The effective dose of remimazolam in combination with sufentanil for sedation during transvaginal oocyte retrieval: an up-and-down sequential allocation trial

瑞米唑仑联合舒芬太尼用于经阴道取卵术镇静的有效剂量:一项递增递减序贯分配试验

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Abstract

BACKGROUND: The potential adverse effects of propofol on fertilization outcomes have raised concerns among patients undergoing anesthesia for oocyte retrieval. Remimazolam is a new type of ultra-short-acting benzodiazepine. This study aimed to find the effective dose of remimazolam in combination with sufentanil for sedation in oocyte retrieval. METHODS: Patients aged 20 to 45 years with a BMI of 18.5 to 27.9 kg/m² and ASA physical status I or II, undergoing transvaginal oocyte retrieval, were recruited. All patients were administered intravenous sufentanil at a dose of 0.1 µg/kg, followed by intravenous remimazolam after 2 min. The initial remimazolam dose was set at 0.2 mg/kg and adjusted by 0.02 mg/kg according to the modified Dixon sequential method. The primary endpoint was successful sedation, defined as a Modified Observer’s Assessment of Alertness/Sedation (MOAA/S) score ≤ 1 and an Intraoperative Movement Scale (IOMS) score < 2 within 5 min. Adverse events were recorded. The estimation of ED(50), ED(90) and ED(95) with a 95% confidence interval (CI) was conducted by probit regression. RESULTS: The ED(50), ED(90) and ED(95) of remimazolam for successful sedation in combination with sufentanil induction were 0.205 mg/kg (95% CI 0.190–0.222), 0.232 mg/kg (95% CI 0.218–0.311) and 0.240 mg/kg (95% CI 0.223–0.339), respectively. There were three cases of hypoxemia, with no other adverse events reported, including injection pain, hypotension, bradycardia, dizziness, nausea, vomiting, or delayed emergence. CONCLUSIONS: In summary, when combined with 0.1 µg/kg of sufentanil, the ED(50), ED(90) and ED(95) values of remimazolam for effective sedation during transvaginal oocyte retrieval, were 0.205 mg/kg, 0.232 mg/kg and 0.240 mg/kg, respectively, with a low occurrence of adverse events. TRIAL REGISTRATION: The study protocol was registered at http://www.chictr.org.cn (registration number: ChiCTR2400082576 on 01/04/2024).

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