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

NCT03233815 | Unknown

• 1 other identifier: R-2017-3604-95
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Surgical Procedure

Keywords

Inhaled anesthesia; Total intravenous anesthesia

Outcome Measures

Primary Outcomes (1)

• IL-6

  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 Outcomes (2)

• TNFα

  The difference between TNFα at the begging of surgery and 20 minutes after the end of the cardiopulmonary bypass

• Cortisol

  The difference between cortisol at the begging of surgery and 20 minutes after the end of the cardiopulmonary bypass

Study Arms (2)

Inhaled anesthesia (Sevoflurane)

Patients undergoing cardiovascular surgery with inhaled anesthesia with sevoflurane.

Drug: Sevoflurane

Total Intravenous Anesthesia (Propofol)

Patients undergoing cardiovascular surgery with total intravenous anesthesia with propofol.

Drug: Propofol

Interventions

Propofol DRUG

Propofol anesthesia Dose: 4-6mg/kg/h

Also known as: Diprivan

Total Intravenous Anesthesia (Propofol)

Sevoflurane DRUG

Inhaled anesthesia with sevoflurane. Dose: 1-2.5 Minimum Alveolar Concentration(MAC)

Also known as: Sevorane

Inhaled anesthesia (Sevoflurane)

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for cardiovascular surgery

You may qualify if:

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

You may not qualify if:

• Diabetic patients Known allergy to propofol

Sponsors & Collaborators

• Coordinación de Investigación en Salud, Mexico: lead

Study Sites (1)

Hospital de cardiología

Mexico City, Mexico City, 06720, Mexico

Location

MeSH Terms

Interventions

Propofol; Sevoflurane

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Officials

• Ana Gallardo, PhD

  Instituto Mexicano del Seguroa Social

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2017
• First Posted: July 31, 2017
• Study Start: November 13, 2017
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: August 6, 2020

Record last verified: 2020-08

Locations

ME (1)