Clinical Trial

ED90 of Tegileridine Combined With Propofol for LMA Insertion

Completed Phase 4
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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 (18-64 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.
Protocol Amendment History 1 change
critical Completed without a posted recruiting period 2026-08-12
Trial Details
NCT Number NCT07665151
Lead Sponsor Shiyou Wei
Conditions Elective Surgery Requiring Laryngeal Mask Airway General Anesthesia
Enrollment 109 participants
Start Date 2026-06-25
Primary Completion 2026-07-20 (estimated)
Study Completion 2026-07-21 (estimated)
Updated on ClinicalTrials.gov 2026-08-11