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A Parallel, Double-Blind Control Study of the New and Traditional Protocols for Painless Gastroscopy of Remazolam Combined with Fentanyl in Children

A Parallel, Double-Blind Control Study of the New and Traditional Protocols for Painless Gastroscopy of Remazolam Combined with Fentanyl in Children

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080842
Enrollment
Unknown
Registered
2024-02-08
Start date
2023-10-10
Completion date
Unknown
Last updated
2024-02-11

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

Conditions

Children requiring painless gastroscopy

Interventions

Part 2:Remazolam and fentanyl:Intravenous ED95 doses of remazolam and fentanyl, Remedy: Add remazolam 0.1mg/kg each time, and do not add more than 5 times during the gastroscopy.
Part 2:Propofol and fentanyl:Intravenous propofol and fentanyl, Remedy: Add propofol 0.5mg/kg each time, during the gastroscopy, add no more than 5 times.
Part 1:Remazolam and fentanyl:Intravenous remazolam and fentanyl, Remedy: 0.5-2mg/kg (per session) of propofol for remedial sedation to complete endoscopy.

Sponsors

The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
7 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. ASA Level I, II 2. Aged 7-12 years old 3. Meet the weight standard: Seven-year-old boys/girls 18.5kg~35.5kg/17.6kg~32.0kg Eight-year-old boys/girls 20.3kg~41.5kg/19.2kg~36.7kg Nine-year-old boys/girls 22.0kg~47.2kg/20.9kg~42.5kg Ten-year-old boys/girls 23.9kg~52.9kg/22.9kg~49.6kg Eleven-year-old boys/girls 26.2kg~59.4kg/25.7kg~56.7kg Twelve-year-old boys/girls 29.0kg~66.8kg/29.3kg~61.9kg 4. Children requiring painless gastroscopy 5. Preoperative heart, lung, liver, kidney, and other functions are basically normal

Exclusion criteria

Exclusion criteria: 1. Allergic history of fentanyl, remazolam and propofol 2. Children with airway hyperresponsiveness disease 3. Children with difficult airway 4. Participating in other studies 5. Children with upper respiratory tract infection within 1 month 6. Children with severe gastrointestinal lesions requiring special treatment

Design outcomes

Primary

MeasureTime frame
Discharge time;

Secondary

MeasureTime frame
Time of recovery;Body motion rate;Hypotension;Hypoxemia;Injection pain;Endoscopist satisfaction;Refill times;

Countries

China

Contacts

Public ContactHan Lin

The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

nanlinhannansh@qq.com+86 15 868 710 8331

Outcome results

None listed

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