Clinical Trial

ED90 of Tegileridine for Suppressing Hemodynamic Response to Tracheal Intubation: A Biased Coin Up-and-Down Trial

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Summary
General anesthesia tracheal intubation causes sympathetic activation and hemodynamic stress response, which increases perioperative cardiovascular risk, especially in elderly subjects. Tegileridine fumarate is a novel μ-opioid receptor G protein-biased agonist. However, the optimal dose of tegileridine to suppress intubation-induced hemodynamic fluctuations during anesthesia induction remains unclear. This is an open-label, single-center, age-stratified biased coin up-and-down sequential trial. Subjects undergoing elective surgery requiring tracheal intubation will be divided into young adult group (18-64 years) and elderly group (≥65 years). The primary objective is to determine the ED90 of intravenous tegileridine for inhibiting hemodynamic response to tracheal intubation using centered isotonic regression. Secondary outcomes include induction-related adverse events, serial hemodynamic parameters and sedation scale. This study will provide evidence for rational dosing of tegileridine in clinical anesthesia induction.
Trial Details
NCT Number NCT07749131
Lead Sponsor Shiyou Wei
Collaborators: Shaoyang University Affiliated First Hospital, Shaoyang, Hunan Province, China
Conditions Tracheal Intubation, Anesthesia, General, Hemodynamics
Enrollment 108 participants
Start Date 2026-09-01
Primary Completion 2026-09-30 (estimated)
Study Completion 2026-10-05 (estimated)
Updated on ClinicalTrials.gov 2026-08-06