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

October 27, 2018 updated by: Gabriel Magalhaes Nunes Guimaraes, Brasilia University Hospital

Comparison of Median Alveolar Sevoflurane Concentration for Hypotension Between Young and Elderly Patients: Adaptive Clinical Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Gabriel MN Guimarães, MD, MSc
  • Phone Number: +5561996455997
  • Email: gguimaraes@unb.br

Study Locations

  • Brazil
    • Distrito Federal
      • Brasilia, Distrito Federal, Brazil, 70000000
        • Recruiting
        • Hospital Universitário de Brasília
        • Contact:
        • Principal Investigator:
          • Gabriel MN Guimarães, Md, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Young patients
Patients between 19 and 40 years-old
Drug: Sevoflurane
Inhaled sevoflurane until allocated dose (see adaptive protocol)
Experimental: Elder patients
Older than 65
Drug: Sevoflurane
Inhaled sevoflurane until allocated dose (see adaptive protocol)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brasilia University Hospital

Investigators

  • Principal Investigator: Gabriel MN Guimarães, MD, MSc, University of Brasilia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 23, 2018

Primary Completion (Actual)

October 1, 2018

Study Completion (Anticipated)

February 15, 2019

Study Registration Dates

First Submitted

July 12, 2018

First Submitted That Met QC Criteria

July 12, 2018

First Posted (Actual)

July 23, 2018

Study Record Updates

Last Update Posted (Actual)

October 30, 2018

Last Update Submitted That Met QC Criteria

October 27, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TccFeliciaVictor2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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 Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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