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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02864212
Other study ID # R-2014-785-063
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date September 2014
Est. completion date December 2021

Study information

Verified date July 2020
Source Coordinación de Investigación en Salud, Mexico
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this observational study is to create a data base to extract feature of fast-acting drugs that can be monitor in real time to design control strategies based on high order sliding mode controller to create a robust drug infusion system.


Description:

The aim of this observational study is to create a database to extract feature of fast-acting drugs that can be monitor in real time to design control strategies based on high order sliding mode controller to create a robust drug infusion system.

The observed drugs in this study are fast acting insulin, propofol and sodium nitroprusside.

The effect of insulin will be measured by a continuous glucose monitor, the effect of propofol by a bispectral index monitor and the the effect of sodium nitroprusside by a invasive blood pressure monitor.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 30
Est. completion date December 2021
Est. primary completion date December 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- American Society of Anesthesiologists (ASA) physical status I, II, II

Exclusion Criteria:

- Impossibility to measure depth of anesthesia or invasive blood pressure. Impossibility of using glucose monitor.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Mexico Unidad de Investigación Médica en Enfermedades Metabólicas IMSS Mexico Mexico City

Sponsors (1)

Lead Sponsor Collaborator
Coordinación de Investigación en Salud, Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Glucose The glucose will be measured by a continuous glucose monitor. For the group of patients for diabetes.
Note: This protocol has three primary outputs because its objective is to create a database of each output to analyze the response to the associated drug (insulin, propofol and sodium nitroprusside.
Every 5 minutes during 3 days.
Primary Bispectral Index Depth of anesthesia will be measured by a Bispectral Index monitor. Every second during surgery
Primary Invasive blood pressure Every 5 minutes during surgery
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