Recovery and discharge time between remimazolam tosylate and propofol in hysteroscopy anesthesia: a randomized controlled study

Abstract

Background Hysteroscopy is considered the gold standard for the evaluation and treatment of uterine and endometrial lesions, but the operation is accompanied by severe pain, so it needs to be performed under anesthesia. Currently, a new sedative drug, remimazolam tosilate, can be used in digestive endoscopy and bronchoscopy. We will study its effect on hysteroscopy and its impact on patient recovery time and hospital discharge time. Methods Ninety-five patients undergoing hysteroscopy were randomly divided into two groups and received an initial dose of 0.2 mg/kg remimazolam tosilate (R group) and an initial dose of 2 mg/kg propofol (P group) as anesthetics during the examination. The primary end point was anesthesia recovery time (the time required for the patient's MOAA/S score to reach 5 from the cessation of drug use) and hospital discharge time (the time required for the patient's PADS score to reach 9 from the cessation of drug use). Secondary endpoints were first-dose sedation success rate, incidence of hypotension, and injection pain. Results Age(P = 0.825), height(P = 0.174), weight(P = 0.667) and ASA grade (P = 0.972) were not significantly different between the two groups. The recovery time in the R group was significantly shorter than that in the P group (P = 0.019), and the data kurtosis in the R group was higher than that in the P group (1.19 vs -0.56), but there was no significant difference in the time to hospital discharge (P = 0.696). There was no significant difference in the success rate of the first dose of sedation between the two groups (P = 0.362), but the incidence of hypotension during anesthesia (P = 0.001) and the incidence of injection pain (P = 0.001) in the R group was significantly lower than those in P group. Conclusions Remimazolam tosilate is suitable for hysteroscopy anesthesia and can reduce intraoperative hypotension and injection pain during the examination, a more optimal dosage or target-controlled infusion model still needs to be further explored.

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

Chictr.org?Registration number:ChiCTR2100048738

Funding Statement

The author(s) received no specific funding for this work.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

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The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

This study approved by the Medical Research Ethics Committee of Shunde Women and Children's Hospital of Guangdong Medical University (Maternal and Child Health Hospital of Shunde Foshan) (registration number:2020055)

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

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Data Availability

All relevant data are within the manuscript and its Supporting Information files.

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