Efficacy and Safety of Remimazolam Besylate Versus Propofol During Hysteroscopy

Single-centre Randomized Controlled Trial

Xiaoqiang Zhang; Shuang Li and Jing Liu

BMC Anesthesiol. 2021;21(156)

Background

Hysteroscopy is one of the most common outpatient procedures in the diagnosis and treatment of endometrial and other intrauterine diseases. Most patients require anaesthetic intervention because they cannot tolerate the intense pain of cervical dilatation and endometrial curettage.^[1–3]

The commonly used anesthetic methods used for hysteroscopic surgery include propofol combined with opioids, propofol combined with dexmedetomidine, paracervical block, and local anaesthesia.^[4–6] Among these, propofol combined with opioids is still the most commonly used method to control pain during hysteroscopy.^[7] However, propofol has a high incidence of adverse events, such as injection pain, postoperative dizziness, and low pulse oximetry (SpO₂).

Remimazolam besylate is a newer benzodiazepine with characteristics of quick onset of effects, short maintenance and recovery times. It does not accumulate in tissues; metabolism is independent of liver and kidney function without any major side effect. Furthermore, opioids can have a sedative effect in some endoscopic examinations.^[8–10]

This trial was conducted to confirm the efficacy and safety of remimazolam besylate versus propofol during hysteroscopy.

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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