Study pinpoints ideal sedative dose for kids' scope procedures
NCT ID NCT06121609
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study aimed to find the most effective dose of remimazolam, a sedative, for children aged 0-12 undergoing painless bidirectional endoscopy. Researchers tested different doses in 165 children to see which level safely and reliably produced adequate sedation. The goal is to improve sedation practices for pediatric endoscopic procedures.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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165 people
The number who actually took part.
- Started
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Jan 2024
- Finished
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Apr 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Up to 12 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age 0-12 years old, 2. ASA I-II level; 3. Sign an informed consent form. Exclusion Criteria: 1. Developmental delay or neurological and psychiatric disorders; 2. Severe malnutrition or severe obesity; 3. High risk of stomach fullness and reflux aspiration; 4. Allergic to benzodiazepines and opioids; 5. Those who have taken sedative, analgesic, or antidepressant drugs within 24 hours; 6. Severe sleep apnea; 7. Abnormal liver and kidney function; 8. Recently participated in other clinical studies.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Tongji Hospital
Wuhan, Hubei, 430000, China