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

Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03595319
• Other study ID #: TccFeliciaVictor2018
• Status: Recruiting
• Phase: Phase 4
• Start date: July 23, 2018
• Est. completion date: February 15, 2019

Study information

• Verified date: October 2018
• Source: Brasilia University Hospital
• Contact: Gabriel MN Guimarães, MD, MSc
• Phone: +5561996455997
• Email: gguimaraes[@]unb.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 15, 2019
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 120 Years

Eligibility

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;

Related Conditions & MeSH terms

• Hypotension

Intervention

Drug:
• Sevoflurane
Inhaled sevoflurane until allocated dose (see adaptive protocol)

Locations

Country	Name	City	State
Brazil	Hospital Universitário de Brasilia	Brasilia	Distrito Federal

Sponsors (1)

Lead Sponsor	Collaborator
Brasilia University Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypotension incidence related to sevoflurane	Any mean arterial pressure drop > 10% compared to baseline	During the first 10 minutes after end tidal sevoflurane concentration stabilizes
Secondary	Systolic hypotension	Systolic arterial pressure drop >10%	During the first 10 minutes after end tidal sevoflurane concentration stabilizes
Secondary	Diastolic hypotension	Systolic arterial pressure drop >10%	During the first 10 minutes after end tidal sevoflurane concentration stabilizes