Clinical Research Directory

90% Effective Infusion Time of Sufentanil to Prevent Induction Cough: A Biased Coin Sequential Study

Sponsor: Shiyou Wei

Summary

This single-center, prospective biased coin up-and-down sequential study aims to determine the 90% effective infusion time (ET90) of sufentanil to prevent sufentanil-induced cough (SIC) during the induction phase of general anesthesia in adults undergoing endotracheal intubation. Two age cohorts are studied separately: younger adults (\<65 years) and older adults (≥65 years). The trial does not test superiority or between-group differences as the primary objective. All participants receive sufentanil via a peripheral intravenous pump. The total sufentanil dose is fixed within each age cohort (young: 0.40 μg/kg; elderly: 0.30 μg/kg), while the pump injection time is adjusted using the biased coin up-and-down allocation method. SIC success is defined as no audible cough within a prespecified observation window from the start of the infusion until 2 minutes after infusion ends. The primary outcome is the ET90 of sufentanil and its 95% confidence interval for each age cohort, estimated using centered isotonic regression with bootstrap confidence intervals. Approximately 120 patients will be screened to obtain at least 54 evaluable participants per cohort.

Official title: Determination of the 90% Effective Infusion Time of Sufentanil to Prevent Sufentanil-Induced Cough During General Anesthesia Induction in Young and Elderly Patients: A Biased Coin Design Up-and-Down Sequential Study

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