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

Primary Purpose

Hypotension

Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Sevoflurane
Sponsored by
Brasilia University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hypotension focused on measuring Hypotension, Sevoflurane, Elderly

Eligibility Criteria

19 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Hospital Universitário de BrasiliaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Young patients

Elder patients

Arm Description

Patients between 19 and 40 years-old

Older than 65

Outcomes

Primary Outcome Measures

Hypotension incidence related to sevoflurane
Any mean arterial pressure drop > 10% compared to baseline

Secondary Outcome Measures

Systolic hypotension
Systolic arterial pressure drop >10%
Diastolic hypotension
Systolic arterial pressure drop >10%

Full Information

First Posted
July 12, 2018
Last Updated
October 27, 2018
Sponsor
Brasilia University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03595319
Brief Title
Median Sevoflurane Concentration for Hypotension Between Young and Elderlypatients: Adaptive Clinical Trial
Official Title
Comparison of Median Alveolar Sevoflurane Concentration for Hypotension Between Young and Elderly Patients: Adaptive Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 23, 2018 (Actual)
Primary Completion Date
October 1, 2018 (Actual)
Study Completion Date
February 15, 2019 (Anticipated)

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension
Keywords
Hypotension, Sevoflurane, Elderly

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Sequential Assignment
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.
Masking
Participant
Masking Description
Participant will not know allocation (sevoflurane concentration) and will be under general anesthesia
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Young patients
Arm Type
Experimental
Arm Description
Patients between 19 and 40 years-old
Arm Title
Elder patients
Arm Type
Experimental
Arm Description
Older than 65
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Intervention Description
Inhaled sevoflurane until allocated dose (see adaptive protocol)
Primary Outcome Measure Information:
Title
Hypotension incidence related to sevoflurane
Description
Any mean arterial pressure drop > 10% compared to baseline
Time Frame
During the first 10 minutes after end tidal sevoflurane concentration stabilizes
Secondary Outcome Measure Information:
Title
Systolic hypotension
Description
Systolic arterial pressure drop >10%
Time Frame
During the first 10 minutes after end tidal sevoflurane concentration stabilizes
Title
Diastolic hypotension
Description
Systolic arterial pressure drop >10%
Time Frame
During the first 10 minutes after end tidal sevoflurane concentration stabilizes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gabriel MN Guimarães, MD, MSc
Phone
+5561996455997
Email
gguimaraes@unb.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriel MN Guimarães, MD, MSc
Organizational Affiliation
University of Brasilia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitário de Brasilia
City
Brasilia
State/Province
Distrito Federal
ZIP/Postal Code
70000000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriel MN Guimarães, MD, MsC
Phone
+5561996455997
Email
gabrielmng@gmail.com
First Name & Middle Initial & Last Name & Degree
Gabriel MN Guimarães, Md, MSc

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Plan to share unidentified individual patient data in mendeley data.
IPD Sharing Time Frame
Up until mendeley data can host
IPD Sharing Access Criteria
Open access
IPD Sharing URL
http://www.anestesiologiaunb.com.br

Learn more about this trial

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

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