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

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 investigational-drug adverse events, serial hemodynamic parameters. This study will provide evidence for rational dosing of tegileridine in clinical anesthesia induction.

Inclusion Criteria: * American Society of Anesthesiologists (ASA) physical status I-III * Aged ≥18 ears old * Scheduled for elective surgery requiring general anesthesia with tracheal intubation Exclusion Criteria: * Resting Systolic Blood Pressure ≥ 160 mmHg, Diastolic Blood Pressure ≥ 110 mmHg, or heart rate ≥ 110 beats/min on admission to operation room * Continuous opioid medication use for more than 2 weeks within 6 months before the procedure * Known hypersensitivity or allergic reaction to tegileridine, propofol or any excipients of the two drugs * Diagnosed psychiatric disorders or inability to communicate and cooperate with study assessment * Anticipated difficult airway