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)

Conclusions

Remimazolam besylate proves to be a safer alternative for anesthesia during hysteroscopy. Meanwhile, adverse events caused by propofol, such as low SpO₂ and injection pain, are largely avoided. This study was a single centre study, and multicentre studies are recommended to reach more relevant conclusions.

1 2 3 4 5 6

Next Section

Acknowledgements
Not applicable.

Funding
This study was self-financed.

Availability of data and materials
The datasets generated and analysed during the current study are not publicly available due to institutional restrictions but are available from the corresponding author on reasonable request.

Declarations
Ethics approval and consent to participate
This study was approved by the Clinical Research Ethics Committee of Mengcheng County No. 1 People's Hospital (2020MYL20003) and registered at https://www.chictr.org.cn (15/09/2020, ChiCTR-2000038252). The study protocol followed the CONSORT guidelines. The study protocol was performed in the relevant guidelines. Written informed consent was obtained from all patients.

Consent for publication
Not applicable.

Competing interests
All authors declare that they have no conflicts of interest.

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