Remiazolam Combined With Esketamine in Painless Bidirectional Endoscopy in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-18

Study Completion Date

2023-07-07

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Drug Effect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, randomized controlled study

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

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

Study Groups

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P group

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

Group Type ACTIVE_COMPARATOR

Esketamine

Intervention Type DRUG

Esketamine

Propofol

Intervention Type DRUG

Propofol

remifentanil

Intervention Type DRUG

remifentanil

R group

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

Group Type EXPERIMENTAL

Remimazolam

Intervention Type DRUG

Remazolam for sedation in children undergoing bidirectional endoscopy

Esketamine

Intervention Type DRUG

Esketamine

remifentanil

Intervention Type DRUG

remifentanil

Interventions

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Remimazolam

Remazolam for sedation in children undergoing bidirectional endoscopy

Intervention Type DRUG

Esketamine

Intervention Type DRUG

Propofol

Intervention Type DRUG

remifentanil

Intervention Type DRUG

Other Intervention Names

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Rema Esket Prop remifen

Eligibility Criteria

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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.

Minimum Eligible Age

1 Month

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No