NCT03065309

Brief Summary

This study will find the median effective dose of remifentanil for rapid sequence intubation which avoids bradycardia and hypotension

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

February 25, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 27, 2017

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2017

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

September 13, 2017

Status Verified

September 1, 2017

Enrollment Period

3 days

First QC Date

February 22, 2017

Last Update Submit

September 12, 2017

Conditions

BradycardiaHypotension

Outcome Measures

Primary Outcomes (1)

  • hemodynamic stability during rapid sequence intubation

    no bradycardia and no hypotension

    from anesthesia induction up to 5 minutes

Study Arms (1)

Single Arm

EXPERIMENTAL

Patients will receive bolus dose of remifentanil before intubation

Drug: Remifentanil

Interventions

RemifentanilDRUG

bolus dose

Single Arm

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Indication of anesthesia induction

You may not qualify if:

  • Protocol violation
  • Monitoring problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital das Forças Armadas

Brasília, Federal District, 70000000, Brazil

Location

MeSH Terms

Conditions

BradycardiaHypotension

Interventions

Remifentanil

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsVascular Diseases

Intervention Hierarchy (Ancestors)

PropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Gabriel MN Guimarães, MSc

    Head of Anesthesiology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Masking
NONE
Masking Details
Participant will receive propofol before induction
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Model Details: Adaptative clinical trial, Dixon's Up-And-Down Method
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Anesthesia department

Study Record Dates

First Submitted

February 22, 2017

First Posted

February 27, 2017

Study Start

February 25, 2017

Primary Completion

February 28, 2017

Study Completion

March 1, 2017

Last Updated

September 13, 2017

Record last verified: 2017-09

Locations

BR(1)