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

August 5, 2020 updated by: Coordinación de Investigación en Salud, Mexico

Comparison of Extubation Time Between Total Intravenous Anesthesia Guided by Bispectral Index With Spinal Anesthesia With Minimal Opioid Dose for Cardiac Surgery

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Cdmx
      • Ciudad de mexico, Cdmx, Mexico, 06720
        • Hospital de cardiología

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients scheduled for cardiac surgery

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Extubation time
Time Frame: Up to 1 hour after anesthesia emergence
The time from anesthesia emergence to extubation will be measured in minutes
Up to 1 hour after anesthesia emergence

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Coordinación de Investigación en Salud, Mexico

Investigators

  • Principal Investigator: Ana Gabriela Gallardo, PhD, IMSS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 13, 2017

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

November 13, 2017

First Submitted That Met QC Criteria

December 1, 2017

First Posted (Actual)

December 4, 2017

Study Record Updates

Last Update Posted (Actual)

August 6, 2020

Last Update Submitted That Met QC Criteria

August 5, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-2017-3604-40

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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