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 | ||||
| RASSa, 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 populationb | 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 populationb | − 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 Questionnaired, 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)