Effective dose of remimazolam co-administered with remifentanil to facilitate I-gel insertion without neuromuscular blocking agents: an up-and-down sequential allocation trial

BACKGROUND: Remimazolam is a new anesthetic drug developed and is an ultra-short-acting agent with rapid onset and offset. The pharmacology of this drug seems to be ideal for short surgeries eligible for I-gel insertion. Therefore, this study aimed to determine the optimal bolus dose of remimazolam for I-gel insertion when co-administered with remifentanil without neuromuscular blocking agents (NMBAs). METHODS: Patients aged 19–65 years with American Society of Anesthesiologists physical status I or II scheduled for general anesthesia were enrolled. The first dose of remimazolam was 0.15 mg/kg and remifentanil was co-administered at an effect-site concentration (Ce) of 3.0 ng/mL. The dose of remimazolam for the following patient was decreased or increased by 0.05 mg/kg depending on the success or failure of I-gel insertion in the previous patient. RESULTS: The remimazolam bolus dose required for successful I-gel insertion in 50% of adult patients using modified Dixon’s up-and-down method with remifentanil Ce 3.0 ng/mL and no NMBAs was 0.280 ± 0.048 mg/kg. Isotonic regression analysis showed that the 50% and 95% effective doses were 0.244 (83% confidence interval [CI] 0.213–0.313) mg/kg and 0.444 (95% CI 0.436–0.448) mg/kg, respectively. The mean time to loss of consciousness (Modified Observer’s Assessment of Alertness/Sedation score < 2) was 52.2 s. Three patients (12.0%) showed a reduction in systolic blood pressure of more than 30% from baseline. CONCLUSIONS: Selecting the appropriate dose of remimazolam/remifentanil without NMBAs makes it feasible to insert the I-gel. TRIAL REGISTRATION: This study protocol was registered at http://cris.nih.go.kr (KCT0007801, 12th, October, 2022).