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

NCT07749131 | Not Yet Recruiting

• 1 other identifier: shaoyang-001
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tracheal Intubation; Anesthesia, General; Hemodynamics

Keywords

Tegileridine; Hemodynamic Stress Response; ED90

Outcome Measures

Primary Outcomes (1)

• ED90 to suppress hemodynamic response of tracheal intubation

  Successful suppression of hemodynamic response is defined as maximum increase of mean arterial pressure or heart rate ≤20% compared with baseline within 3 minutes after tracheal intubation. Centered isotonic regression will be used to calculate the ED90 of tegileridine.

  Within 3 minutes after tracheal intubation

Study Arms (1)

Intervention Arm

EXPERIMENTAL

All enrolled subjects receive intravenous tegileridine before anesthesia induction. The dose of tegileridine is adjusted sequentially for each subsequent subject following the biased coin up-and-down rule. General anesthesia and tracheal intubation are performed according to standardized protocol.

Drug: Tegileridine

Interventions

Tegileridine DRUG

Intravenous tegileridine administered prior to anesthesia induction. The initial dose and dose adjustment steps are predefined; individual dose will be modified by biased coin up-and-down sequential method to explore ED90 for inhibiting hemodynamic response to tracheal intubation.

Also known as: SHR8554

Intervention Arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status I-III
• Aged 18-90 years old
• Scheduled for elective surgery requiring general anesthesia with tracheal intubation
• No predicted difficult airway

You may not qualify if:

• Resting Systolic Blood Pressure ≥ 160 mmHg, Diastolic Blood Pressure ≥ 110 mmHg, or heart rate ≥ 110 beats/min on admission to endoscopy 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

Sponsors & Collaborators

• Shiyou Wei: lead
• Shaoyang University Affiliated First Hospital, Shaoyang, Hunan Province, China: collaborator

Study Sites (1)

Shaoyang University Affiliated First Hospital

Shaoyang, Hunan, 422000, China

Location

Study Officials

• Xin Lv, PhD

  Shanghai Pulmonary Hospital, School of Medicine, Tongji University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shiyou Wei, Doc

CONTACT

15601680288; lovewishyou@tongji.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending Physician, Department of Anesthesiology

Model Details: Single-group open-label biased coin up-and-down sequential dose-finding trial stratified by age. The dose of tegileridine is dynamically adjusted for each subsequent subject according to the cardiovascular response after tracheal intubation.

Study Record Dates

• First Submitted: August 1, 2026
• First Posted: August 6, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 5, 2026
• Last Updated: August 6, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)