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

NCT07749131 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2026-08-06

No results posted yet for this study

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

Interventions

DRUG

Tegileridine

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.

Sponsors & Collaborators

  • Shaoyang University Affiliated First Hospital, Shaoyang, Hunan Province, China

    collaborator UNKNOWN

  • Shiyou Wei

    lead OTHER

Principal Investigators

  • Xin Lv, PhD · Shanghai Pulmonary Hospital, School of Medicine, Tongji University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2026-09-30
Completion
2026-10-05

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07749131 on ClinicalTrials.gov