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Not yet recruitingNCT07880899Updated Oct 19, 2026

The Impact of Long-term High-risk Drinking on the Effective Dose of Osselidin

An interventional study of long-term high-risk drinking and non-drinking in Sedation, sponsored by Affiliated Hospital of Jiaxing University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-10-19.

Sponsored by Affiliated Hospital of Jiaxing University · Not applicable, Interventional, and Treatment

Updated Oct 19, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Sedation
03

In context

Lead sponsor

Affiliated Hospital of Jiaxing University is the lead sponsor of 17 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • This study enrolled patients undergoing elective painless gastroscopy, aged 18-64 years, with (ASA) physical status classification I-II, and (BMI) of 18-27 kg/m².

Exclusion criteria

Exclusion Criteria:

  • 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.

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Investigator)
Enrollment
110 participants (estimated)

Study arms

  • Experimental
    long-term high-risk drinking group

    First patient's use of Osselidin and next patient's use of Osselidin

    Other: long-term high-risk drinking

  • Experimental
    non-drinking group

    First patient's use of Osselidin and next patient's use of Osselidin

    Other: non-drinking

Interventions

  • Otherlong-term high-risk drinking

    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.

  • Othernon-drinking

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 30 minutes

07

Study locations

1 site
08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 19, 2026
Show all 1 update
  1. Oct 19, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07880899
Lead sponsor
Affiliated Hospital of Jiaxing University
Responsible party
Qing-he Zhou (President, Affiliated Hospital of Jiaxing University) — Principal investigator
First posted
Oct 19, 2026
Start date
Oct 15, 2026 (estimated)
Primary completion
Dec 20, 2026 (estimated)
Completion
Dec 20, 2026 (estimated)
Last update
Oct 19, 2026

Study contacts

Yazhi Xi
Contact
xiyazhi1996@163.com
15536368031
Yazhi Xi
principal investigator · Affiliated Hospital of Jiaxing University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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