Table 3.

Efficacy outcomes

	Remimazolam group group (n = 54)	Routine group (n = 54)	Estimated effect size (95% CI)	Pa
Primary outcome
RCSQ at surgery night, scoreb
Intention-to-treat	59 (28, 75)	53 (28, 67)	MD = 6 (− 6, 16)	0.315
Per protocol	62 (27, 77) (n = 52)	52 (28, 66) (n = 53)	MD = 6 (− 4, 16)	0.211
Secondary outcomes
RCSQ after surgery, scoreb
First night	69 (56, 85)	70 (54, 80)	MD = 2 (− 4, 10)	0.472
Second night	80 (68, 87)	76 (64, 84)	MD = 4 (0, 10)	0.066
NRS pain intensity at rest, scorec
First day	1 (0, 3)	0 (0, 2)	MD = 0 (0, 1)	0.114
Second day	1 (0, 3)	1 (0, 2)	MD = 0 (0, 1)	0.206
Third day	1 (0, 3)	0 (0, 2)	MD = 0 (0, 0)	0.313
Postoperative nausea and vomiting, n	10 (18.5%)	7 (13.0%)	RR = 1.43 (0.59, 3.48)	0.428
Major complications, nd	1 (1.9%)	3 (5.6%)	RR = 0.33 (0.04, 3.11)	0.618
Length of in-hospital stay after surgery, day	7 (6, 10)	7 (7, 11)	HR = 1.16 (0.79, 1.70)	0.449

Data are presented as median (interquartile range) or number (%)

MD, median difference or mean difference; HR, hazard ratio; RR, relative risk; RCSQ, Richards Campbell Sleep Questionnaire; NRS, Numeric Rating Scale

^aCalculated as BIS-guided group versus or minus routine group

^bThe RCSQ involves five domains including sleep depth, sleep latency, awakenings, returning to sleep, and sleep quality. Overall RCSQ sleep score is defined as the mean value of above five domains and it ranges from 0 to 100 with higher score for better sleep

^cPain intensity at rest was assessed by numeric rating scale (11-point scale, 0 for no pain and 10 for the worst pain)

^dComplications requiring medical interventions (i.e., Clavien–Dindo classification 2 and above) within postoperative 30 days. One patient in BIS-guided group suffered lower limbs venous thrombosis. Three patients in routine group suffered complications including cardiac injury, new-onset atrial fibrillation, and urinary tract infection