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

Cardiovascular Surgical Procedure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03233815
• Other study ID #: R-2017-3604-95
• Status: Active, not recruiting
• Start date: November 13, 2017
• Est. completion date: December 2021

Study information

• Verified date: August 2020
• Source: Coordinación de Investigación en Salud, Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Surgical Procedure
• Respiratory Aspiration

Intervention

Drug:
• Propofol
Propofol anesthesia Dose: 4-6mg/kg/h
• Sevoflurane
Inhaled anesthesia with sevoflurane. Dose: 1-2.5 Minimum Alveolar Concentration(MAC)

Locations

Country	Name	City	State
Mexico	Hospital de cardiología	Ciudad de mexico	Cdmx

Sponsors (1)

Lead Sponsor	Collaborator
Coordinación de Investigación en Salud, Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	TNFa	TNFa will be compared between the groups	The difference between TNFa at the begging of surgery and 20 minutes after the end of the cardiopulmonary bypass
Secondary	Cortisol	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