Determination of Remifentanil's ED50 for Rapid Sequence I... | NCT03065309

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

NCT03065309

Sponsor

Brasilia University Hospital

Status

Completed

Last Update Posted

Sep 13, 2017Actual

Enrollment

15Actual

Phase

Phase 3

Conditions

Bradycardia
Hypotension

Interventions

Remifentanil

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 25, 2017Actual

Primary Completion Date

Feb 28, 2017Actual

Completion Date

Mar 1, 2017Actual

First Submitted Date

Feb 22, 2017

First Submission Date that Met QC Criteria

Feb 24, 2017

First Posted Date

Feb 27, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 12, 2017

Last Update Posted Date

Sep 13, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Gabriel Magalhaes Nunes Guimaraes, Head of Anesthesia department, Brasilia University HospitalPrincipal Investigator

Lead Sponsor

Brasilia University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single Arm	Experimental	Patients will receive bolus dose of remifentanil before intubation	Drug: Remifentanil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Remifentanil	Drug	bolus dose	Single Arm

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Indication of anesthesia induction

Exclusion Criteria:

Protocol violation
Monitoring problems

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gabriel MN Guimarães, MSc	Head of Anesthesiology	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital das Forças Armadas		Brasília	Federal District	70000000	Brazil

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001919	Bradycardia
D007022	Hypotension

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077208	Remifentanil

Ancestor Terms

ID	Term
D011422	Propionates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided