Painless Gastroscopy Perioperative SedationPhase 4NCT07678411
ED90 of Tegileridine Combined With Propofol For Painless Gastroscopy
A Phase 4 study testing Tegileridine combined with Propofol for gastroscopy in people with Painless Gastroscopy Perioperative Sedation and Upper Gastrointestinal Tract Lesions, run by Shiyou Wei at 1 site in China.
Trial summary
This single-group, open-label, biased-coin up-and-down sequential dose-finding trial aims to determine the 90% effective dose (ED90) of intravenous tegileridine combined with fixed-dose propofol to eliminate body movement, cough and excessive hemodynamic fluctuations during gastroscopy insertion in adult patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Painless Gastroscopy Perioperative Sedation, Upper Gastrointestinal Tract Lesions
- What is being tested?
- Tegileridine combined with Propofol for gastroscopy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to 24 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
- Outpatients scheduled for elective painless gastroscopy
- Age ≥ 18 years old
- American Society of Anesthesiologists (ASA) physical status I-III
- Body mass index (BMI) between 18.5 and 29.9 kg/m²
Who cannot join
- Resting SBP ≥ 160 mmHg, DBP ≥ 110 mmHg, or heart rate ≥ 110 beats/min on admission to endoscopy 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 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: Determination of The 90% Effective Dose of Tegileridine Combined With Propofol for Gastroscopy in Patients of Different Ages: A Biased-Coin Up-and-down Design Study
This single-group, open-label, biased-coin up-and-down sequential dose-finding trial aims to determine the 90% effective dose (ED90) of intravenous tegileridine combined with fixed-dose propofol to eliminate body movement, cough and excessive hemodynamic fluctuations during gastroscopy insertion in adult patients stratified into young (18-64 years) and elderly (≥65 years) subgroups. All subjects receive intravenous tegileridine followed by 1-2 mg/kg propofol for sedation induction. The initial tegileridine dose is 5 μg/kg with a 1 μg/kg dose step. Dose adjustment follows biased-coin algorithm: dose increases by 1 μg/kg if positive response occurs; if negative response, there is an 11% probability to decrease dose by 1 μg/kg. The trial will be terminated when 45 successful cases are accrued in each age subgroup. Primary outcome is ED90 of tegileridine calculated via centered isotonic regression. Secondary outcomes include total propofol consumption, MOAA/S sedation score, blood pressure and heart rate changes, and incidence of perioperative adverse events within 24 hours post-procedure.
- Being tested
- Tegileridine combined with Propofol for gastroscopy
- Keywords
- Tegileridine, µ-opioid receptor G-protein-biased agonist, Biased-coin sequential allocation, gastroscopy, 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 gastroscopyDrug
All participants receive intravenous tegileridine with dose adjusted by biased-coin up-and-down sequential design, combined with fixed-dose propofol 1-2 mg/kg for anesthesia induction before painless gastroscopy. The initial dose of tegileridine is 5 μg/kg, with a 1 μg/kg step for dose increment or decrement according to gastroscopy insertion response. Subjects are stratified into young (18-64 years) and elderly (≥65 years) subgroups for separate ED90 calculation.
| Study group | Role | What they receive |
|---|---|---|
| Single Group (All Adult Patients Aged ≥18 Years) | Experimental | All enrolled adult patients receive variable-dose intravenous tegileridine adjusted by biased-coin up-and-down sequential design plus fixed-dose propofol 1-2 mg/kg for sedation during painless gastroscopy. Patients are stratified into young (18-64 years) and elderly (≥65 years) subgroups for separate ED90 analysis. Receives: Drug: Tegileridine combined with Propofol for gastroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
90% Effective Dose (ED90) of Tegileridine combined with propofol for gastroscopy
The 90% effective dose (ED90) of intravenous tegileridine combined with fixed-dose propofol 1-2 mg/kg to fully suppress positive responses during gastroscopy insertion, calculated via centered isotonic regression with 95% confidence interval. Positive response is defined as body movement, cough, or blood pressure/heart rate elevation exceeding 20% compared with baseline within 3 minutes after gastroscopy placement. Subjects are divided into young (18-64 years) and elderly (≥65 years) subgroups for separate ED90 estimation.
Measured: Within 3 minutes after gastroscopy insertion
Secondary outcomes (2)
Changes in blood pressure at predefined time points
Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) are recorded at: Baseline (prior to tegileridine administration) ,2 minutes after tegileridine bolus, Immediately before gastroscopy insertion, The highest values within 3 minutes following insertion
Measured: From baseline through 3 minutes after gastroscopy insertion.
