NCT07083440

Varied Remimazolam Dosages for Pediatric Endoscopy

A Clinical Investigation of Varied Remimazolam Dosages With Sufentanil and Propofol for Painless Pediatric Gastrointestinal Endoscopy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Children's Hospital of Hebei Province · Academic / Other
• Sex: All
• Age: 3 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

This prospective, randomized, comparative study aims to compare the efficacy and safety of three different doses of remimazolam (0.2 mg/kg, 0.3 mg/kg, and 0.4 mg/kg) combined with sufentanil and propofol for painless gastroscopy in pediatric patients. The study will assess sedation quality, propofol consumption, hemodynamic stability, and adverse event profiles to identify an optimal remimazolam dosing regimen.

Detailed description

Pediatric patients undergoing gastrointestinal endoscopy often require deep sedation. Propofol is commonly used but can cause injection pain, respiratory depression, and hemodynamic instability. Remimazolam, a novel ultra-short-acting benzodiazepine, offers rapid onset, predictable recovery, and potentially better hemodynamic stability. This study investigates three doses of remimazolam (0.2 mg/kg, 0.3 mg/kg, and 0.4 mg/kg) co-administered with sufentanil (0.1 µg/kg) and titrated propofol to achieve a Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score ≤ 2 in 180 pediatric patients (ASA I-II, aged \<18 years) undergoing gastroscopy. Patients are randomly assigned to one of three remimazolam dose groups. The study will evaluate total propofol dosage, hemodynamic changes (blood pressure, heart rate), time to sedation, awakening and recovery times, incidence of adverse events (e.g., hypotension, respiratory depression, injection pain), and satisfaction scores. The goal is to determine a remimazolam dose that provides effective sedation with reduced propofol requirements and an improved safety profile.

Conditions

• Gastrointestinal Diseases

Interventions

Type	Name	Description
DRUG	Remimazolam	Intravenous bolus administered over 1 minute (prepared as a 1 mg/mL solution). Doses: 0.2 mg/kg, 0.3 mg/kg, or 0.4 mg/kg according to group allocation.
DRUG	Propofol	Intravenous (10 mg/mL emulsion), initial titrated dose ranging from 0.5 to 2 mg/kg, administered slowly until MOAA/S ≤ 2. Supplemental 0.5 mg/kg boluses as needed.
DRUG	Sufentanil	Intravenous dose of 0.1 µg/kg administered approximately 30 minutes before the start of the procedure.

Timeline

• Start date: 2023-06-01
• Primary completion: 2024-05-01
• Completion: 2024-05-01
• First posted: 2025-07-24
• Last updated: 2025-07-24

Locations

1 site across 1 country: China