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Trial record 24 of 658 for:    Sevoflurane

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

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ClinicalTrials.gov Identifier: NCT03595319
Recruitment Status : Recruiting
First Posted : July 23, 2018
Last Update Posted : October 30, 2018
Sponsor:
Information provided by (Responsible Party):
Gabriel Magalhaes Nunes Guimaraes, Brasilia University Hospital

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.

Condition or disease Intervention/treatment Phase
Hypotension Drug: Sevoflurane Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
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.

Masking: Single (Participant)
Masking Description: Participant will not know allocation (sevoflurane concentration) and will be under general anesthesia
Primary Purpose: Basic Science
Official Title: Comparison of Median Alveolar Sevoflurane Concentration for Hypotension Between Young and Elderly Patients: Adaptive Clinical Trial
Actual Study Start Date : July 23, 2018
Actual Primary Completion Date : October 1, 2018
Estimated Study Completion Date : February 15, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Sevoflurane

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)




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Systolic hypotension [ Time Frame: During the first 10 minutes after end tidal sevoflurane concentration stabilizes ]
    Systolic arterial pressure drop >10%

  2. Diastolic hypotension [ Time Frame: During the first 10 minutes after end tidal sevoflurane concentration stabilizes ]
    Systolic arterial pressure drop >10%



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03595319


Contacts
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Contact: Gabriel MN Guimarães, MD, MSc +5561996455997 gguimaraes@unb.br

Locations
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Brazil
Hospital Universitário de Brasilia Recruiting
Brasilia, Distrito Federal, Brazil, 70000000
Contact: Gabriel MN Guimarães, MD, MsC    +5561996455997    gabrielmng@gmail.com   
Principal Investigator: Gabriel MN Guimarães, Md, MSc         
Sponsors and Collaborators
Brasilia University Hospital
Investigators
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Principal Investigator: Gabriel MN Guimarães, MD, MSc University of Brasilia

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Responsible Party: Gabriel Magalhaes Nunes Guimaraes, Head of Anesthesiology, Brasilia University Hospital
ClinicalTrials.gov Identifier: NCT03595319     History of Changes
Other Study ID Numbers: TccFeliciaVictor2018
First Posted: July 23, 2018    Key Record Dates
Last Update Posted: October 30, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Plan to share unidentified individual patient data in mendeley data.
Supporting Materials: 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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gabriel Magalhaes Nunes Guimaraes, Brasilia University Hospital:
Hypotension
Sevoflurane
Elderly

Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases
Sevoflurane
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs