Different Sedation Strategies in Older Patients Receiving Spinal Anesthesia for Hip Surgery on Postoperative Delirium: A Randomized Clinical Trial

Figures & data

Figure 1 CONSORT 2010 Flow Diagram.

Notes: Schulz KF, Altman DG, Moher D.CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomised Trials. PLoS Med. 2010;7(3): e1000251.²⁰ Copyright: © 2010 Schulz et al. Creative Commons Attribution License.

Table 1 Baseline Characteristics of Included Patients

Characteristic	Propofol Sedation (n = 110)	Dexmedetomidine Sedation (n = 109)
Age (years), M (P25, P75)	75 (72,82)	80 (71,84)
Male, n (%)	54 (49.1)	42 (38.5)
Educational level(years), M (P25, P75)	5(2,7)	4(2,6)
BMI (kg/m^2), mean ± SD	24.33±3.7	24.09±4.3
ASA, n (%)
II	48 (43.6)	38 (34.9)
III	62 (56.4)	52 (65.1)
MMSE, M (P25, P75)	27 (25, 28)	27 (25, 28)
The Barthel index of ADL, M (P25, P75)	30 (25, 40)	30 (25, 45)
Hemoglobin (g/dL), mean ± SD	116.8±14.4	114.5±12.1
Albumin (g/L), mean ± SD	36.1±3.4	35.7±3.9
Homocysteine (g/L), M (P25, P75)	12.9 (10.4,18.2)	13.8 (10.5,17.6)
ACCI, M (P25, P75)	4 (3, 5)	5 (4, 6)
Type of surgery, n (%)
Total hip arthroplasty with/without cement	39 (35.5)	40 (36.7)
Hemiarthroplasty with/without cement	32 (29.1)	31 (28.4)
Intramedullary nail	39 (35.5)	38 (34.9)

Notes: Data for BMI, hemoglobin and albumin at baseline were presented as mean ± standard deviation. Data for age, the years of educational level, homocysteine, the scores of MMSE and the Barthel index of ADL at baseline were presented as median (25th percentile, 75th percentile). Other data were presented as number (percentage). No statistically differences between groups were noted.

Abbreviations: BMI, body mass index. ASA, American Society of Anesthesiologists; MMSE, Mini-Mental State Examination; ADL, Activities of Daily Living; ACCI, Age-adjusted Charlson Comorbidity Index.

Table 2 Intraoperative Characteristics by Randomization Group

Parameter	Propofol Sedation (n=110)	Dexmedetomidine Sedation (n=109)	P-value
MAP (mmHg), mean ± SD
T1	86±6	87±5	0.479
T2	78±6	79±6	0.507
T3	82±5	83±5	0.599
HR (beat/min), mean ± SD
T1	74±9	75±8	0.789
T2	67±9	70±8	0.163
T3	71±8	73±7	0.275
Intraoperative fluid (mL), mean ± SD	772 ± 278	700 ± 310	0.182
Estimated blood loss (mL), mean ± SD	234 ± 159	262 ± 153	0.324
Duration of surgery (min), M (P25, P75)	82 (65,105)	85 (64,105)	0.932

Notes: Data for the duration of surgery was presented as median (25th percentile, 75th percentile). Other data were presented as mean ± standard deviation. No statistically significant differences between groups were noted.

Abbreviations: MAP, mean atrial pressure; HR, heart rate; T1, after arriving in the operating room and before sedation; T2, at the end of the administration of the sedative drug; T3, in the ward.

Table 3 Adverse Events According to Sedation Group

	Propofol Sedation (n = 110)	Dexmedetomidine Sedation (n = 109)	P-value
Intraoperative events, n (%)
Bradycardia	20 (18.2)	28 (25.7)	0.179
Tachycardia	2 (1.8)	1 (0.9)	>0.999
Hypertension	1 (0.9)	5 (4.6)	0.119
Hypotension	10 (9.1)	18 (16.5)	0.100
Hypoxemia	3(2.7)	2(1.8)	0.657
Hypercarbia	6(5.5)	1(0.9)	0.127
Postoperative events, n (%)
Nausea and vomiting	6 (5.5)	2 (1.8)	0.280
Pneumonia	1 (0.9)	0	>0.999
Hypotension	2 (1.8)	0	0.498
Hypertension	2 (1.8)	3 (2.8)	0.683
Myocardial ischemia	1 (0.9)	0	>0.999

Notes: Data were shown with the number (percentage). No statistically significant differences between groups were noted.

