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

Brasilia University Hospital40 enrolled

Overview

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.

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

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Hypotension

Interventions

SevofluraneDRUG

Inhaled sevoflurane until allocated dose (see adaptive protocol)

Eligibility

Sex: ALLMin age: 19 YearsMax age: 120 Years

Medical Language ↔ Plain English

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;

Locations (1)

Hospital Universitário de Brasilia

Brasília, Federal District, Brazil

RECRUITING

Outcomes

Primary Outcomes

Hypotension incidence related to sevoflurane

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

Time frame: During the first 10 minutes after end tidal sevoflurane concentration stabilizes

Secondary Outcomes

Systolic hypotension

Systolic arterial pressure drop \>10%

Time frame: During the first 10 minutes after end tidal sevoflurane concentration stabilizes

Diastolic hypotension

Systolic arterial pressure drop \>10%

Time frame: During the first 10 minutes after end tidal sevoflurane concentration stabilizes

Central Contacts

Gabriel MN Guimarães, MD, MSc

CONTACT

+5561996455997 gguimaraes@unb.br

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.