Prevention of post-operative delirium using an overnight infusion of dexmedetomidine in patients undergoing cardiac surgery: a pragmatic, randomized, double-blind, placebo-controlled trial

Table 2 Outcomes in the study participants assigned to dexmedetomidine or placebo group. Data are expressed as number (%), mean (SD) or median (IQR) as appropriate

Outcomes	Total (n = 331)	Dexmedetomidine group (n = 165)	Placebo group (n = 166)	P
Primary outcome
PoD within the 7 days after surgery, n (%)	40 (12.5)	20 (12.6)	20 (12.4)	0.97
Missing	11	6	5
Secondary outcomes
RASS^a, mean (SD)
Minimum RASS score	− 0.5 (0.8)	− 0.6 (0.9)	− 0.5 (0.7)	0.76
Maximum RASS score	− 0.1 (0.7)	− 0.2 (0.8)	− 0.1 (0.6)	0.92
Missing	10	6	4
Agitation-related adverse events, n (%)	29 (8.7)	15 (9.1)	14 (8.4)	0.83
Sleep quality evaluation
Numerical scale, median (IQR)
Intention-to-treat population	5.3 (4.3–6.4)	5.2 (4.3–6.4)	5.3 (4.3–6.4)	0.98
Missing	32	13	19
As-treated population^b	5.3 (3.5–7.0)	5.7 (4.0–7.0)	5.0 (3.0–6.8)	0.01
Missing	29	11	18
LSEQ, median (IQR)
Intention-to-treat population	− 4.0 (− 9.3–3.5)	− 4.0 (− 8.9–3.7)	− 4.2 (− 9.9–3.2)	0.32
Missing	27	13	14
As-treated population^b	− 5.0 (− 11.8–3.0)	− 4.0 (− 10.6–4.0)	− 7.3 (− 14.8–1.5)	0.02
Missing	30	14	16
Functional outcomes evaluated at 3 months
Short-Form 36 ^c, mean (SD)
Physical component	44.1 (8.5)	45 (8.9)	43.3 (8.1)	0.13
Mental component	50.1 (9.8)	51 (9.5)	49.3 (10.1)	0.23
Missing	92	46	46
Cognitive Failure Questionnaire^d, mean (SD)	24.5 (13.2)	23.7 (13.6)	25.4 (12.9)	0.45
Missing	111	51	60
PTSD, n (%)	8 (3.6)	2 (1.9)	6 (5.2)	0.28
Missing	109	59	50
Other outcomes
ICU length of stay, median (IQR)	3 (2–5)	3 (2–5)	3 (2–5)	0.85
Hospital length of stay, median (IQR)	11 (8–15)	11 (8–16)	11 (8–15)	0.83
Hospital mortality, n (%)	6 (1.8)	5 (3)	1 (0.6)	0.12
Mortality at 3 months, n (%)	11 (3.3)	8 (4.8)	3 (1.8)	0.12

CAM-ICU Confusion Assessment Method for the Intensive Care Unit, LSEQ Leeds Sleep Evaluation Questionnaire, PoD Postoperative Delirium, PTSD Post Traumatic Stress Disorder, RASS Richmond Agitation-Sedation Scale, SD Standard Deviation
^aMean of the minimum and maximum RASS score was summarized in this table
^bAs-treated analysis (n = 312) was done on patients who received the treatment, dexmedetomidine (n = 153) or placebo (n = 159), the night before the sleep quality evaluation
^cFor SF-36 questionnaire: a higher mean score in physical and mental components are related to higher quality of life
^dFor cognitive failure questionnaire: a higher mean score is related to more cognitive dysfunction (see appendix 1 for more details)

ISSN: 1364-8535