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Comparison of Extubation Time Between Total Intravenous Anesthesia With Spinal Anesthesia for Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT03360955
Recruitment Status : Recruiting
First Posted : December 4, 2017
Last Update Posted : December 4, 2017
Sponsor:
Information provided by (Responsible Party):
Coordinación de Investigación en Salud, Mexico

Brief Summary:
This study compares the extubation time between total intravenous anesthesia guided by Bispectral Index with spinal anesthesia with minimal opioid dose for cardiac surgery.

Condition or disease Intervention/treatment
Anesthesia Procedure: Anesthesia

Detailed Description:

This study compares the time needed to extubate of two anesthesic techniques, 1) Total Intravenous Anesthesia guided by Bispectral Index (BIS), 2) Spinal Anesthesia with minimal opioid dose for cardiac surgery.

Identify the best anesthesia technique to do ultrafast track extubation can minimize the risk of infection associated.


Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Comparison of Extubation Time Between Total Intravenous Anesthesia Guided by Bispectral Index With Spinal Anesthesia With Minimal Opioid Dose for Cardiac Surgery
Actual Study Start Date : November 13, 2017
Estimated Primary Completion Date : December 13, 2018
Estimated Study Completion Date : April 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Group/Cohort Intervention/treatment
Total Intravenous Anesthesia
Patients with total intravenous anesthesia during the cardiac surgery
Procedure: Anesthesia
Different anesthesia technique will be compared to find out which one offers better outcome to perform ultrafast track extubation

Spinal Anesthesia
Patients with spinal anesthesia with minimal opioid dose.
Procedure: Anesthesia
Different anesthesia technique will be compared to find out which one offers better outcome to perform ultrafast track extubation




Primary Outcome Measures :
  1. Extubation time [ Time Frame: Up to 1 hour after anesthesia emergence ]
    The time from anesthesia emergence to extubation will be measured in minutes



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients scheduled for cardiac surgery
Criteria

Inclusion Criteria:

Patients scheduled for cardiac surgery Physical Status Classification System of the American Society of Anesthesiologists (ASA) II-III

Exclusion Criteria:

Physical Status Classification System of the American Society of Anesthesiologists (ASA) IV-V Emergency cardiac surgery Spinal defect


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03360955


Contacts
Contact: Ana Gabriela Gallardo, PhD 5556276900 ext 22154 anagabygh@gmail.com
Contact: Jose Antonio Sanchez, MD 5556276900 ext 221534

Locations
Mexico
Hospital de cardiología Recruiting
Ciudad de mexico, Cdmx, Mexico, 06720
Contact: Ana Gabriela Gallardo, PhD    5556276900 ext 22154    anagabygh@gmail.com   
Contact: Jose Antonio Sanchez, MD    5556276900 ext 22154      
Sponsors and Collaborators
Coordinación de Investigación en Salud, Mexico
Investigators
Principal Investigator: Ana Gabriela Gallardo, PhD IMSS

Responsible Party: Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier: NCT03360955     History of Changes
Other Study ID Numbers: R-2017-3604-40
First Posted: December 4, 2017    Key Record Dates
Last Update Posted: December 4, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Coordinación de Investigación en Salud, Mexico:
Extubation
Cardiac Surgery

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs