Benefits of Total Intravenous Anesthesia Compared With Inhaled Anesthesia in Cardiovascular Surgery

August 5, 2020 updated by: Coordinación de Investigación en Salud, Mexico
This study compares the difference in proinflammatory markers Interleukin 6 (IL-6), Tumor necrosis factor alpha (TNFα) and cortisol in patients undergoing cardiovascular surgery to asses if there is a benefit of using intravenous total anesthesia (TIVA) over inhaled anesthesia for this procedures.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

IL-6, TNFα and cortisol will be measure at the beginning of the cardiovascular surgery and 20 minutes after the cardiovascular bypass ends to calculate the difference between them and compare if there is any statistical difference between the proinflammatory markers with the two anesthesia techniques.

Study Type

Observational

Enrollment (Anticipated)

40

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

20 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients scheduled for cardiovascular surgery

Description

Inclusion Criteria:

Scheduled for cardiovascular surgery American Society of Anaesthesiologists (ASA) physical status classification II-IV BMI < 25 HbA1c < 7%

Exclusion Criteria:

Diabetic patients Known allergy to propofol

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
Inhaled anesthesia (Sevoflurane)
Patients undergoing cardiovascular surgery with inhaled anesthesia with sevoflurane.
Drug: Sevoflurane
Inhaled anesthesia with sevoflurane. Dose: 1-2.5 Minimum Alveolar Concentration(MAC)
Other Names:
  • Sevorane
Total Intravenous Anesthesia (Propofol)
Patients undergoing cardiovascular surgery with total intravenous anesthesia with propofol.
Drug: Propofol
Propofol anesthesia Dose: 4-6mg/kg/h
Other Names:
  • Diprivan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IL-6
Time Frame: The difference between IL-6 at the begging of surgery and 20 minutes after the end of the cardiopulmonary bypass
IL-6 will be compared between the groups.
The difference between IL-6 at the begging of surgery and 20 minutes after the end of the cardiopulmonary bypass

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TNFα
Time Frame: The difference between TNFα at the begging of surgery and 20 minutes after the end of the cardiopulmonary bypass
TNFα will be compared between the groups
The difference between TNFα at the begging of surgery and 20 minutes after the end of the cardiopulmonary bypass
Cortisol
Time Frame: The difference between cortisol at the begging of surgery and 20 minutes after the end of the cardiopulmonary bypass
Cortisol will be compared between the groups
The difference between cortisol at the begging of surgery and 20 minutes after the end of the cardiopulmonary bypass

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 Gallardo, PhD, Instituto Mexicano del Seguroa Social

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

July 26, 2017

First Submitted That Met QC Criteria

July 26, 2017

First Posted (Actual)

July 31, 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-2017-3604-95

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The plan is not decided yet.

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.

Clinical Trials on Cardiovascular Surgical Procedure

Clinical Trials on Sevoflurane

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Kingdom

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe