Remiazolam Combined With Esketamine in Painless Bidirectional Endoscopy in Children

Tongji Hospital

Status: Completed

Conditions: Drug Effect

Treatments: Drug: Remimazolam; Drug: Esketamine; Drug: remifentanil; Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT05686863

RECES

Details and patient eligibility

About

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.

Full 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.

Enrollment: 106 patients

Sex: All

Ages: 1 month to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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106 participants in 2 patient groups

P group

Active Comparator group

Description:

induction: Propofol 3 mg/kg+Esketamine 0.25 mg/kg intravenously, mantainance: propofol 5-10 mg/kg/h+remifentanil 0.5-1 μg/kg/h continuous pumping

Treatment:

Drug: Propofol

Drug: remifentanil

Drug: Esketamine

R group

Experimental group

Description:

induction: Remimazolam 0.3 mg/kg+Esketamine 0.25 mg/kg intravenously, mantainance: Remimazolam 1-3 mg/kg/h+remifentanil 0.5-1 μg/kg/h continuous pumping

Treatment:

Drug: remifentanil

Drug: Esketamine

Drug: Remimazolam