Table 4 Effect of Sedatives on Postoperative Delirium

Outcome	Propofol (n = 110)	Dexmedetomidine (n = 109)	Risk Ratio (95% CI)	P-value
Any delirium, n (%)	26 (23.6)	13 (11.9)	0.51(0.274 to 0.929)	0.024*
Motoric subtype of delirium, n (%)^a
Hypoactive	12 (10.9)	10 (9.2)	0.84(0.379 to 1.865)	0.669
Hyperactive	13 (11.8)	2 (1.8)	0.16(0.036 to 0.672)	0.006*
Mixed	1 (0.9)	1 (0.9)	1.01(0.064 to 15.931)	>0.999
Severity of delirium, n (%)^a
Mild	4 (3.6)	4 (3.7)	1.01(0.259 to 3.933)	>0.999
Moderate	6 (5.5)	2 (1.8)	0.25(0.055 to 1.161)	0.280
Severe	16 (14.5)	7 (6.4)	0.442(0.189 to 1.031)	0.050
Maximum severity score of delirium measured by CAM-S, M (P25, P75)	3 (2,5)	3 (2,4)		0.718
Time to onset of delirium after surgery, n (%)^b
PD0	9 (8.2)	8 (7.3)	0.90(0.359 to 2.239)	0.816
PD1	3 (2.7)	1 (0.9)	0.34(0.036 to 3.184)	0.622
PD2	5 (4.5)	1 (0.9)	0.20(0.024 to 1.699)	0.212
PD3	9 (8.2)	3 (2.8)	0.34(0.094 to 1.209)	0.135

Notes: Data for the maximum severity score of delirium measured by CAM-S was presented as median (25th percentile, 75th percentile). Other data were presented as number (percentage). *p <0.05, compared with propofol group. ^aWas calculated for patients in the allocated group. ^bWas calculated by the numbers of new onset delirium on the day.

Abbreviations: CI, confidence interval; CAM-S, the method of assessing confusion severity; PD, postoperative day.

Table 5 Effect of Sedation Strategies with Propofol on Postoperative Delirium

Outcome	Propofol
	Lighter Sedation (n = 55)	Heavier Sedation (n = 55)	Risk Ratio (95% CI)	PValue
Any delirium, n (%)	8 (14.5)	18 (32.7)	2.25(1.069 to 4.736)	0.025*
Motoric subtype of delirium, n (%)^a
Hypoactive	1 (1.8)	11 (20.0)	11.0(1.470 to 82.319)	0.002*
Hyperactive	7 (12.7)	6 (10.9)	0.86(0.308 to 2.387)	0.768
Mixed	0	1 (1.8)	–	>0.999
Severity of delirium, n (%)^a
Mild	2 (3.6)	2 (3.6)	1.0(0.146 to 6.848)	>0.999
Moderate	3 (5.5)	3 (5.5)	1.0(0.211 to 4.740)	>0.999
Severe	3 (5.5)	13 (23.6)	4.33(1.307 to 14.365)	0.013*
Maximum severity score of delirium measured by CAM-S, M (P25, P75)	5 (1,6)	3 (2,4)		0.204
Time to onset of delirium after surgery, n (%)^b
PD0	2 (3.6)	7 (12.7)	3.50(0.761 to 16.105)	0.161
PD1	1 (1.8)	2 (3.6)	2.00(0.187 to 21.420)	>0.999
PD2	2 (3.6)	3 (5.5)	1.50(0.261 to 8.630)	>0.999
PD3	3 (5.5)	6 (10.9)	2.00(0.527 to 7.597)	0.489

Note: Data for the maximum severity score of delirium measured by CAM-S was presented as median (25th percentile, 75th percentile). Other data were presented as number (percentage). *p<0.05, compared with propofol lighter sedation group. ^aWas calculated for patients in the allocated group. ^bWas calculated by the numbers of new onset delirium on the day.

Abbreviations: CI, confidence interval; CAM-S, the Confusion Assessment Method Severity; PD, postoperative day.

Table 6 Effect of Sedation Strategies with Dexmedetomidine on Postoperative Delirium

Outcome	Dexmedetomidine
	Lighter Sedation (n = 55)	Heavier Sedation (n = 54)	Risk Ratio (95% CI)	P-value
Any delirium, n (%)	6 (10.9)	7 (13.0)	1.188(0.427 to 3.308)	0.741
Motoric subtype of delirium, n (%)^a
Hypoactive	6 (10.9)	4 (7.4)	0.679(0.203 to 2.273)	0.742
Hyperactive	0	2 (3.7)	-	0.243
Mixed	0	1 (1.9)	-	0.495
Severity of delirium, n (%)^a
Mild	2 (3.6)	2 (3.7)	1.02(0.149 to 6.973)	>0.999
Moderate	0	2 (3.7)	-	0.243
Severe	4 (7.3)	3 (5.6)	0.76(0.179 to 3.254)	>0.999
Maximum severity score of delirium measured by CAM-S, M (P25, P75)	3 (2,4)	4 (2,5)		0.502
Time to onset of delirium after surgery, n (%)^b
PD0	4 (7.3)	4 (7.4)	1.02(0.268 to 3.867)	>0.999
PD1	0	1 (1.9)	-	0.495
PD2	0	1 (1.9)	-	0.495
PD3	2 (3.6)	1 (1.9)	0.51(0.048 to 5.453)	>0.999

Notes: Data for the maximum severity score of delirium measured by CAM-S was presented as median (25th percentile, 75th percentile). Other data were presented as number (percentage). No statistically differences between groups were noted. ^aWas calculated for patients in the allocated group. ^bWas calculated by the numbers of new onset delirium on the day.

Abbreviations: CI, confidence interval; CAM-S, the Confusion Assessment Method Severity, PD, postoperative day.

Schulz KF, Altman DG, Moher D CONSORT statement: updated guidelines for reporting parallel group randomised trials. PLoS Med. 2010;7(3):e1000251.

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