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Cypropofol combined with fentanyl in high-risk patients with hypoxia for gastroenteroscopic sedation

Cypropofol combined with fentanyl in high-risk patients with hypoxia for gastroenteroscopic sedation

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078575
Enrollment
Unknown
Registered
2023-12-12
Start date
2024-01-01
Completion date
Unknown
Last updated
2023-12-19

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

Conditions

high-risk patients with hypoxia

Interventions

Cypropofol Group:Cypropofol+fentanyl
Propofol group:Propofol+fentanyl

Sponsors

Zhejiang Xiaoshan Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Adults =18 years of age, proposed to undergo gastroenteroscopy (upper or lower gastrointestinal tract or both) under deep sedation at Xiaoshan Hospital, Zhejiang, China, with a combined risk of hypoxemia.

Exclusion criteria

Exclusion criteria: 1. Emergency surgery (upper gastrointestinal bleeding) or need for tracheal intubation (ESD or ERCP).2. Post-tracheotomy.3. Postoperative cervical spine or ankylosing spondylitis resulting in cervical lordosis limitation.4. Patients with pre-existing hypoxemia e.g. PaO2 <80mmHg or SPO2 <92%;5 Pregnancy status; 6. Hypersensitivity or contraindication to drugs such as opioids, propofol, and their components.

Design outcomes

Primary

MeasureTime frame
Incidence of SPO2 <92% between the start of sedation and the end of the procedure.;

Secondary

MeasureTime frame
PO2 reduction >5% of basal value;Number of cases in which SPO2 =90% and severe hypoxia (SPO2 =85%) occurred;Number of successful sedation cases (completed entire gastroscopy procedure, no sedation remedy given);Time to awakening (time from last dose until patient meets discharge criteria);Incidence of injection pain;

Countries

China

Contacts

Public ContactShengjie Yao

Zhejiang Xiaoshan Hospital

4375092@qq.com+86 189 6716 8550

Outcome results

None listed

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