Remimazolam reduces State-Trait Anxiety Inventory-State Scale scores in hemorrhoid surgery with spinal-epidural anesthesia: A randomized trial

Table 1 Baseline demographic and perioperative characteristics, n (%)

	CSE group, n = 30	Combined group, n = 30	P value
Age (years)	43.07 ± 12.84	41.03 ± 12.02	0.511
Gender			0.439
Female	16 (53.33)	13 (43.33)
Male	14 (46.67)	17 (56.67)
Weight (kg)	62.73 ± 12.68	64.00 ± 13.52	0.699
Height (cm)	164.13 ± 7.92	166.07 ± 9.34	0.348
ASA classification			0.818
I	50 (90.9)	47 (92.1)
II	5 (9.1)	4 (7.9)
Anesthesia induction to incision time (minutes)	15.00 (15-20)	15.00 (15-20)	0.756
Surgical duration (minutes)	49.23 ± 20.15	53.67 ± 23.88	0.312
Post-surgical exit time from operating room (minutes)	10.00 (5-15)	10.00 (10-10)	0.234
Hospital stay (days)	5.93 ± 2.26	5.67 ± 2.96	0.149

ASA: American Society of Anesthesiologists; CSE: Combined spinal-epidural.

Table 2 Comprehensive mixed-effects model results for State-Trait Anxiety Inventory- State scale scores and hemodynamic variables

Variable	Effect	Fdf1, df2 value	P value	Geisser-Greenhouse's epsilon
STAI-S	Time	F1.71, 98.99 = 83.56	< 0.001a	0.8534
	Group	F1, 58 = 201.4	< 0.001a
	Time × group	F2, 116 = 110.0	< 0.001a
SBP	Time	F3.28, 190.5 = 10.04	< 0.001a	0.8210
	Group	F1, 58 = 4.34	0.042a
	Time × group	F4, 232 = 2.44	0.048a
DBP	Time	F2.87, 166.5 = 3.96	0.010a	0.7176
	Group	F1, 58 = 0.75	0.391
	Time × group	F4, 232 = 0.26	0.901
HR	Time	F2.72, 157.7 = 0.85	0.462	0.6796
	Group	F1, 58 = 0.07	0.796
	Time × group	F4, 232 = 1.06	0.380

^aP < 0.05.

P values were calculated using a two-way mixed-effects ANOVA. F_{df1, df2}: F statistics with df1 (degrees of freedom for the effect) and df2 (degrees of freedom for error), sphericity was assessed using Mauchly’s test, and the Greenhouse - Geisser correction was applied where sphericity was violated. Time: Main effect of time points. Group: Main effect of experimental groups. Time × Group: Interaction effect between time points and experimental groups. STAI-S: State-Trait Anxiety Inventory-State scale scores; SBP: Systolic blood pressure (mmHg); DBP: Diastolic blood pressure (mmHg); HR: Heart rate (beats/minute).

Table 3 Comparison of State-Trait Anxiety Inventory-State scale scores and hemodynamic variables across time points

Variable	Time point	CSE group, n = 30	Combined group, n = 30	Mean difference (95%CI)	Adjusted P value
STAI-S	TS0	51.93	52.80	-0.87 (-3.143-1.409)	> 0.999
	TS1	54.03	28.80	25.23 (21.24-29.23)	< 0.001a
	TS2	54.53	45.07	9.47 (6.29-12.64)	< 0.001a
SBP	T0	126.0	121.4	4.60 (-7.92-17.12)	> 0.999
	T1	125.6	120.0	5.63 (-7.71-18.97)	> 0.999
	T2	128.8	114.7	14.17 (0.77-27.57)	0.033a
	T3	120.1	111.2	8.87 (-3.18-20.91)	0.273
	T4	121.0	111.4	9.60 (-0.89-20.09)	0.089
DBP	T0	72.80	70.87	1.93 (-8.38-12.25)	> 0.999
	T1	73.70	71.93	1.77 (-10.39-13.92)	> 0.999
	T2	72.93	68.97	3.97 (-6.38-14.31)	> 0.999
	T3	70.60	67.20	3.40 (-5.92-12.71)	> 0.999
	T4	70.07	66.67	3.40 (-4.02-10.82)	> 0.999
HR	T0	76.94	76.28	1.967 (-5.86-9.79)	> 0.999
	T1	76.67	77.00	-0.33 (-9.33-8.66)	> 0.999
	T2	78.70	75.53	3.17 (-6.65-12.98)	> 0.999
	T3	77.17	76.00	1.17 (-6.41-8.75)	> 0.999
	T4	73.60	76.27	-2.67 (-11.05-5.72)	> 0.999

^aP < 0.05.

P values were calculated using post-hoc analysis Bonferroni correction, multiple comparisons test was conducted to assess intergroup differences at each time point, with effect sizes expressed as mean differences (95%CI). STAI-S: State: Trait Anxiety Inventory - State scale scores; SBP: Systolic blood pressure (mmHg); DBP: Diastolic blood pressure (mmHg); HR: Heart rate (beats/minute); CSE: Combined spinal-epidural.

Table 4 Comparison of Ramsay sedation scores at different postoperative time points

Time point	CSE group, n = 30	Combined group, n = 30	Median difference (95%CI)	P value
T0	2.00 (2.00-2.00)	2.00 (2.00-2.00)	0.00 (0.00-0.00)	0.492
T1	2.00 (2.00-2.00)	2.00 (2.00-2.00)	0.00 (0.00-0.00)	0.492
T2	2.00 (2.00-2.00)	5.00 (5.00-5.00)	3.00 (3.00-3.00)	< 0.001a
T3	2.00 (2.00-2.00)	5.00 (5.00-5.00)	3.00 (3.00-3.00)	< 0.001a
T4	2.00 (2.00-2.00)	2.00 (2.00-2.00)	0.00 (0.00-0.00)	> 0.999

^aP < 0.05.

P values were calculated using the Mann-Whitney U test, with Hodges-Lehmann estimated median differences (95%CI). T1 was the time prior to positioning. T2 was the time at the commencement of surgery. T3 was 10 minutes after the start of the surgical procedure. T4 was the time when patients were discharged from the operating room. CSE: Combined spinal-epidural.