N/A
Completed N=165
ED90 of Remimazolam Anesthesia Induction in Painless Bidirectional Endoscopy in Children
Bidirectional Endoscopy
Source: ClinicalTrials.gov NCT06121609 ↗
Enrolled (actual)
165
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcomePrimary: Modified Observer's Assessment of Alertness/Sedation Scale, MOAA/S — 0.674; 0.449; 0.937 units on a scale
Summary
Exploring the ED90 of remimazolam in pediatric bidirectional endoscopy at different age groups.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Modified Observer's Assessment of Alertness/Sedation Scale, MOAA/S |
0.674; 0.449; 0.937 | — |
| SECONDARY Respiratory Suppression Incidence |
4; 7; 2 | — |
| SECONDARY Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] |
0; 0; 0 | — |
| SECONDARY Time Records |
120; 100; 150 | — |
Eligibility Criteria
Inclusion Criteria
- Age 0-12 years old,
- ASA I-II level;
- Sign an informed consent form.
Exclusion Criteria
- Developmental delay or neurological and psychiatric disorders;
- Severe malnutrition or severe obesity;
- High risk of stomach fullness and reflux aspiration;
- Allergic to benzodiazepines and opioids;
- Those who have taken sedative, analgesic, or antidepressant drugs within 24 hours;
- Severe sleep apnea;
- Abnormal liver and kidney function;
- Recently participated in other clinical studies.
Data sourced from ClinicalTrials.gov (NCT06121609). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.