ED90 of Tegileridine Combined With Propofol for LMA Insertion

Shiyou Wei

Status and phase: Completed; Phase 4

Conditions: Elective Surgery Requiring Laryngeal Mask Airway General Anesthesia

Treatments: Drug: Tegileridine combined with Propofol for anesthesia induction

Study type: Interventional

Funder types: Other

Identifiers

NCT07665151

tianmen20260016

Details and patient eligibility

About

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.

Enrollment: 109 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Elective surgery requiring general anesthesia with laryngeal mask airway insertion
• Age ≥ 18 years
• American Society of Anesthesiologists (ASA) physical status I-III

Exclusion criteria

• At rest in the operating room, systolic blood pressure ≥ 160 mmHg or - diastolic blood pressure ≥ 110 mmHg or heart rate ≥ 110 bpm
• Continuous opioid medication for more than 2 weeks within half a year before surgery
• Known allergy or hypersensitivity to tegileridine or any study medication components
• History of psychiatric illness or inability to communicate effectively

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

---

109 participants in 1 patient group

Single Group (All Adult Patients Aged ≥18 Years)

Experimental group

Description:

All enrolled adult patients aged ≥18 years receive intravenous tegileridine followed by fixed-dose propofol 2 mg/kg for anesthesia induction. This single-group biased-coin sequential up-and-down design starts with an initial tegileridine dose of 10 μg/kg, with 1 μg/kg dose step for increment or decrement based on laryngeal mask airway insertion response. Patients are stratified into young subgroup (18-64 years) and elderly subgroup (≥65 years) for separate ED90 calculation. Intraoperative anesthesia maintenance and perioperative supportive treatments are consistent for all subjects.

Treatment:

Drug: Tegileridine combined with Propofol for anesthesia induction