Elective Surgery Requiring Laryngeal Mask Airway General AnesthesiaPhase 4NCT07665151
ED90 of Tegileridine Combined With Propofol for LMA Insertion
A Phase 4 study testing Tegileridine combined with Propofol for anesthesia induction in people with Elective Surgery Requiring Laryngeal Mask Airway General Anesthesia, run by Shiyou Wei at 1 site in China.
Trial summary
This is a prospective two-group dose-finding trial using biased-coin sequential up-and-down design. We plan to enroll 108 patients who need general anesthesia with laryngeal mask airway placement, divided into young group (18-64 years old) and elderly group (65 years old and older). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elective Surgery Requiring Laryngeal Mask Airway General Anesthesia
- What is being tested?
- Tegileridine combined with Propofol for anesthesia induction
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteChina
- Study dates
- 25 Jun 2026to 21 Jul 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective surgery requiring general anesthesia with laryngeal mask airway insertion
- Age ≥ 18 years
- American Society of Anesthesiologists (ASA) physical status I-III
Who cannot join
- At rest in the operating room, systolic blood pressure ≥ 160 mmHg or - diastolic blood pressure ≥ 110 mmHg or heart rate ≥ 110 bpm
- Continuous opioid medication for more than 2 weeks within half a year before surgery
- Known allergy or hypersensitivity to tegileridine or any study medication components
- History of psychiatric illness or inability to communicate effectively
Trial locations and contacts
1 site in 1 country.
China1 site
Tianmen First People's Hospital, Affiliated Hospital of Wuhan University of Science and Technology
Tianmen, Hubei, 431700
About this study
Official title: 90% Effective Dose of Tegileridine Combined With Propofol for Inhibiting Laryngeal Mask Airway Insertion Responses in Patients of Different Ages: A Biased-Coin Sequential Allocation Dose-Finding Study
This is a prospective two-group dose-finding trial using biased-coin sequential up-and-down design. We plan to enroll 108 patients who need general anesthesia with laryngeal mask airway placement, divided into young group (18-64 years old) and elderly group (65 years old and older). All patients will receive tegileridine combined with fixed-dose propofol for anesthesia induction. The main goal is to find the 90% effective dose (ED90) of tegileridine that can fully block body movement, cough, tearing and unstable blood pressure/heart rate during laryngeal mask insertion. We will also record cough rate, hemodynamic changes, sedation depth and all perioperative adverse reactions to provide safe dosing reference for different age patients in clinical anesthesia.
- Being tested
- Tegileridine combined with Propofol for anesthesia induction
- Keywords
- Tegileridine, µ-opioid receptor G-protein-biased agonist, laryngeal mask airway, Biased-coin sequential allocation, ED90
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tegileridine combined with Propofol for anesthesia inductionDrug
Intravenous tegileridine with variable dose adjusted by biased-coin sequential design, combined with fixed-dose propofol 2 mg/kg for general anesthesia induction before laryngeal mask airway placement.
| Study group | Role | What they receive |
|---|---|---|
| Single Group (All Adult Patients Aged ≥18 Years) | Experimental | All enrolled adult patients aged ≥18 years receive intravenous tegileridine followed by fixed-dose propofol 2 mg/kg for anesthesia induction. This single-group biased-coin sequential up-and-down design starts with an initial tegileridine dose of 10 μg/kg, with 1 μg/kg dose step for increment or decrement based on laryngeal mask airway insertion response. Patients are stratified into young subgroup (18-64 years) and elderly subgroup (≥65 years) for separate ED90 calculation. Intraoperative anesthesia maintenance and perioperative supportive treatments are consistent for all subjects. Receives: Drug: Tegileridine combined with Propofol for anesthesia induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
90% Effective Dose (ED90) of Tegileridine for Suppressing Laryngeal Mask Airway Insertion Response
The 90% effective dose of intravenous tegileridine combined with fixed-dose propofol to completely inhibit positive responses during laryngeal mask airway insertion, calculated via central ordinal regression with 95% confidence interval. Positive response is defined as any body movement, frowning, tearing, cough, or blood pressure/heart rate increase over 20% compared with baseline within 3 minutes after LMA placement.
Measured: Within 3 minutes after laryngeal mask airway insertion
Secondary outcomes (2)
Incidence of cough during laryngeal mask airway insertion
During anesthesia induction, intravenous injection of opioids may cause coughing.
Measured: From the start of anesthesia induction to the end of anesthesia induction .
Success rate of sedation
The modified observer's assessment of alert/sedation scale (MOAA/S) is a commonly - used sedation evaluation tool in clinical practice. It classifies reactivity under different stimuli: Grade 5 means a sensitive response to calling the name in a normal tone of voice; Grade 4 indicates a sluggish response to calling the name in a normal tone of voice; Grade 3 requires a loud or repeated call of the name to elicit a response; Grade 2 shows a response to slight pushing and vibration; Grade 1 has a response to a painful stimulus (by squeezing the trapezius muscle area); Grade 0 means no response to a painful stimulus. Moreover, MOAA/S ≤ 2 indicates loss of consciousness, which can assist medical staff in judging the sedation level and consciousness state of patients.
