Drug Effect
Conditions
Keywords
remiazolam, esketamine, bidirectional endoscopy, children
Brief summary
To observe the sedative effect and safety of remiazolam combined with small dose of esketamine in painless bidirectional endoscopy in children, and to provide a more reasonable and safe sedative and analgesic regimen for children's gastrointestinal endoscopy.
Detailed description
It is planned to observe the painless two-way endoscopic examination of children in Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology from November 2022 to May 2023.To observe the sedative effect and safety of remiazolam combined with small dose of esketamine in painless bidirectional endoscopy in children, and to provide a more reasonable and safe sedative and analgesic regimen for children's gastrointestinal endoscopy.
Interventions
DRUGRemimazolam
Remazolam for sedation in children undergoing bidirectional endoscopy
DRUGEsketamine
Esketamine
DRUGPropofol
Propofol
DRUGremifentanil
remifentanil
Sponsors
Tongji Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Since propofol is white uniform emulsion, and ramazolam is colorless, clear and transparent liquid, anesthesiologists and surgeons may see the color of the study drug during operation, so this study is a single blind clinical study
Intervention model description
Prospective, randomized controlled study
Eligibility
Sex/Gender
ALL
Age
1 Months to 17 Years
Healthy volunteers
No
Inclusion criteria
* Age 0-17; * ASA Class I-II; * Sign the informed consent form.
Exclusion criteria
* Patients with high risk of stomach satiety and reflux aspiration; * Patients allergic to the study drug; * Obesity or severe malnutrition; * Those who have taken sedative, analgesic or antidepressant drugs within 24 hours; * Hypertension without treatment; * Abnormal liver and kidney function (index ≥ 2 times the upper limit of normal reference range); * Other congenital diseases or acute and chronic diseases that affect the observation of curative effect; * Participate in other clinical studies within 4 weeks.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sedation success rate | Procedure (From the beginning of anesthesia to the end of examination) | Improved observer alertness and sedation score, MOAA/S |
Countries
China
Outcome results
None listed