Etomidate Combined with Propofol versus Remimazolam for Sedation in Elderly Patients During Gastrointestinal Endoscopy: A Randomized Prospective Clinical Trial

Figures & data

Table 1 Basic Characteristics of the Study Groups

	EP Group (n=60)	R Group (n=60)	P value
Type of procedure (Gastroscopy/ Colonoscopy/ Gastrointestinal endoscopy)	4/5/51	1/7/52	0.343
Sex (male/female)	24/36	22/38	0.851
Age	66.2±3.7	64.9±4.2	0.078
Body height (cm)	165.7±8.6	164.8±8.0	0.728
Body weight (kg)	65.6±10.0	65.8±11.0	0.927
BMI (kg/m^2)	23.8±2.9	24.1±2.7	0.755
ASA classification (grade I/II)	11/49	16/44	0.382

Abbreviations: BMI, body mass index; ASA, The American Society of Anesthesiologists physical status.

Table 2 Comparison of Primary Outcomes

	EP Group (n=60)	R Group (n=60)	95% CI	P value
Induction Time (minute)	1.15±0.38	1.50±0.63	−0.54, −0.17	<0.001
Total procedure time (minute)	19.02±6.64	19.30±7.12	−2.77, 2.21	0.831
Voluntary eye-opening time (minute)	10.16±4.06	10.69±3.91	−1.97, 0.92	0.231
Recovery time (minute)	12.72±3.72	13.08±4.06	−1.77, 1.04	0.668
Observation time in the PACU (minute)	17.40±2.08	15.17±2.46	1.41, 3.06	<0.001
Mini-cog score	2.58±0.53	2.83±0.38	−0.42, −0.08	0.004
Consumption of sedatives, mL	9.74±2.07	9.93±2.02	−0.93, 0.55	0.768
Consumption of analgesics, µg	32.22±7.46	34.20±7.09	−4.61, 0.65	0.130
Consumption of analgesics (µg/kg/min)	0.027+0.01	0.031+0,01	−0.01, 0.00	0.199
Pain score	0.18±0.47	0.05±0.22	0.00, 0.27	0.065
Satisfaction score	9.83±0.42	9.93±0.31	−0.23, 0.03	0.075

Table 3 Comparison of Adverse Effects

	EP Group (n=60)	R Group (n=60)	Total (n=120)	P value
Hiccups (n, %)	0	8 (13.3%)	8 (6.7%)	0.003
Hypoxia (n, %)	3 (5.0%)	1 (1.7%)	4 (3.3%)	0.310
Depression of respiration (n, %)	6 (10.0%)	1 (1.7%)	7 (5.8%)	0.051
Tongue falling (n, %)	2 (3.3%)	1 (1.7%)	3 (2.5%)	0.559
Total respiratory-related adverse events (n, %)	11 (18.3%)	3 (5.0%)	14 (11.7%)	0.047
Choking cough (n, %)	0 (0.0%)	3 (5.0%)	3 (2.5%)	0.080
Movement of the body (n, %)	2 (3.3%)	1 (1.7%)	3 (2.5%)	0.559
Low blood pressure (n, %)	22 (36.7%)	24 (40%)	46 (38.33%)	0.851
Nausea (n, %)	1 (1.7%)	1 (1.7%)	2 (1.7%)	1
Dizziness (n, %)	1 (1.7%)	0 (0%)	1 (0.8%)	1

Table 4 Comparison of Follow-Up Questionnaires Before Discharge

Variate	Description Statistic	EP Group (n=60)	R Group (n=60)	P value
How was the sedation for your procedure?				<0.001
	Excellent	7 (11.7%)	40 (66.7%)
	Good	43 (71.7%)	19 (31.7%)
	Fair Poor	10 (16.7%)	1 (1.7%)
Do you think you needed any adjustment of your sedation?				0.220
	Just right	58 (96.7%)	59 (98.3%)
	Needed more	2 (3.3%)	0 (0.0%)
	Needed less	0 (0.0%)	1 (1.7%)
Do you remember the start of the procedure?				1
	No	57 (95.0%)	57 (95.0%)
	Yes	3 (5.0%)	3 (5.0%)
Do you remember being awake during the procedure?				0.662
	No	45 (75.0%)	48 (80.0%)
	Yes	15 (25.0%)	12 (20.0%)
Do you remember the end of the procedure when the instrument was removed?				1
	No	29 (48.3%)	30 (50.0%)
	Yes	31 (57.7%)	30 (50.0%)

Table 5 Comparison of Follow-Up Telephone Questionnaire 24-Hour After Procedure

Variate	Description Statistic	EP Group (n=59)	R Group (n=58)	P value
How was the sedation for your procedure?				<0.001
	Excellent	12 (20.3%)	37 (63.8%)
	Good	39 (66.1%)	21 (36.2%)
	Fair Poor	8 (13.6%)	0 (0.0%)
Do you think you needed any adjustment of your sedation?				0.215
	Just right	54 (91.5%)	57 (98.3%)
	Needed more	2 (3.4%)	0 (0.0%)
	Needed less	3 (5.1%)	1 (1.7%)
Do you remember the start of the procedure?				0.986
	No	57 (96.6%)	56 (96.6%)
	Yes	2 (3.4%)	2 (3.4%)
Do you remember being awake during the procedure?				0.479
	No	54 (91.5%)	55 (94.8%)
	Yes	5 (8.5%)	3 (5.2%)
Do you remember the end of the procedure when the instrument was removed?				0.008
	No	36 (61.0%)	49 (84.5%)
	Yes	23 (39.0%)	9 (15.5%)
Do you think that the rest of your day was impaired by the sedation?				0.027
	Severe	0	0
	No	41 (69.5%)	51 (87.9%)
	Yes	18 (30.5%)	7 (12.0%)
Did you require additional sleep during the daytime after the procedure?				0.253
	No need or change from usual	50 (84.7%)	54 (93.1%)
	Needed compared to the usual	9 (15.3%)	4 (6.9%)

Figure 1 Study design: summary of inclusion and exclusion criteria of study population.

Figure 2 Comparison of MOAA/S score. The MOAA/S score of the R group was higher than that of the EP group at first 2min after administration (P< 0.05).

Figure 3 Comparison of SpO₂ and PetCO_2. There was no significant difference in SPO₂ between the two groups at each time point (P>0.05). Compared with the baseline value T0, PetCO₂ decreased within 1–10 min after the first dose in both groups (P <0.05) and decreased to the lowest level approximately 3 min after administration.

Figure 4 Comparison of respiratory rates. In both groups, respiratory rates decreased from 1 to 5 min after administration of the drug compared with baseline. It then returned to baseline levels. The RR was lower in the EP group than in the R group at 3 min after administration (P<0.05).

Figure 5 Comparison of heart rates. The heart rate of group R was higher than that of group EP at 2, 3 and 5 min after administration (P < 0.05).

Figure 6 Comparison of blood pressure. Systolic blood pressure in EP group was higher than that in R group at 15 min and 25 min after administration (P < 0.05). There was no significant difference in diastolic blood pressure between the two groups (P>0.05).

Data Sharing Statement

The datasets generated and/or analyzed during the current study are not publicly available, but are available from the corresponding author upon reasonable request.