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Background <p>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.</p> Methods <p>Patients aged 20 to 45 years with a BMI of 18.5 to 27.9&#xa0;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&#xa0;µg/kg, followed by intravenous remimazolam after 2&#xa0;min. The initial remimazolam dose was set at 0.2&#xa0;mg/kg and adjusted by 0.02&#xa0;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 &lt; 2 within 5&#xa0;min. Adverse events were recorded. The estimation of ED<sub>50</sub>, ED<sub>90</sub> and ED<sub>95</sub> with a 95% confidence interval (CI) was conducted by probit regression.</p> Results <p>The ED<sub>50</sub>, ED<sub>90</sub> and ED<sub>95</sub> of remimazolam for successful sedation in combination with sufentanil induction were 0.205&#xa0;mg/kg (95% CI 0.190–0.222), 0.232&#xa0;mg/kg (95% CI 0.218–0.311) and 0.240&#xa0;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.</p> Conclusions <p>In summary, when combined with 0.1&#xa0;µg/kg of sufentanil, the ED<sub>50</sub>, ED<sub>90</sub> and ED<sub>95</sub> values of remimazolam for effective sedation during transvaginal oocyte retrieval, were 0.205&#xa0;mg/kg, 0.232&#xa0;mg/kg and 0.240&#xa0;mg/kg, respectively, with a low occurrence of adverse events.</p> Trial registration <p>The study protocol was registered at <a href="http://www.chictr.org.cn">http://www.chictr.org.cn</a> (registration number: ChiCTR2400082576 on 01/04/2024).</p>

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

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  • 发表日期：

    2025年11月18日

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  • Yanfei Lu,
  • Gongchen Duan,
  • Jiafeng Fu,
  • Foquan Luo,
  • Bin Wang,
  • Junhui Lang

摘要

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 ED50, ED90 and ED95 with a 95% confidence interval (CI) was conducted by probit regression.

Results

The ED50, ED90 and ED95 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 ED50, ED90 and ED95 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).