Tracheal IntubationNCT07749131
ED90 of Tegileridine for Suppressing Hemodynamic Response to Tracheal Intubation: A Biased Coin Up-and-Down Trial
A study testing Tegileridine in people with Tracheal Intubation and Anesthesia, General, run by Shiyou Wei at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Tracheal Intubation, Anesthesia, General, Hemodynamics
- What is being tested?
- Tegileridine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 5 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status I-III
- Aged ≥18 ears old
- Scheduled for elective surgery requiring general anesthesia with tracheal intubation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shaoyang University Affiliated First Hospital
Shaoyang, Hunan, 422000
Yadan Liu, Doc, 18229421255, lyd26897@163.com
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Tracheal Intubation, Anesthesia, General, Hemodynamics
- Being tested
- Tegileridine
- Keywords
- Tegileridine, Hemodynamic Stress Response, ED90
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TegileridineDrug
Also called SHR8554
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Tegileridine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 3 minutes after tracheal intubation
Secondary 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).
Measured: From the start of tegileridine injection until 2 minutes after completion of injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion5 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tracheal IntubationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shiyou Wei
- Sponsor type
- University, hospital or other
- Collaborators
- Shaoyang University Affiliated First Hospital, Shaoyang, Hunan Province, China
- Responsible party
- Sponsor-investigator, Shiyou Wei, Shanghai Pulmonary Hospital, Shanghai, China
- Investigators
- Xin Lv, PhD, Principal investigator, Shanghai Pulmonary Hospital, School of Medicine, Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07749131
- Sponsor's protocol ID
- shaoyang-001
- Status last verified
- Aug 2026
- First submitted
- 1 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07749131
- Acronym / sponsor ID
- shaoyang-001
- Conditions
- Tracheal Intubation, Anesthesia, General, Hemodynamics
- Keywords
- Tegileridine, Hemodynamic Stress Response, ED90
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Shiyou WeiUniversity, hospital or other
- Collaborators
- Shaoyang University Affiliated First Hospital, Shaoyang, Hunan Province, China
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 5 Oct 2026 (estimated)
- First posted
- 6 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Drug: TegileridineAll 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) physical status I-III
- Aged ≥18 ears old
- Scheduled for elective surgery requiring general anesthesia with tracheal intubation
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TegileridineAlso: SHR8554Intravenous 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. | Drug | Intervention Arm |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xin Lv, PhD principal investigator
Shanghai Pulmonary Hospital, School of Medicine, Tongji University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tegileridine in people with Tracheal Intubation and Anesthesia, General, run by Shiyou Wei at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shiyou Wei, Doc (15601680288, lovewishyou@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ED90 to suppress hemodynamic response of tracheal intubation (time frame: Within 3 minutes after tracheal intubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.