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Dose-Response Study of Remimazolam Combined with Different Doses of Alfentanil for Sedation in Pediatric Gastroscopy

Dose-Response Study of Remimazolam Combined with Different Doses of Alfentanil for Sedation in Pediatric Gastroscopy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109979
Enrollment
Unknown
Registered
2025-09-28
Start date
2025-10-01
Completion date
Unknown
Last updated
2025-10-06

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

Conditions

Gastroscopy

Interventions

The low-dose alfentanil group:Alfentanil 5ug/kg was administered intravenously
The high-dose alfentanil group:Alfentanil 10ug/kg was administered intravenously

Sponsors

Qinghai Women and Children's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Age 6 to 12 years; 2. Children scheduled to undergo diagnostic gastroscopy under deep sedation or general anesthesia without endotracheal intubation; 3. American Society of Anesthesiologists (ASA) physical status classification I–II.

Exclusion criteria

Exclusion criteria: 1. Presence of congenital heart disease, recent upper respiratory infection, asthma exacerbation, or epilepsy; 2. Allergy to any of the experimental anesthetic agents used in the study; 3. Receiving treatment for underlying disease with surgery duration exceeding 30 minutes.

Design outcomes

Primary

MeasureTime frame
The effective dose of remimazolam for pediatric gastroscopy under anesthesia with different doses of alfentanil;

Secondary

MeasureTime frame
Adverse events (including respiratory depression, hypotension, bradycardia, laryngospasm, nausea, vomiting, and delirium);Cardiovascular and respiratory complications;

Countries

China

Contacts

Public ContactZhang Jinbao

Qinghai Women and Children's Hospital

374075924@qq.com+86 130 8628 9024

Outcome results

None listed

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