Remiazolam Combined With Esketamine in Painless Bidirectional Endoscopy in Children

August 16, 2023 updated by: aijun xu, Tongji Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Tongji Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 17 years (Child)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
Drug: Propofol
Propofol
Other Names:
  • Prop
Drug: remifentanil
remifentanil
Other Names:
  • remifen
Drug: Esketamine
Esketamine
Other Names:
  • Esket
Experimental: 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
Drug: remifentanil
remifentanil
Other Names:
  • remifen
Drug: Esketamine
Esketamine
Other Names:
  • Esket
Drug: Remimazolam
Remazolam for sedation in children undergoing bidirectional endoscopy
Other Names:
  • Rema

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sedation success rate
Time Frame: Procedure (From the beginning of anesthesia to the end of examination)
Improved observer alertness and sedation score, MOAA/S
Procedure (From the beginning of anesthesia to the end of examination)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tongji Hospital

Investigators

  • Study Director: Hong Liu, Dr, Tongji Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2023

Primary Completion (Actual)

July 7, 2023

Study Completion (Actual)

July 7, 2023

Study Registration Dates

First Submitted

January 7, 2023

First Submitted That Met QC Criteria

January 13, 2023

First Posted (Actual)

January 17, 2023

Study Record Updates

Last Update Posted (Actual)

August 21, 2023

Last Update Submitted That Met QC Criteria

August 16, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECES

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Research data can be requested from the main researchers via email

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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