Efficacy and Safety of Remimazolam Besylate Versus Propofol During Hysteroscopy

Single-centre Randomized Controlled Trial

Xiaoqiang Zhang; Shuang Li and Jing Liu

Disclosures

BMC Anesthesiol. 2021;21(156) 

In This Article

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.

Figure 2.

Mean arterial pressure (MAP)-time graph

Figure 3.

Heart rate (HR)-time graph

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).

Figure 5.

MOAA/S-time graph

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