Remifentanil Minimum Effective Dose for Children Intubation Without Neuromuscular Blockade

July 18, 2016 updated by: Gabriel Magalhaes Nunes Guimaraes, Brasilia University Hospital
Introduction: remifentanil's optimal dose for children intubation without neuromuscular blockade is unknown. Method: phase IV adaptative trial using Dixon's up-and-down method for modeling remifentanil's dose-response curve for adequate intubation conditions as defined by previous studies.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Introduction: remifentanil's optimal dose for children intubation without neuromuscular blockade is unknown.

Method: phase IV adaptative trial using Dixon's up-and-down method for modeling remifentanil's dose-response curve for adequate intubation conditions as defined by previous studies. Remifentanil doses starting from 2mg/kg will be infused before intubation. When a success occurs next patient's dose will be decreased by 0.25mg/kg/h. When a success does not occur the next patient's dose will be increased by 0.25mg/kg/h. Intubation will be considered adequate if patient does not cough, does not move, if vocal cords are open, if larigocsocpic Cormack grade I or II.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

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

2 years to 9 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA I or II
  • Scheduled for surgery under general anesthesia.

Exclusion Criteria:

  • Predicted difficult airway
  • Severe neurologic or cardiologic conditions
  • Recent upper airway infectious diseases

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: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study arm
There is a single study arm. Remifentanil will be infused before intubation. The first patient will receive remifentanil 2mg/kg. If a success occurs the next patient's dose will be decreased by 0.25mg/kg and else it will be increased by 0.25mg/kg. This rule will apply recursively as Dixon's Up-And-Down Method.
Drug: Remifentanil
Remifentanil for intubation without neuromuscular blockade
Other Names:
  • Ultiva

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Adequate intubation condition (dichotomic) as an assessment of success rate
Time Frame: intraoperative
Intubation is adequate if patient does not cough, does not try to breathe, vocal cords do not move, patient does not react and laringoscopy is Cormack class I or II
intraoperative

Collaborators and Investigators

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

Sponsor

Brasilia University Hospital

Collaborators

University of Brasilia

Investigators

  • Principal Investigator: Catia S Goveia, MSc, University of Brasilia

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

July 1, 2016

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

May 14, 2015

First Submitted That Met QC Criteria

May 26, 2015

First Posted (Estimate)

May 27, 2015

Study Record Updates

Last Update Posted (Estimate)

July 19, 2016

Last Update Submitted That Met QC Criteria

July 18, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UBrasilia

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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