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NOT YET RECRUITING
NCT07665151
PHASE4

ED90 of Tegileridine Combined With Propofol for LMA Insertion

Sponsor: Shiyou Wei

View on ClinicalTrials.gov

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

DRUG

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