Variables | Dexmedetomidine group (n = 251) | Placebo group (n = 257) | OR (95%CI) | P value |
---|---|---|---|---|
Primary endpoint | ||||
PICS at 6-month after discharge # | 54(21.5%) | 80(31.1%) | 0.793(0.665–0.945) | 0.014 |
Individual component of the primary end point | ||||
Cognitive impairment by MMSE a | 10(4.0%) | 17(6.6%) | 0.792(0.585–1.073) | 0.186 |
Psychological impairment by SAS and SDS b,c# | 47(18.7%) | 69(26.8%) | 0.806(0.672–0.967) | 0.029 |
Physical impairment by Barthel index d | 7(2.8%) | 13(5.1%) | 0.769(0.551–1.074) | 0.188 |
Secondary endpoints | ||||
Mortality in hospitalization, No (%) | 2(0.8%) | 1(0.4%) | 1.521(0.306–7.522) | 0.549 |
Mortality within 6 months, No (%) | 3(1.2%) | 4(1.6%) | 0.884(0.463–1.688) | 0.727 |
PICS at 3 months after discharge # | 79 (31.5%) | 110 (42.8%) | 0.792(0.668–0.938) | 0.008 |
Cognitive impairment* | 18(7.2%) | 29(11.3%) | 0.802(0.628–1.022) | 0.11 |
Psychological impairment*,# | 58(23.1%) | 84(32.7%) | 0.799(0.671–0.951) | 0.016 |
Disability*,# | 16(6.4%) | 34(13.2%) | 0.716(0.579–0.885) | 0.01 |
ICU stay | 3.0(2.0,4.0) | 3.0(2.0,4.0) | - | 0.642 |
Length of hospital stay | 8(7.0,10.0) | 8(7.0,11.0) | - | 0.157 |
Tracheal intubation time | 13(9,16) | 13(9,17) | - | 0.346 |
Retracheal intubation | 2(0.8%) | 5(1.9%) | 0.704(0.437–1.134) | 0.267 |
Acute kidney injury | 3(1.2%) | 2(0.8%) | 1.267(0.432–3.721) | 0.634 |
Delirium | 19 (7.6%) | 31 (12.1%) | 0.796(0.629–1.008) | 0.089 |
Postoperative atrial fibrillation | 57 (22.7%) | 80 (31.1%) | 0.817(0.684–0.975) | 0.033 |
Safety outcomes | ||||
Any adverse event occurred # | 45(17.9%) | 26(10.1%) | 1.443(1.050–1.985) | 0.011 |
Hypotension after treatment initiation # | 32(12.7%) | 17(6.6%) | 1.507(1.016–2.235) | 0.019 |
Bradycardia after treatment | 17(6.8%) | 12(4.7%) | 1.236(0.795–1.923) | 0.307 |
Extra fluid intervention | 13(5.2%) | 6(2.3%) | 1.625(0.834–3.168) | 0.091 |
Extra vasoconstrictor intervention | 7(2.8%) | 4(1.6%) | 1.4(0.638–3.074) | 0.34 |