Dose of Remi in Children (DRINK)

August 7, 2023 updated by: Zhihong LU

Determination of the 50% and 95% Effective Dose of Remimazolam for Intravenous Anesthesia Induction in Pediatric Patients

Remimazolam has demonstrated the potential as a valuable medication for procedural sedation and general anesthesia. However, the effective dosage of remimazolam in pediatric patients is still unknown.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

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

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • age from 3 to 12 years old
  • patients scheduled for surgery under general anesthesia

Exclusion Criteria:

  • American Society of Anesthesiologists status >=Ⅲ
  • Body mass index>=28kg/m2
  • patients who cannot cooperate with intravenous anesthesia induction
  • patients with risk of difficult airway
  • patients who are allergic to benzodiazepines
  • patients with delayed neurologic function

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: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: remimazolam
remimazolam is given for anesthesia induction
Drug: Remimazolam
remimazolam is given intravenously
Other Names:
  • remimazolam besylate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
half effective dosage
Time Frame: from injection of remimazolam to loss of consciousness, at an average of 5 minutes
the dosage by which half of the patients will be sedated
from injection of remimazolam to loss of consciousness, at an average of 5 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
95% effective dosage
Time Frame: from injection of remimazolam to loss of consciousness, at an average of 5 minutes
the dosage by which 95% of the patients will be sedated
from injection of remimazolam to loss of consciousness, at an average of 5 minutes

Collaborators and Investigators

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

Sponsor

Zhihong LU

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

August 10, 2023

Primary Completion (Estimated)

September 10, 2023

Study Completion (Estimated)

September 10, 2023

Study Registration Dates

First Submitted

August 7, 2023

First Submitted That Met QC Criteria

August 7, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 7, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • XJH-A-20230606

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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