Median Sevoflurane Concentration for Hypotension Between... | NCT03595319

Studies
Median Sevoflurane Concentration for Hypotension Between Young and Elderlypatients: Adaptive Clinical Trial

NCT03595319

Sponsor

Brasilia University Hospital

Status

Unknown status

Last Update Posted

Oct 30, 2018Actual

Enrollment

40Estimated

Phase

Phase 4

Conditions

Hypotension

Interventions

Sevoflurane

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

Oct 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 23, 2018Actual

Primary Completion Date

Oct 1, 2018Actual

Completion Date

Feb 15, 2019Estimated

First Submitted Date

Jul 12, 2018

First Submission Date that Met QC Criteria

Jul 12, 2018

First Posted Date

Jul 23, 2018Actual

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

Oct 27, 2018

Last Update Posted Date

Oct 30, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Gabriel Magalhaes Nunes Guimaraes, Head of Anesthesiology, 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

Two arms: elder group, young group. Dixon's up and down adaptive methodology for ED50. Executed after Anesthesia induction for 10min without touching the patient after starting mechanical ventilation.

Detailed Description

This adaptive clinical trial will vary target end tidal sevoflurane by 0.4, then by 0.2 and by 0.1 thereafter in order to minimize sample size.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Young patients	Experimental	Patients between 19 and 40 years-old	Drug: Sevoflurane
Elder patients	Experimental	Older than 65	Drug: Sevoflurane

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sevoflurane	Drug	Inhaled sevoflurane until allocated dose (see adaptive protocol)	Elder patients Young patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hypotension incidence related to sevoflurane	Any mean arterial pressure drop > 10% compared to baseline	During the first 10 minutes after end tidal sevoflurane concentration stabilizes

Secondary Outcomes

Measure	Description	Time Frame
Systolic hypotension	Systolic arterial pressure drop >10%	During the first 10 minutes after end tidal sevoflurane concentration stabilizes
Diastolic hypotension	Systolic arterial pressure drop >10%

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Understands experiment, is voluntary, signs informed consent;
Does not take medication that influences arterial pressure;
Normotensive.

Exclusion Criteria:

Received any medication that influences arterial pressure before experiment;

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

120 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Gabriel MN Guimarães, MD, MSc	Contact	+5561996455997		gguimaraes@unb.br

Overall Officials

Name	Affiliation	Role
Gabriel MN Guimarães, MD, MSc	University of Brasilia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Universitário de Brasilia	Recruiting	Brasília	Federal District	70000000	Brazil

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Plan to share unidentified individual patient data in mendeley data.

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code

Time Frame

Up until mendeley data can host

Access Criteria

Open access

URL

http://www.anestesiologiaunb.com.br

Condition Browse Module

MeSH Terms

ID	Term
D007022	Hypotension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077149	Sevoflurane

Ancestor Terms

ID	Term
D008738	Methyl Ethers
D004987	Ethers
D009930	Organic Chemicals
D006845	Hydrocarbons, Fluorinated

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

Adaptive up and down methodology. Anesthesia will be induced using etomidate, rocuronium and remifentanil. After intubation and mechanical ventilation, a high fresh gas flow and variable vaporizer target concentration will be used to stabilize the patient's target end tidal sevoflurane in less than two minutes.

Each patient's target end tidal sevoflurane is determined by the concentration used in the previous patient of the same group and by the incidence of hypotension. If the previous patient suffered hypotension, next patient's target concentration will drop. If there was no hypotension, next patient's target concentration will rise. The first patient on each group will be 2%. Target end tidal will vary 0.4% until the first crossover, then drop to 0.2% until the second crossover and will vary 0.1% thereafter.