Dose of Remimazolam in Children for Intubation (DRIP)

December 12, 2023 updated by: Zhihong LU

Half Effective Dose of Remimazolam to Prevent Cardiovascular Response to Tracheal Intubation When Combined With Fentanyl

Remimazolam has demonstrated the potential as a valuable medication for procedural sedation and general anesthesia. However, half effective dose of remimazolam required to prevent cardiovascular response to tracheal intubation when combined with fentanyl in pediatric patients is still unknown.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

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
  • Body mass index in the range of 5% -95% of the same age group
  • Consent was obtained from the patient and the family members, and an informed consent form was signed

Exclusion Criteria:

  • American Society of Anesthesiologists status ≥3
  • patients who cannot cooperate with intravenous anesthesia induction
  • patients with risk of difficult airway
  • patients who are allergic to benzodiazepines
  • patients with neurological dysfunction
  • Participate involved in other clinical investigators within 3 months

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. The initial dosage is 0.4mg/kg, and the interval dosage is 0.02mg/kg.
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 dose for intubation
Time Frame: from injection of remimazolam to completed tracheal intubation, at an average of 5 minutes
half effective dose of remimazolam required to prevent cardiovascular response to tracheal intubation when combined with fentanyl
from injection of remimazolam to completed tracheal intubation, at an average of 5 minutes
cardiovascular response to tracheal intubation
Time Frame: from injection of remimazolam to 3 minutes after tracheal intubation, at an average of 8 minutes
cardiovascular response is defined as increase of blood pressure or heart rate higher than 20% of the baseline value by 3 minutes after intubation
from injection of remimazolam to 3 minutes after tracheal intubation, at an average of 8 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the time to loss of consciousness
Time Frame: from injection of remimazolam to loss of consciousness, at an average of 3 minutes
from injection of remimazolam to loss of consciousness, at an average of 3 minutes
incidence of adverse events
Time Frame: from injection of remimazolam to loss of consciousness, at an average of 3 minutes
adverse events include bradycardia, hypotension, hypoxemia, and injection pain
from injection of remimazolam to loss of consciousness, at an average of 3 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)

December 20, 2023

Primary Completion (Estimated)

May 31, 2024

Study Completion (Estimated)

May 31, 2024

Study Registration Dates

First Submitted

November 30, 2023

First Submitted That Met QC Criteria

December 12, 2023

First Posted (Estimated)

December 14, 2023

Study Record Updates

Last Update Posted (Estimated)

December 14, 2023

Last Update Submitted That Met QC Criteria

December 12, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • XJH-A-20231120

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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