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

NCT03595319 | Unknown Phase 4

• 1 other identifier: TccFeliciaVictor2018
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypotension

Keywords

Hypotension; Sevoflurane; Elderly

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Systolic hypotension

  During the first 10 minutes after end tidal sevoflurane concentration stabilizes

• Diastolic hypotension

  During the first 10 minutes after end tidal sevoflurane concentration stabilizes

Study Arms (2)

Young patients

EXPERIMENTAL

Patients between 19 and 40 years-old

Drug: Sevoflurane

Elder patients

EXPERIMENTAL

Older than 65

Drug: Sevoflurane

Interventions

Sevoflurane DRUG

Inhaled sevoflurane until allocated dose (see adaptive protocol)

Elder patients; Young patients

Eligibility Criteria

• Age: 19 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Understands experiment, is voluntary, signs informed consent;
• Does not take medication that influences arterial pressure;
• Normotensive.

You may not qualify if:

• Received any medication that influences arterial pressure before experiment;

Sponsors & Collaborators

• Brasilia University Hospital: lead

Study Sites (1)

Hospital Universitário de Brasilia

Brasília, Federal District, 70000000, Brazil

RECRUITING

MeSH Terms

Conditions

Hypotension

Interventions

Sevoflurane

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Officials

• Gabriel MN Guimarães, MD, MSc

  University of Brasilia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriel MN Guimarães, MD, MSc

CONTACT

+5561996455997; gguimaraes@unb.br

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant will not know allocation (sevoflurane concentration) and will be under general anesthesia
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Anesthesiology

Model Details: 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.

Study Record Dates

• First Submitted: July 12, 2018
• First Posted: July 23, 2018
• Study Start: July 23, 2018
• Primary Completion: October 1, 2018
• Study Completion: February 15, 2019
• Last Updated: October 30, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Up until mendeley data can host
• Access Criteria: Open access

Locations

BR (1)