Heart rate at predefined time points
Heart rate (HR) are recorded at: Baseline (before tegileridine injection), 2 minutes after tegileridine bolus, immediately before gastroscopy insertion, and the peak value within 3 minutes after insertion.
Measured: From baseline through 3 minutes after gastroscopy insertion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start1 Jul 2026
- Primary completion23 Jul 2026
- Study completion24 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Painless Gastroscopy Perioperative SedationStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 107 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
- NCT07678411
- Sponsor's protocol ID
- 20260254
- Status last verified
- Aug 2026
- First submitted
- 25 Jun 2026
- Last updated
- 4 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 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of The 90% Effective Dose of Tegileridine Combined With Propofol for Gastroscopy in Patients of Different Ages: A Biased-Coin Up-and-down Design Study
- ClinicalTrials.gov ID
- NCT07678411
- Acronym / sponsor ID
- 20260254
- Keywords
- Tegileridine, µ-opioid receptor G-protein-biased agonist, Biased-coin sequential allocation, gastroscopy, ED90
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Shiyou WeiUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 23 Jul 2026 (actual)
- Study completion
- 24 Jul 2026 (actual)
- First posted
- 1 Jul 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 single-group, open-label, biased-coin up-and-down sequential dose-finding trial aims to determine the 90% effective dose (ED90) of intravenous tegileridine combined with fixed-dose propofol to eliminate body movement, cough and excessive hemodynamic fluctuations during gastroscopy insertion in adult patients stratified into young (18-64 years) and elderly (≥65 years) subgroups. All subjects receive intravenous tegileridine followed by 1-2 mg/kg propofol for sedation induction. The initial tegileridine dose is 5 μg/kg with a 1 μg/kg dose step. Dose adjustment follows biased-coin algorithm: dose increases by 1 μg/kg if positive response occurs; if negative response, there is an 11% probability to decrease dose by 1 μg/kg. The trial will be terminated when 45 successful cases are accrued in each age subgroup. Primary outcome is ED90 of tegileridine calculated via centered isotonic regression. Secondary outcomes include total propofol consumption, MOAA/S sedation score, blood pressure and heart rate changes, and incidence of perioperative adverse events within 24 hours post-procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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 gastroscopyAll enrolled adult patients receive variable-dose intravenous tegileridine adjusted by biased-coin up-and-down sequential design plus fixed-dose propofol 1-2 mg/kg for sedation during painless gastroscopy. Patients are stratified into young (18-64 years) and elderly (≥65 years) subgroups for separate ED90 analysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Outpatients scheduled for elective painless gastroscopy
- Age ≥ 18 years old
- American Society of Anesthesiologists (ASA) physical status I-III
- Body mass index (BMI) between 18.5 and 29.9 kg/m²
Key exclusion criteria (4 listed)
- Resting SBP ≥ 160 mmHg, DBP ≥ 110 mmHg, or heart rate ≥ 110 beats/min on admission to endoscopy 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
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 gastroscopyAll participants receive intravenous tegileridine with dose adjusted by biased-coin up-and-down sequential design, combined with fixed-dose propofol 1-2 mg/kg for anesthesia induction before painless gastroscopy. The initial dose of tegileridine is 5 μg/kg, with a 1 μg/kg step for dose increment or decrement according to gastroscopy insertion response. Subjects are stratified into young (18-64 years) and elderly (≥65 years) subgroups for separate ED90 calculation. | Drug | Single Group (All Adult Patients Aged ≥18 Years) |
Primary outcome
90% Effective Dose (ED90) of Tegileridine combined with propofol for gastroscopy
Time frame: Within 3 minutes after gastroscopy insertion
The 90% effective dose (ED90) of intravenous tegileridine combined with fixed-dose propofol 1-2 mg/kg to fully suppress positive responses during gastroscopy insertion, calculated via centered isotonic regression with 95% confidence interval. Positive response is defined as body movement, cough, or blood pressure/heart rate elevation exceeding 20% compared with baseline within 3 minutes after gastroscopy placement. Subjects are divided into young (18-64 years) and elderly (≥65 years) subgroups for separate ED90 estimation.
2 secondary outcomes
Changes in blood pressure at predefined time points
Time frame: From baseline through 3 minutes after gastroscopy insertion.
Heart rate at predefined time points
Time frame: From baseline through 3 minutes after gastroscopy 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 4 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 gastroscopy in people with Painless Gastroscopy Perioperative Sedation and Upper Gastrointestinal Tract Lesions, 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 4 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 4 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 combined with propofol for gastroscopy (time frame: Within 3 minutes after gastroscopy 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 4 Aug 2026.