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
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