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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05686863
Other study ID # RECES
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 18, 2023
Est. completion date July 7, 2023

Study information

Verified date August 2023
Source Tongji Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 106
Est. completion date July 7, 2023
Est. primary completion date July 7, 2023
Accepts healthy volunteers No
Gender All
Age group 1 Month to 17 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Remimazolam
Remazolam for sedation in children undergoing bidirectional endoscopy
Esketamine
Esketamine
Propofol
Propofol
remifentanil
remifentanil

Locations

Country Name City State
China Tongji Hospital Wuhan Hubei

Sponsors (1)

Lead Sponsor Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sedation success rate Improved observer alertness and sedation score, MOAA/S Procedure (From the beginning of anesthesia to the end of examination)
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