Determination of Remifentanil's ED50 for Rapid Sequence Intubation Avoiding Bradycardia and Hypotension in Adults

September 12, 2017 updated by: Gabriel Magalhaes Nunes Guimaraes, Brasilia University Hospital
This study will find the median effective dose of remifentanil for rapid sequence intubation which avoids bradycardia and hypotension

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Remifentanil is becoming popular for rapid sequence intubation because it has a fast onset and ultra-short half-life.

Remifentanil a potent opioid associated to bradycardia and hypotension at high doses.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 3

Contacts and Locations

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

Study Locations

  • Brazil
    • Distrito Federal
      • Brasilia, Distrito Federal, Brazil, 70000000
        • Hospital das Forças Armadas

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Indication of anesthesia induction

Exclusion Criteria:

  • Protocol violation
  • Monitoring problems

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Arm
Patients will receive bolus dose of remifentanil before intubation
Drug: Remifentanil
bolus dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hemodynamic stability during rapid sequence intubation
Time Frame: from anesthesia induction up to 5 minutes
no bradycardia and no hypotension
from anesthesia induction up to 5 minutes

Collaborators and Investigators

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

Sponsor

Brasilia University Hospital

Investigators

  • Study Director: Gabriel MN Guimarães, MSc, Head of Anesthesiology

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)

February 25, 2017

Primary Completion (Actual)

February 28, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

February 22, 2017

First Submitted That Met QC Criteria

February 24, 2017

First Posted (Actual)

February 27, 2017

Study Record Updates

Last Update Posted (Actual)

September 13, 2017

Last Update Submitted That Met QC Criteria

September 12, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TCC-Lara-2017

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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