Fospropofol Disodium Combined With Sufentanil Impact on the Endotracheal Intubation--Induced Cardiovascular Response: A Dose-Finding Study.

Purpose: The objective of this study is to ascertain the 95% effective dose (ED95) of fospropofol disodium for injection (fospropofol) combined with sufentanil for the attenuation of cardiovascular reactions to endotracheal intubation, to determine the optimal dosage of fospropofol disodium for clinical safe medication use in different populations.

Design: This study employed a biased coin design (BCD)-based up-and-down sequential allocation trial method.

Methods: Eighty surgical patients who received fospropofol disodium combined with sufentanil for general anesthesia induction at the First Affiliated Hospital of Nanchang University between March and September 2023 were enrolled. Participants were stratified into two cohorts: middle-aged group (18 to 59 years, n=40, Group A) and elderly group (60 to 89 years, n=40, Group O). The fospropofol disodium dosage was titrated according to the preceding patient's cardiovascular response, with dose increments set at 0.5 mg/kg. Positive cardiovascular response was defined as heart rate or blood pressure fluctuations exceeding 20% from baseline. Furthermore, isotonic regression analysis was implemented to calculate the 95% effective dose (ED95).

Findings: The ED95 of fospropofol combined with 0.4 mcg/kg sufentanil for anesthesia induction to mitigate cardiovascular responses was determined to be 13.8 mg/kg (95% CI: 13.57 to 14.1 mg/kg) for Group A and 9.89 mg/kg (95% CI: 9.84 to 9.90 mg/kg) for Group O, with no overlap in confidence intervals between the two groups, indicating a significant difference (p<0.01).

Conclusions: The ED95 differed between patients aged 18 to 59 years and those aged 60 to 89 years, yielding values of 13.8 mg/kg and 9.89 mg/kg, respectively, with the older group demonstrating heightened sensitivity to fospropofol. Pruritus and paresthesia were the primary adverse reactions observed in the study.