ED90 of Tegileridine for Suppressing Hemodynamic Response to Tracheal Intubation: A Biased Coin Up-and-Down Trial
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorShiyou Wei
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
American Society of Anesthesiologists (ASA) physical status I-III
Aged ≥18 ears old
Scheduled for elective surgery requiring general anesthesia with tracheal intubation
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Tegileridine
DrugIntravenous 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.
Treatment groups
108 Participants
are divided into 1 treatment groupGroup A: Intervention ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
ED90 to suppress hemodynamic response of 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.
Time frame
Within 3 minutes after tracheal intubationSecondary outcomes
1
Number of subjects with cough during the study drug (tegileridine) administration and observation period.
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).
Time frame
From the start of tegileridine injection until 2 minutes after completion of injection.Other outcomes
1
Hypotension
Hypotension is defined as systolic blood pressure \< 90 mmHg or mean arterial pressure (MAP) \< 60 mmHg.
Time frame
From the start of tegileridine injection until 2 minutes after completion of injection.2
Bradycardia
Bradycardia is defined as heart rate \< 50 beats per minute.
Time frame
From the start of tegileridine injection until 2 minutes after completion of injection.3
Injection pain
Pain induced by drug injection, assessed immediately after intravenous drug administration.
Time frame
From the start of tegileridine injection until 2 minutes after completion of injection.4
Chest wall rigidity
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.
Time frame
From the start of tegileridine injection until 2 minutes after completion of injection.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Shiyou Wei
Lead sponsor
Shanghai Pulmonary Hospital, Shanghai, China
Sponsor institution
Shaoyang University Affiliated First Hospital, Shaoyang, Hunan Province, China
Collaborator
Source ClinicalTrials.gov
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