We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03233815
Recruitment Status : Recruiting
First Posted : July 31, 2017
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Cardiovascular Surgical Procedure Drug: Propofol Drug: Sevoflurane

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 Design

Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Benefits of Total Intravenous Anesthesia Compared With Inhaled Anesthesia in Cardiovascular Surgery
Actual Study Start Date : November 13, 2017
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Groups and Cohorts

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 Name: 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 Name: Diprivan


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients scheduled for cardiovascular surgery
Criteria

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

Contacts and Locations

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): NCT03233815


Contacts
Contact: Ana Gallardo, PhD 5556276900 ext 22154 anagabygh@gmail.com

Locations
Mexico
Hospital de cardiología Recruiting
Ciudad de mexico, Cdmx, Mexico, 06720
Contact: Ana Gabriela Gall, PhD         
Sponsors and Collaborators
Coordinación de Investigación en Salud, Mexico
Investigators
Principal Investigator: Ana Gallardo, PhD Instituto Mexicano del Seguroa Social
More Information

Responsible Party: Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier: NCT03233815     History of Changes
Other Study ID Numbers: R-2017-3604-95
First Posted: July 31, 2017    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The plan is not decided yet.

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:
Inhaled anesthesia
Total intravenous anesthesia

Additional relevant MeSH terms:
Anesthetics
Propofol
Sevoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Platelet Aggregation Inhibitors
Anesthetics, Inhalation