Back to resultsDetermination of Remifentanil's ED50 for Rapid Sequence Intubation Avoiding Bradycardia and Hypotension in Adults
Primary Purpose
Bradycardia, Hypotension
Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Remifentanil
Sponsored by
About this trial
This is an interventional supportive care trial for Bradycardia
Eligibility Criteria
Inclusion Criteria:
- Indication of anesthesia induction
Exclusion Criteria:
- Protocol violation
- Monitoring problems
Sites / Locations
- Hospital das Forças Armadas
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Arm
Arm Description
Patients will receive bolus dose of remifentanil before intubation
Outcomes
Primary Outcome Measures
hemodynamic stability during rapid sequence intubation
no bradycardia and no hypotension
Secondary Outcome Measures
Full Information
NCT ID
NCT03065309
First Posted
February 22, 2017
Last Updated
September 12, 2017
Sponsor
Brasilia University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03065309
Brief Title
Determination of Remifentanil's ED50 for Rapid Sequence Intubation Avoiding Bradycardia and Hypotension in Adults
Official Title
Determination of Remifentanil's ED50 for Rapid Sequence Intubation Avoiding Bradycardia and Hypotension in Adults
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
February 25, 2017 (Actual)
Primary Completion Date
February 28, 2017 (Actual)
Study Completion Date
March 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brasilia University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will find the median effective dose of remifentanil for rapid sequence intubation which avoids bradycardia and hypotension
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bradycardia, Hypotension
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Sequential Assignment
Model Description
Adaptative clinical trial, Dixon's Up-And-Down Method
Masking
None (Open Label)
Masking Description
Participant will receive propofol before induction
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Experimental
Arm Description
Patients will receive bolus dose of remifentanil before intubation
Intervention Type
Drug
Intervention Name(s)
Remifentanil
Intervention Description
bolus dose
Primary Outcome Measure Information:
Title
hemodynamic stability during rapid sequence intubation
Description
no bradycardia and no hypotension
Time Frame
from anesthesia induction up to 5 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Indication of anesthesia induction
Exclusion Criteria:
Protocol violation
Monitoring problems
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriel MN Guimarães, MSc
Organizational Affiliation
Head of Anesthesiology
Official's Role
Study Director
Facility Information:
Facility Name
Hospital das Forças Armadas
City
Brasilia
State/Province
Distrito Federal
ZIP/Postal Code
70000000
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Determination of Remifentanil's ED50 for Rapid Sequence Intubation Avoiding Bradycardia and Hypotension in Adults
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