ED50 and ED95 of Remimazolam Tosilate Combined with Different Doses of Fentanyl in Elderly Patients for Painless Gastroscopy

Figures & data

Table 1 Demographic Characteristics for Three Groups

	Group F1 (n=18)	Group F2 (n=17)	Group F3 (n=16)	P value
Age(y)	71.28±3.10	71.65±4.03	72.13±2.94	0.112
Sex (M/F)	10/8	11/6	8/8	0.689
Height(cm)	159.28±6.59	158.24±10.35	159.56±8.26	0.516
Weight(kg)	61.39±7.19	58.06±8.56	60.06±8.98	0.657
BMI (kg/m^2)	24.21±2.66	23.49±5.48	23.58±2.99	0.679
ASA (II/III)	15/3	14/3	14/2	0.876

Notes: Data are presented as the mean ± SD or as the number of patients, as appropriate.

Abbreviations: M, male; F, female; BMI, body mass index; ASA, American Society of Anesthesiologists.

Figure 1 CONSORT flow diagram.

Abbreviation: CONSORT, Consolidated Standards of Reporting Trials.

Figure 2 Individual response to the stimulus of gastroscopy placement in the study groups. Positive response to gastroscopy placement are marked with ●, and negative reaction to gastroscopy placement are marked with ○. The doses of fentanyl in group F₁ were 0.5ug/kg (A), in group F₂ were 1.0ug/kg (B), in group F₃ were 1.5 μg/kg (C), respectively. To get six crossovers, 18, 17 and 16 patients were included individually in groups F₁, F₂, F₃.

Table 2 ED50 and ED95 of Remimazolam Tosilate and Its 95% CI for the Three Groups

	Group F1 (n=18)	Group F2 (n=17)	Group F3 (n=16)
ED50 (mg/kg)	0.258 (0.249–0.266)	0.162 (0.153–0.171)^a	0.095 (0.088–0.108)^ab
ED95 (mg/kg)	0.272 (0.264–0.295)	0.175 (0.167–0.200)	0.109 (0.101–0.135)

Notes: ^aP < 0.05 versus Group F₁. ^bP < 0.05 versus Group F₂.

Abbreviations: ED50, median effective dose; ED95, 95% effective dose; CI, confidence intervals.

Table 3 SBP, DBP, HR, SPO2 at Different Time Points for Three Groups

	Group F1 (n=18)	Group F2 (n=17)	Group F3 (n=16)	P value
SBP (mmHg)
T0	120.24±10.33	126.45±13.34	121.52±15.73	0.329
T1	105.92±11.34	112.71±13.92	118.54±14.23	0.119
T2	97.25±7.86	101.63±10.34	100.82±8.64	0.227
T3	99.72±7.43	101.52±10.34	99.72±9.04	0.949
T4	100.73±10.45	104.72±12.74	106.92±13.91	0.372
DBP (mmHg)
T0	72.72±11.63	66.05±10.92	69.51±11.62	0.226
T1	62.32±12.13	61.33±11.94	69.14±11.42	0.161
T2	56.83±7.04	56.35±4.57	61.83±9.85	0.082
T3	59.14±9.15	55.65±8.36	62.14±8.65	0.112
T4	66.82±9.74	63.25±9.36	65.45±10.35	0.257
MAP (mmHg)
T0	87.25±8.77	84.55±10.71	86.75±10.29	0.714
T1	76.27±12.48	77.72±11.44	85.51±13.72	0.082
T2	69.27±6.55	70.72±7.13	79.93±12.94	0.082
T3	71.33±6.05	70.14±8.62	74.28±7.33	0.173
T4	75.33±7.84	78.52±10.54	80.62±11.43	0.576
HR (bpm)
T0	74.12±10.03	73.45±7.52	75.82±12.23	0.776
T1	70.72±9.33	72.24±8.82	76.14±11.82	0.283
T2	74.32±8.04	70.23±9.05	69.52±12.75	0.965
T3	77.25±8.44	69.73±9.64	70.12±11.93	0.962
T4	70.52±8.43	71.52±6.93	73.24±9.22	0.368

Notes: Data are presented as mean ± SD or number. Significance for post hoc analysis after analysis of variance (ANOVA) was corrected with Bonferroni’s method. T₀ is the time before the administration of fentanyl, T₁ is the time when the endoscope was inserted into the pharyngeal cavity, T₂ is the time when the endoscope was pulled out of the pharyngeal cavity, and T₃ is the time of awakening from anesthesia. T₄ is the time away from recovery room.

Abbreviations: SBP, Systolic blood pressure; DBP, diastolic blood pressure; MAP, Average arterial blood pressure; HR, heart rate.

Table 4 Intraoperative and Postoperative Data

	Group F1 (n=18)	Group F2 (n=17)	Group F3 (n=16)	P value
Total dosage of remimazolam tosilate (mg)	17.46 ±1.85	11.23 ±1.49^a	7.51±1.73^ab	<0.001
Duration of Gastroscopy(min)	7.25 (7.00–8.10)	8.0 (7.00–8.20)	8.75 (8.00–9.00)	0.056
Time of consciousness recovery (min)	6.33±1.74	5.94±2.10	5.75±1.48	0.629
Length of recovery room stay (min)	31.11±9.57	30.25 ±9.16	30.04 ±7.53	0.751
Hypoxemia	0 (0.00%)	0 (0.00%)	0 (0.00%)	1.0
Injection pain	5 (27.78%)	1 (5.88%)^a	0 (0.00%)^a	0.038
Hiccup	7 (38.89%)	4 (23.53%)	3 (18.75%)	0.423
Hypotension	6 (33.33%)	4 (23.53%)	0 (0.00%)^a	0.037
Bradycardia	0 (0.00%)	0 (0.00%)	0 (0.00%)	1.0
Intraoperative awareness	0 (0.00%)	0 (0.00%)	0 (0.00%)	1.0
Postoperative nausea and vomiting	2 (11.11%)	1 (5.88%)	1 (5.88%)	1.0
Postoperative delirium	0 (0.00%)	0 (0.00%)	0 (0.00%)	1.0
Postoperative dizziness	0 (0.00%)	0 (0.00%)	0 (0.00%)	1.0

Notes: Data are presented as the mean ± SD, median (25th to 75th percentiles) or as the number (proportion) as appropriate. ^aP < 0.05 versus Group F₁. ^bP < 0.05 versus Group F₂.

Data Sharing Statement

The data supporting the study findings are available from the corresponding author upon request.