Optimal dose of ciprofol combined with remifentanil for laryngeal mask placement without muscle relaxant: a biased-coin up-and-down sequential allocation trial
摘要
To determine the effective dose of ciprofol in combination with remifentanil for successful laryngeal mask airway (LMA) placement without the use of muscle relaxants.
DesignA two-phase, biased-coin, up-and-down sequential allocation trial.
SettingSingle tertiary hospital; general anesthesia induction.
Patients106 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.
MeasurementsSuccessful 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.
ResultsThe 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%).
ConclusionsThe 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 registrationChinese Clinical Trial Registry ChiCTR2200062686; registered on August 15, 2022 (retrospectively registered).