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Oselidine fumarate for painless gastroscopy and colonoscopy: A randomized, controlled, single-center clinical study

Oselidine fumarate for painless gastroscopy and colonoscopy: A randomized, controlled, single-center clinical study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102087
Enrollment
Unknown
Registered
2025-05-08
Start date
2025-07-10
Completion date
Unknown
Last updated
2025-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Painless gastroscopy and colonoscopy

Interventions

Experimental group:Oxelidine 1-2mg+ propofol 2mg/kg
Control group:The butorphanol group was given butorphanol 0.6mg (or 0.02mg/kg) + propofol 2mg/kg

Sponsors

Jintang County First People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18-50 years old, gender not limited; 2. Body mass index: 18.5-27.9kg/m ² 3. The ASA classification is grade I-II; 4. Inspection time <=60 minutes; 5. Patients who are scheduled to undergo gastroscopy and colonoscopy 6. Voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with contraindications to endoscopic operations or those who refuse anesthesia; 2. Those who have contraindications or allergies to the test drug or other anesthetic drugs; 3. Uncontrolled circulatory and respiratory system diseases that may threaten life, such as acute coronary syndrome, uncontrolled severe hypertension (systolic blood pressure >=180mmHg, diastolic blood pressure >=110mmHg), severe arrhythmia, heart failure, acute respiratory tract infection, asthma attack period, active massive hemoptysis Liver dysfunction (Child-Pugh grade C or above), acute upper gastrointestinal bleeding with shock, severe anemia (Hb<6g/dl), gastrointestinal obstruction with retention of gastric contents; 4. Patients who participated in other studies within 30 days; 5. The researcher believes that there are other reasons that make participation in this clinical trial inappropriate.

Design outcomes

Primary

MeasureTime frame
The incidence of adverse events of respiratory depression (SPO2<90%);

Secondary

MeasureTime frame
Hemodynamic indicators;The frequency of body movement and choking cough during the examination;Drug dosage;The number of additional doses of propofol;

Countries

China

Contacts

Public ContactLi Deyuan

Jintang County First People's Hospital

1839077375@qq.com+86 159 0819 8639

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026