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

Phase 4
Conditions
Hypotension
Interventions
Registration Number
NCT03595319
Lead Sponsor
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.

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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
40
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 & Design

Study Type
INTERVENTIONAL
Study Design
SEQUENTIAL
Arm && Interventions
GroupInterventionDescription
Elder patientsSevofluraneOlder than 65
Young patientsSevofluranePatients between 19 and 40 years-old
Primary Outcome Measures
NameTimeMethod
Hypotension incidence related to sevofluraneDuring the first 10 minutes after end tidal sevoflurane concentration stabilizes

Any mean arterial pressure drop \> 10% compared to baseline

Secondary Outcome Measures
NameTimeMethod
Systolic hypotensionDuring the first 10 minutes after end tidal sevoflurane concentration stabilizes

Systolic arterial pressure drop \>10%

Diastolic hypotensionDuring the first 10 minutes after end tidal sevoflurane concentration stabilizes

Systolic arterial pressure drop \>10%

Trial Locations

Locations (1)

Hospital Universitário de Brasilia

🇧🇷

Brasilia, Distrito Federal, Brazil

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