SedationNCT07880899
The Impact of Long-term High-risk Drinking on the Effective Dose of Osselidin
A study testing long-term high-risk drinking and non-drinking in people with Sedation, run by Affiliated Hospital of Jiaxing University at 1 site in China.
Trial summary
this study aims to investigate the effect of chronic high-risk alcohol consumption on the effective dose of oliceridine combined with propofol for painless gastroscopy, so as to provide a reference for rational clinical medication. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Sedation
- What is being tested?
- long-term high-risk drinking and non-drinking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2026to 20 Dec 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- This study enrolled patients undergoing elective painless gastroscopy, aged 18-64 years, with American Society of Anesthesiologists (ASA) physical status classification I-II, and body mass index (BMI) of 18-27 kg/m².
Who cannot join
- Difficult airway (modified Mallampati grade IV); poorly controlled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg); hepatic or renal insufficiency, liver cirrhosis, significant organ dysfunction, severe cardiovascular disease, or arrhythmia; history of long-term use of sedatives, antipsychotics or analgesics; signs of alcohol withdrawal or alcohol addiction (e.g., inability to reduce alcohol intake despite obvious harmful effects, or morning tremors relieved by alcoholic beverages); mental disorders that impede proper self-expression; allergy to study-related medications or acute-phase asthma medications; known or suspected gastrointestinal obstruction; pregnancy or lactation, etc.
- Exclusion of cases: prolonged examination time due to difficult endoscopic manipulation; severe complications requiring emergency treatment such as hypoxemia and circulatory fluctuation, which violate the study protocol.
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
Affiliated Hospital of Jiaxing University
Jiaxing, Zhejiang
Yazhi Xi, 15536368031, xiyazhi1996@163.com
About this study
Official title: The Impact of Long-term High-risk Drinking on the 90% Effective Dose of Osselidin in Adult Males Undergoing Painless Gastroscopy
this study aims to investigate the effect of chronic high-risk alcohol consumption on the effective dose of oliceridine combined with propofol for painless gastroscopy, so as to provide a reference for rational clinical medication.
Read the detailed description
The primary objective of our study is to use a biased coin up-down alloocation methology to estimate the dose of oliceridine combined with propofol for sedation of painless gastroscopy. Thus, this study was designed to compare the effective doses of oliceridine for successful insertion of gastroscopy between long-term high-risk drinking and non-drinking patients.
- Conditions
- Sedation
- Being tested
- long-term high-risk drinking, non-drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
long-term high-risk drinkingOther
If a patient had failed gastroscope insertion, the next patient would receive a higher dose (an increasing of 1.5 μg/kg). However, if a patient had successful gastroscpe insertion, the next patient would receive a lower dose (a decreasing of 1.5 μg/kg) with a probability of approximately B ≈ 0.11 (i.e., 1/9), or the same dose with a probability of 1 - B = 0.89 (i.e., 8/9). The initial dosage of oliceridine was set at 13 μg/kg, with an up-down dose of 1.5 μg/kg, based on our hospital's experience and findings in the literature.
non-drinkingOther
If a patient had failed gastroscope insertion, the next patient would receive a higher dose (an increasing of 1.5 μg/kg). However, if a patient had successful gastroscpe insertion, the next patient would receive a lower dose (a decreasing of 1.5 μg/kg) with a probability of approximately B ≈ 0.11 (i.e., 1/9), or the same dose with a probability of 1 - B = 0.89 (i.e., 8/9). The initial dosage of oliceridine was set at 13 μg/kg, with an up-down dose of 1.5 μg/kg, based on our hospital's experience and findings in the literature.
| Study group | Role | What they receive |
|---|---|---|
| long-term high-risk drinking group | Experimental | First patient's use of Osselidin and next patient's use of Osselidin Receives: Other: long-term high-risk drinking |
| non-drinking group | Experimental | First patient's use of Osselidin and next patient's use of Osselidin Receives: Other: non-drinking |
What is being measured
The primary outcome is the main question the study is designed to answer.
