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

NCT07880899 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2026-10-15
Last updated
2026-10-19

Condition(s) studied

Sedation

Investigational drug(s) / intervention(s)

long-term high-risk drinkingnon-drinking

long-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.

non-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.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
64 Years
Healthy volunteers
No
Inclusion Criteria: * 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. 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.

Primary outcome measure(s)

  • ED₉₀ of the two groups — 30 minutes
    the effective doses of oliceridine for successful insertion of gastroscopy between long-term high-risk drinking and non-drinking patients.

Trial sites (1)

FacilityCityRegionStatus
Affiliated Hospital of Jiaxing University Jiaxing Zhejiang
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07880899 on ClinicalTrials.gov ↗ ← All trials in China