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Comparison of efficacy and safety of Afentanil, oxelidine fumarate, Sufentanil combined with etomidate and propofol in painless gastroscopy

Comparison of efficacy and safety of Afentanil, oxelidine fumarate, Sufentanil combined with etomidate and propofol in painless gastroscopy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500098772
Enrollment
Unknown
Registered
2025-03-13
Start date
2025-04-15
Completion date
Unknown
Last updated
2025-03-17

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

Conditions

painless gastroscopy

Interventions

Afentanil group (Group A):10ug/kg afentanil +0.15-0.2ml/kg EP mixture (etomidate 20mg and 1% propofol 200mg
Osselidine Group (Group O):0.03mg/kg oxelidine +0.15-0.2ml/kg EP mixture (etomidate 20mg and 1% propofol 200mg)
Sufentanil group (S group):0.1ug/kg Sufentanil +0.15-0.2ml/kg EP mixture (etomidate 20mg, 1% propofol 200mg)

Sponsors

Yanting County People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Patients who intend to undergo painless gastroscopy and voluntarily participate in the study and sign the informed consent form, aged 18-60 years, with a BMI of 18-28 kg/m², and ASA grade I or II.

Exclusion criteria

Exclusion criteria: 1. Those who have cognitive dysfunction in the past, suffer from mental illness, and have communication difficulties; 2. Those with a history of alcohol or drug abuse; 3. Those who use anesthetic drugs, sedatives or opioids 24 hours before surgery; 4. Those who have participated in any clinical trial as a subject within 3 months before selection; 5. Those who are allergic or hypersensitive to the drugs used in the study; 6. Pregnant or lactating women or patients with birth plans within 3 months; 7. Patients with symptoms of acute upper gastrointestinal bleeding or need gastroscopy treatment; 8. Patients who require complex endoscopic techniques for diagnosis and treatment; 9. Those who intend to undergo tracheal intubation; 10. People who are judged to have difficulty in respiratory tract management.

Design outcomes

Primary

MeasureTime frame
Incidence of respiratory depression;

Secondary

MeasureTime frame
Respiratory circulatory index;Total amount of propofol used;The interval between the start of administration and the disappearance of eyelash reflexes;The interval between discontinuation of administration and instruction to open eyes after surgery;The interval between withdrawal and discharge;Patient's sedation level at 5-minute intervals within 20 minutes of discontinuation;Incidence of nausea and vomiting;All adverse reactions occurred during and after surgery;

Countries

China

Contacts

Public ContactJiayan Luo

Yanting County People's Hospital

765503701@qq.com+86 13 558 995 2572

Outcome results

None listed

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