ED₉₀ of the two groups
the effective doses of oliceridine for successful insertion of gastroscopy between long-term high-risk drinking and non-drinking patients.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion20 Dec 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Jiaxing University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qing-he Zhou, Affiliated Hospital of Jiaxing University
- Investigators
- Yazhi Xi, Principal investigator, Affiliated Hospital of Jiaxing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07880899
- Sponsor's protocol ID
- 2026-KY-478
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Long-term High-risk Drinking on the 90% Effective Dose of Osselidin in Adult Males Undergoing Painless Gastroscopy
- ClinicalTrials.gov ID
- NCT07880899
- Acronym / sponsor ID
- 2026-KY-478
- Conditions
- Sedation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Jiaxing UniversityUniversity, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 19 Oct 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 study aims to investigate the effect of chronic high-risk alcohol consumption on the effective dose of oliceridine combined with propofol for painless gastroscopy, so as to provide a reference for rational clinical medication.
Detailed description
The primary objective of our study is to use a biased coin up-down alloocation methology to estimate the dose of oliceridine combined with propofol for sedation of painless gastroscopy. Thus, this study was designed to compare the effective doses of oliceridine for successful insertion of gastroscopy between long-term high-risk drinking and non-drinking patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| long-term high-risk drinking group | Experimental | Other: long-term high-risk drinkingFirst patient's use of Osselidin and next patient's use of Osselidin |
| non-drinking group | Experimental | Other: non-drinkingFirst patient's use of Osselidin and next patient's use of Osselidin |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- This study enrolled patients undergoing elective painless gastroscopy, aged 18-64 years, with American Society of Anesthesiologists (ASA) physical status classification I-II, and body mass index (BMI) of 18-27 kg/m².
Key exclusion criteria (2 listed)
- Difficult airway (modified Mallampati grade IV); poorly controlled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg); hepatic or renal insufficiency, liver cirrhosis, significant organ dysfunction, severe cardiovascular disease, or arrhythmia; history of long-term use of sedatives, antipsychotics or analgesics; signs of alcohol withdrawal or alcohol addiction (e.g., inability to reduce alcohol intake despite obvious harmful effects, or morning tremors relieved by alcoholic beverages); mental disorders that impede proper self-expression; allergy to study-related medications or acute-phase asthma medications; known or suspected gastrointestinal obstruction; pregnancy or lactation, etc.
- Exclusion of cases: prolonged examination time due to difficult endoscopic manipulation; severe complications requiring emergency treatment such as hypoxemia and circulatory fluctuation, which violate the study protocol.
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 |
|---|---|---|
| long-term high-risk drinkingIf a patient had failed gastroscope insertion, the next patient would receive a higher dose (an increasing of 1.5 μg/kg). However, if a patient had successful gastroscpe insertion, the next patient would receive a lower dose (a decreasing of 1.5 μg/kg) with a probability of approximately B ≈ 0.11 (i.e., 1/9), or the same dose with a probability of 1 - B = 0.89 (i.e., 8/9). The initial dosage of oliceridine was set at 13 μg/kg, with an up-down dose of 1.5 μg/kg, based on our hospital's experience and findings in the literature. | Other | long-term high-risk drinking group |
| non-drinkingIf a patient had failed gastroscope insertion, the next patient would receive a higher dose (an increasing of 1.5 μg/kg). However, if a patient had successful gastroscpe insertion, the next patient would receive a lower dose (a decreasing of 1.5 μg/kg) with a probability of approximately B ≈ 0.11 (i.e., 1/9), or the same dose with a probability of 1 - B = 0.89 (i.e., 8/9). The initial dosage of oliceridine was set at 13 μg/kg, with an up-down dose of 1.5 μg/kg, based on our hospital's experience and findings in the literature. | Other | non-drinking group |
Primary outcome
ED₉₀ of the two groups
Time frame: 30 minutes
the effective doses of oliceridine for successful insertion of gastroscopy between long-term high-risk drinking and non-drinking patients.
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 19 Oct 2026.
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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.
Yazhi Xi principal investigator
Affiliated Hospital of Jiaxing 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 long-term high-risk drinking and non-drinking in people with Sedation, run by Affiliated Hospital of Jiaxing University 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 1 inclusion and 2 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 19 Oct 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 Yazhi Xi (15536368031, xiyazhi1996@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ED₉₀ of the two groups (time frame: 30 minutes). 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 19 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.