Objective <p>To determine the effective dose of ciprofol in combination with remifentanil for successful laryngeal mask airway (LMA) placement without the use of muscle relaxants.</p> Design <p>A two-phase, biased-coin, up-and-down sequential allocation trial.</p> Setting <p>Single tertiary hospital; general anesthesia induction.</p> Patients <p>106 American Society of Anesthesiologists (ASA) physical status I–II adult patients (aged 18–75 years) scheduled for elective surgery under LMA anesthesia.</p> Interventions <p>• <b>Phase 1</b>: Ciprofol was fixed at 0.4 mg/kg, while remifentanil doses were adjusted using a biased-coin design to estimate the median effective dose (ED₅₀) and 95% effective dose (ED₉₅).</p> <p>• <b>Phase 2</b>: Remifentanil was fixed at the ED₅₀ determined in Phase 1, and ciprofol doses were similarly titrated to determine its effective dose.</p> Measurements <p>Successful LMA placement was defined as the absence of coughing or gagging, along with an effective seal (air leak pressure &gt; 20 cmH₂O). Secondary outcomes included hemodynamic fluctuations (ΔMAP &gt; 20%), apnea, and injection pain.</p> Results <p>The ED₅₀ of remifentanil was 0.7 μg/kg when combined with ciprofol 0.34 mg/kg. Adverse events included hypotension (12.7%) and bradycardia (9.5%).</p> Conclusions <p>The combination of ciprofol 0.34 mg/kg and remifentanil 0.7 μg/kg provides effective conditions for LMA placement without muscle relaxants. This regimen reduces opioid requirements and may promote faster recovery.</p> Trial registration <p>Chinese Clinical Trial Registry ChiCTR2200062686; registered on August 15, 2022 (retrospectively registered).</p>

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Optimal dose of ciprofol combined with remifentanil for laryngeal mask placement without muscle relaxant: a biased-coin up-and-down sequential allocation trial

  • Xiaojian Lu,
  • Hongwei Wang,
  • Chenrong Bao,
  • Ying Wang,
  • Yan Luo

摘要

Objective

To determine the effective dose of ciprofol in combination with remifentanil for successful laryngeal mask airway (LMA) placement without the use of muscle relaxants.

Design

A two-phase, biased-coin, up-and-down sequential allocation trial.

Setting

Single tertiary hospital; general anesthesia induction.

Patients

106 American Society of Anesthesiologists (ASA) physical status I–II adult patients (aged 18–75 years) scheduled for elective surgery under LMA anesthesia.

Interventions

Phase 1: Ciprofol was fixed at 0.4 mg/kg, while remifentanil doses were adjusted using a biased-coin design to estimate the median effective dose (ED₅₀) and 95% effective dose (ED₉₅).

Phase 2: Remifentanil was fixed at the ED₅₀ determined in Phase 1, and ciprofol doses were similarly titrated to determine its effective dose.

Measurements

Successful LMA placement was defined as the absence of coughing or gagging, along with an effective seal (air leak pressure > 20 cmH₂O). Secondary outcomes included hemodynamic fluctuations (ΔMAP > 20%), apnea, and injection pain.

Results

The ED₅₀ of remifentanil was 0.7 μg/kg when combined with ciprofol 0.34 mg/kg. Adverse events included hypotension (12.7%) and bradycardia (9.5%).

Conclusions

The combination of ciprofol 0.34 mg/kg and remifentanil 0.7 μg/kg provides effective conditions for LMA placement without muscle relaxants. This regimen reduces opioid requirements and may promote faster recovery.

Trial registration

Chinese Clinical Trial Registry ChiCTR2200062686; registered on August 15, 2022 (retrospectively registered).