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

B

Brasilia University Hospital

Status and phase

Unknown
Phase 4

Conditions

Hypotension

Treatments

Drug: Sevoflurane

Study type

Interventional

Funder types

Other

Identifiers

NCT03595319
TccFeliciaVictor2018

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

19 to 120 years old

Volunteers

No 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;

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

Single Blind

40 participants in 2 patient groups

Young patients
Experimental group
Description:
Patients between 19 and 40 years-old
Treatment:
Drug: Sevoflurane
Elder patients
Experimental group
Description:
Older than 65
Treatment:
Drug: Sevoflurane

Trial contacts and locations

1

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Central trial contact

Gabriel MN Guimarães, MD, MSc

Data sourced from clinicaltrials.gov

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