MACBIS50 in Patients Undergoing CAG During Normothermic CPB Phase.

NCT02711384 | Completed DMC

• 1 other identifier: 4555
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Background: We determined the minimum alveolar concentration (MAC) of sevoflurane for maintaining bispectral index (BIS) below 50 (MACBIS50) in patients undergoing coronary artery bypass grafting during normothermic cardiopulmonary bypass phase. Method: Fifteen patients, American Society of Anestesiology physical status III or IV, aged 40-70, undergoing elective coronary artery bypass grafting, were enrolled in our study. The predetermined target end-tidal sevoflurane concentration was maintained for at least ten minutes during normothermic cardiopulmonary bypass phase. BIS values were then recorded at an interval of 10 s for 1 min. The dial settings were adjusted to attain an end-tidal sevoflurane concentration of 1% in the first patient. If a given patient had an average BIS of \< 50, the sevoflurane concentration was reduced by 0.1% in the subsequent patient, whereas if a given patient had a BIS ≥ 50, the sevoflurane concentration was increased by 0.1% in the next patient. MACBIS50 was calculated using the midpoint concentration of patients involving a crossover according to the up-down method. Average of the crossover midpoints in each pair defined effective dose 50. Data were also analyzed by a logistic regression test to obtain the probability of BIS \< 50 versus end-tidal sevoflurane concentration. Result: MACBIS50 of sevoflurane was 0,82% (95% confidence intervals: 0,47-1,16) in patients undergoing coronary artery bypass grafting during normothermic cardiopulmonary bypass phase. Conclusion: MACBIS50 determined in this study was 15% lower compared to MACBIS50 in middle-aged adults after tracheal intubation.

Conditions

Coronary Disease; Coronary Artery Disease

Keywords

Sevoflurane; Coronary artery bypass grafting; Cardiopulmonary bypass; Inhalation anesthesia; MACBIS50

Outcome Measures

Primary Outcomes (1)

• MACBIS50 in patients undergoing CAG during normothermic CPB phase.

  To determine the minimum alveolar concentration of sevoflurane for maintaining bispectral index below 50 in patients undergoing coronary artery bypass grafting during normothermic cardiopulmonary bypass phase.

  1 year

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

American Society of Anestesiology physical status III or IV, aged 40-70, undergoing elective coronary artery bypass grafting

You may qualify if:

• American Society of Anestesiology physical status III or IV;
• Aged 40-70;
• Undergoing elective coronary artery bypass grafting.

You may not qualify if:

• History of psychiatric or neurological diseases;
• Drug abuse or medications that affect the central nervous system;
• Pregnancy;
• Combined surgeries;
• Reoperation in cardiac surgery;
• Emergency procedures;
• Neuraxial blockade.

Sponsors & Collaborators

• Instituto Dante Pazzanese de Cardiologia: lead

Study Sites (1)

Instituto Dante Pazzanese de Cardiologia

São Paulo, São Paulo, 04012-909, Brazil

Location

MeSH Terms

Conditions

Coronary Disease; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 8, 2016
• First Posted: March 17, 2016
• Study Start: March 25, 2018
• Primary Completion: February 25, 2020
• Study Completion: February 28, 2020
• Last Updated: March 3, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)