Measured: From the start of intubation to 3 minutes after the end of laryngeal mask airway insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start25 Jun 2026
- Primary completion20 Jul 2026
- Study completion21 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elective Surgery Requiring Laryngeal Mask Airway General AnesthesiaStudies 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 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiyou Wei
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shiyou Wei, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07665151
- Sponsor's protocol ID
- tianmen20260016
- Status last verified
- Aug 2026
- First submitted
- 18 Jun 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 90% Effective Dose of Tegileridine Combined With Propofol for Inhibiting Laryngeal Mask Airway Insertion Responses in Patients of Different Ages: A Biased-Coin Sequential Allocation Dose-Finding Study
- ClinicalTrials.gov ID
- NCT07665151
- Acronym / sponsor ID
- tianmen20260016
- Keywords
- Tegileridine, µ-opioid receptor G-protein-biased agonist, laryngeal mask airway, Biased-coin sequential allocation, ED90
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Shiyou WeiUniversity, hospital or other
- Study start
- 25 Jun 2026 (actual)
- Primary completion
- 20 Jul 2026 (actual)
- Study completion
- 21 Jul 2026 (actual)
- First posted
- 24 Jun 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.
This is a prospective two-group dose-finding trial using biased-coin sequential up-and-down design. We plan to enroll 108 patients who need general anesthesia with laryngeal mask airway placement, divided into young group (18-64 years old) and elderly group (65 years old and older). All patients will receive tegileridine combined with fixed-dose propofol for anesthesia induction. The main goal is to find the 90% effective dose (ED90) of tegileridine that can fully block body movement, cough, tearing and unstable blood pressure/heart rate during laryngeal mask insertion. We will also record cough rate, hemodynamic changes, sedation depth and all perioperative adverse reactions to provide safe dosing reference for different age patients in clinical anesthesia.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group (All Adult Patients Aged ≥18 Years) | Experimental | Drug: Tegileridine combined with Propofol for anesthesia inductionAll enrolled adult patients aged ≥18 years receive intravenous tegileridine followed by fixed-dose propofol 2 mg/kg for anesthesia induction. This single-group biased-coin sequential up-and-down design starts with an initial tegileridine dose of 10 μg/kg, with 1 μg/kg dose step for increment or decrement based on laryngeal mask airway insertion response. Patients are stratified into young subgroup (18-64 years) and elderly subgroup (≥65 years) for separate ED90 calculation. Intraoperative anesthesia maintenance and perioperative supportive treatments are consistent for all subjects. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elective surgery requiring general anesthesia with laryngeal mask airway insertion
- Age ≥ 18 years
- American Society of Anesthesiologists (ASA) physical status I-III
Key exclusion criteria (4 listed)
- At rest in the operating room, systolic blood pressure ≥ 160 mmHg or - diastolic blood pressure ≥ 110 mmHg or heart rate ≥ 110 bpm
- Continuous opioid medication for more than 2 weeks within half a year before surgery
- Known allergy or hypersensitivity to tegileridine or any study medication components
- History of psychiatric illness or inability to communicate effectively
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 |
|---|---|---|
| Tegileridine combined with Propofol for anesthesia inductionIntravenous tegileridine with variable dose adjusted by biased-coin sequential design, combined with fixed-dose propofol 2 mg/kg for general anesthesia induction before laryngeal mask airway placement. | Drug | Single Group (All Adult Patients Aged ≥18 Years) |
Primary outcome
90% Effective Dose (ED90) of Tegileridine for Suppressing Laryngeal Mask Airway Insertion Response
Time frame: Within 3 minutes after laryngeal mask airway insertion
The 90% effective dose of intravenous tegileridine combined with fixed-dose propofol to completely inhibit positive responses during laryngeal mask airway insertion, calculated via central ordinal regression with 95% confidence interval. Positive response is defined as any body movement, frowning, tearing, cough, or blood pressure/heart rate increase over 20% compared with baseline within 3 minutes after LMA placement.
2 secondary outcomes
Incidence of cough during laryngeal mask airway insertion
Time frame: From the start of anesthesia induction to the end of anesthesia induction .
Success rate of sedation
Time frame: From the start of intubation to 3 minutes after the end of laryngeal mask airway insertion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tegileridine combined with Propofol for anesthesia induction in people with Elective Surgery Requiring Laryngeal Mask Airway General Anesthesia, 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 4 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: finished, as of the sponsor's last update on 11 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
90% Effective Dose (ED90) of Tegileridine for Suppressing Laryngeal Mask Airway Insertion Response (time frame: Within 3 minutes after laryngeal mask airway insertion). 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 11 Aug 2026.