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NCT Number: NCT07749131

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.

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Key information

Conditions

Tracheal Intubation Anesthesia, General Hemodynamics

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shaoyang University Affiliated First Hospital

Shaoyang, Hunan, 422000, China

Location contact

Yadan Liu, Doc

CONTACT

[email protected]

18229421255

About this study

Tracheal intubation under general anesthesia stimulates the airway and triggers transient hypertension and tachycardia due to sympathetic excitation. Excessive hemodynamic fluctuations may trigger myocardial ischemia, arrhythmia and other adverse cardiovascular events. Traditional opioids simultaneously activate G-protein and β-arrestin pathways, often accompanied by obvious respiratory depression. As a newly marketed biased μ-opioid agonist, tegileridine exerts analgesic effects with reduced β-arrestin related side effects. Up to now, few studies have explored the effective dose of tegileridine for blunting intubation stress.

We conduct a single-center, open-label sequential dose-finding trial stratified by age. Eligible subjects are ASA I-III patients scheduled for elective surgery with tracheal intubation. Subjects receive intravenous tegileridine before anesthetic induction. The dose is adjusted according to biased coin up-and-down rule based on whether a positive cardiovascular response occurs after intubation. We adopt centered isotonic regression to calculate the 90% effective dose (ED90). Blood pressure, heart rate, investigational-drug adverse reactions will be recorded.The findings of this trial will establish a dosing reference of tegileridine for anesthesia induction and facilitate safer perioperative management.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: SHR8554

Primary outcomes

  1. ED90 to suppress hemodynamic response of tracheal intubation

    Time frame: Within 3 minutes after tracheal intubation

    Successful suppression of hemodynamic response is defined as a maximum increase in hemodynamic variables ≤20% from baseline within 3 minutes after tracheal intubation. Centered isotonic regression will be used to calculate the ED₉₀ of tegileridine.

Secondary outcomes

  1. Number of subjects with cough during the study drug (tegileridine) administration and observation period.

    Time frame: From the start of tegileridine injection until 2 minutes after completion of injection.

    Number of subjects with cough during the study drug (tegileridine) administration and observation period, with severity graded as: Mild (1-2 episodes), Moderate (3-5 episodes), Severe (>5 episodes).

Other outcomes

  1. Hypotension

    Time frame: From the start of tegileridine injection until 2 minutes after completion of injection.

    Hypotension is defined as systolic blood pressure < 90 mmHg or mean arterial pressure (MAP) < 60 mmHg.

  2. Bradycardia

    Time frame: From the start of tegileridine injection until 2 minutes after completion of injection.

    Bradycardia is defined as heart rate < 50 beats per minute.

  3. Injection pain

    Time frame: From the start of tegileridine injection until 2 minutes after completion of injection.

    Pain induced by drug injection, assessed immediately after intravenous drug administration.

  4. Chest wall rigidity

    Time frame: From the start of tegileridine injection until 2 minutes after completion of injection.

    Chest wall rigidity is defined as opioid-induced increased tone of thoracic and abdominal muscles leading to reduced chest-wall compliance and difficulty with manual or mechanical ventilation.

  5. Respiratory depression

    Time frame: From the start of tegileridine injection until 2 minutes after completion of injection.

    Respiratory depression is defined as the presence of at least one of the following: respiratory rate (RR) < 8 breaths per minute in adults; arterial oxygen saturation (SpO₂) < 90 mmHg despite oxygen supplementation; shallow, slow and ineffective ventilation accompanied by somnolence or reduced level of consciousness (excessive sedation); arterial blood gas showing PaCO₂ >50 mmHg together with pH <7.30.

  6. Allergic reaction

    Time frame: From the start of tegileridine injection until 2 minutes after completion of injection.

    Allergic reaction is defined as drug-mediated hypersensitivity manifestations occurring after intravenous injection, including skin rash, urticaria, flushing, bronchospasm, hypotension or other immune-mediated adverse events.

  7. Dizziness

    Time frame: From the start of tegileridine injection until 2 minutes after completion of injection.

    Dizziness is defined as a subjective sensation of light-headedness or unsteadiness reported by the subject following study drug administration.

  8. Palpitation

    Time frame: From the start of tegileridine injection until 2 minutes after completion of injection.

    Palpitation is defined as the subject-reported unpleasant awareness of abnormal or forceful heartbeats after study drug injection.

  9. Hypoxemia

    Time frame: From the start of tegileridine injection until 2 minutes after completion of injection.

    Peripheral oxygen saturation SpO₂ <92% on pulse oximetry.

  10. Pruritus

    Time frame: From the start of tegileridine injection until 2 minutes after completion of injection.

    Subject reports generalized or local pruritus after sufentanil administration.

Study contacts

Contact information is provided by the study sponsor or research team.

Shiyou Wei, Doc

CONTACT

[email protected]

15601680288

Sponsors and collaborators

Lead sponsor

Shiyou Wei

Other

Collaborators

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

Registry information

Official study title

Determination of the 90% Effective Dose (ED90) of Tegileridine Fumarate for Inhibiting Hemodynamic Stress Response Induced by Tracheal Intubation During General Anesthesia: A Biased Coin Up-and-Down Sequential Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 6, 2026
Registry last updated
Aug 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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