Remiazolam Combined With Esketamine in Painless Bidirectional Endoscopy in Children

Drug Effect Clinical Trial

Official title:

Sedative Effect and Safety of Remiazolam Combined With Low-dose Esketamine in Painless Bidirectional Endoscopy in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05686863
• Other study ID #: RECES
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Drug Effect

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)