Remimazolam Besylate vs. Propofol During Hysteroscopy

Results

The study population comprised 82 randomly coded patients in Group R (n = 41) and Group P (n = 41) (Figure 1).

Figure 1.

Flow diagram of the study

Demographic Data and Surgical Characteristics

The demographic characteristics of the patients and surgical characteristics are given in Table 2. The characteristics were similar in both groups.

The operative durations were similar in the two groups (p > 0.05). The awakening time of Group R (199.0 ± 79.9 s) was significantly longer than that of Group P (59.7 ± 1.2 s) (p < 0.05). However, the PACU length of stay in Group R (5.44 ± 1.0 min) was significantly shorter than that in Group P (6.3 ± 1.9 min) (p < 0.05). The total remifentanil dose was not significantly different among the two groups (p > 0.05). The supplemental remimazolam dose was 10.8 ± 4.0 mg.

Adverse Events

Adverse events occurred on 6 (3.7%) occasions in group R and 60 (36.6%) occasions in group P (p < 0.001), with no serious adverse events or deaths occurring in the two groups (Table 2). The incidence of injection pain in Group P was much higher than that in Group R (80.5% vs 2.4%, p < 0.001). The incidence of other adverse events, such as low SpO₂, bradycardia, and hypotension in Group R was lower than that in Group P (p < 0.05). During the examination, 15 and 20 patients in Group R and Group P, respectively, exhibited slight body movement such as visible bending of the hand or movement of the head, but this did not interfere with the operation or cause dropout from the research (p > 0.05).

Changes in Circulation

Compared with T0, the MAP, HR, and SpO₂ at T1–4 were all reduced in the two groups (all p < 0.05), but all values were within the clinically normal range (Figures 2, 3, and 4). During the anaesthesia, only one patient in Group P had bradycardia (HR < 60 bpm), but this condition improved rapidly. Compared to Group P, Group R showed less fluctuation in the MAP, HR, and SpO₂.

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Figure 2.

Mean arterial pressure (MAP)-time graph

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Figure 3.

Heart rate (HR)-time graph

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Figure 4.

SpO₂-time graph

MOAA/S Score

In this study, the rate of anaesthesia success in the two groups was 100%, and the patients in the two groups did not require any other medications or withdraw from the study due to insufficient anaesthetic depth. The MOAA/S scores in the two groups during hysteroscopy indicated that the depth of anaesthesia was adequate and effective (Figure 5).

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Figure 5.

MOAA/S-time graph

Table 1. The definition and incidence of adverse events
Adverse events	Definitions	Group R (N = 41)	Group P (n = 41)	p value
Injection pain	'Subjective' assessment, patients verbally reported their pain by themselves after the first injection	1 (2.4%)	33 (80.5%)	< 0.001
Low SpO₂	Intraoperative SpO₂ ≤ 95%	4 (9.8%)	21 (51.2%)	< 0.001
Bradycardia	Intraoperative HR < 55 bpm	0 (0.0%)	1 (2.4%)	0.314
Hypotension	Intraoperative SBP<90 mmHg	1 (2.4%)	5 (12.2%)	0.090
Total incidence of adverse events		6 (3.7%)	60 (36.6%)	< 0.001
Postoperative dizziness	Appeared while patients stayed in the postanaesthesia care unit (PACU)	0 (0.0%)	10 (24.4%)	< 0.001
Body movement	Visible hand bending or head movement	15 (36.6%)	20 (48.8%)	0.264

Note: Values are presented as n (%); HR-heart rate; SBP-systolic blood pressure

Table 2. Demographic characteristics and clinical data for each group
	Group R (n = 41)	Group P (n = 41)
Age (years)	43.8 ± 8.0	45.2 ± 7.0
Height (cm)	159.6 ± 5.2	160.0 ± 4.9
Weight (kg)	62.8 ± 7.6	61.6 ± 8.2
BMI (kg/m²)	24.7 ± 2.7	24.1 ± 2.8
ASA (I/II) (n)	28/13	34/7
Duration of operation (min)	13.2 ± 4.2	12.6 ± 4.7
Duration of awakening (s)	199.0 ± 79.9	59.7 ± 1.2
PACU length of stay (min)	5.44 ± 1.0	6.3 ± 1.9
Total remimazolam (mg/kg)	0.4 ± 0.1	–
Total propofol (mg/kg)	–	2.5 ± 0.6
Total remifentanil (μg)	75.7 ± 15.2	73.2 ± 22.2