 subjects in each group.…”

“…Various methods have been adopted to prevent and treat NIV intolerance, including sedation, thus preventing endotracheal intubation [16,17]. Our preliminary research concerning the treatment of cardiac surgery (CS) patients with moderate to severe NIV intolerance has showm that after sedation, endotracheal intubation was avoided in about 80% of the intolerant patients [18]. Dexmedetomidine (DEX) is a selective α-2 agonist that downregulates the release of norepinephrine in the central nervous system without suppressing breathing [19].…”