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ED90 of Tegileridine Combined With Propofol for LMA Insertion
Sponsor: Shiyou Wei
Summary
This is a prospective two-group dose-finding trial using biased-coin sequential up-and-down design. We plan to enroll 108 patients who need general anesthesia with laryngeal mask airway placement, divided into young group (18-65 years old) and elderly group (65 years old and older). All patients will receive tegileridine combined with fixed-dose propofol for anesthesia induction. The main goal is to find the 90% effective dose (ED90) of tegileridine that can fully block body movement, cough, tearing and unstable blood pressure/heart rate during laryngeal mask insertion. We will also record cough rate, hemodynamic changes, sedation depth and all perioperative adverse reactions to provide safe dosing reference for different age patients in clinical anesthesia.
Official title: 90% Effective Dose of Tegileridine Combined With Propofol for Inhibiting Laryngeal Mask Airway Insertion Responses in Patients of Different Ages: A Biased-Coin Sequential Allocation Dose-Finding Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
108
Start Date
2026-07-10
Completion Date
2026-08-10
Last Updated
2026-06-24
Healthy Volunteers
No
Interventions
Tegileridine combined with Propofol for anesthesia induction
Intravenous tegileridine with variable dose adjusted by biased-coin sequential design, combined with fixed-dose propofol 2 mg/kg for general anesthesia induction before laryngeal mask airway placement.
Locations (1)
Tianmen First People's Hospital, Affiliated Hospital of Wuhan University of Science and Technology
Tianmen, Hubei, China