Here is the design of a clinical trial:

Official Title: Systemic Inflammatory Response Evaluation With the Use of Inhaled Anesthetic Sevoflurane During CPB

Included conditions:
- Inflammatory Response

Study Armgroups:
- {'label': 'Sevoflurane Group', 'description': 'Group of patients receiving sevorane during extracorporeal circulation period.', 'interventionNames': ['Drug: Sevoflurane']}
- {'label': 'Not Sevoflurane Group', 'description': 'Group of patients who did not receive the sevorane during extracorporeal circulation period.'}

Interventions:
- {'type': 'DRUG', 'name': 'Sevoflurane', 'description': 'The Sevoflurane Group will receive between 0.7 and 1.5% of sevoflurane CAM only during CPB period. While Not Sevoflurane Group will receive only intravenous anesthetic agents.', 'armGroupLabels': ['Sevoflurane Group']}

Primary Outcomes:
- {'measure': 'Reduction of systemic inflammatory response', 'description': 'Cytokines are assayed in both groups at 4 different times in order to check the impact of sevoflurane on the inflammatory response. The first one is the baseline of measurement with which the others are compared and all will be compared within and between groups.', 'timeFrame': 'Through study completion, an average of 1 year'}

Please estimate the sample size based on the assumption: 
Significance level of 5%, power of 80%, and no inclusion of loss of follow-up due to intraoperative death.
Sample size
        The sample size is based on the calculations performed from the data provided by the authors of an experimental article [2] whose difference in nanograms per milliliter is greater than 50% between the means of the groups that used or not the volatile anesthetic sevoflurane during the longest CPB applied by those authors (90âmin) with a standard deviation (SD) of 30.71, a significance level of 5%, and a power of the sample of 80% generated from 100 patients causing a significant reduction in plasma PMN-elastase levels in the group that included sevoflurane in the gas circuit. Selected patients who die during the entire follow-up will be cited at the end of the trial and will remain in the study for a final analysis of the results. Therefore, the sample size calculation was consistent with the proposal to assess the inflammatory response by measuring PMN-elastase 90âmin after the onset of CPB. We use the SPSS V.19.0 software.
        The analysis of subgroups of this study will be based on the cause and effect relationship between producing a reduction in the inflammatory response after 90âmin of exposure to sevoflurane anesthetic during CPB and the intubation times, length of stay in the ICU, and length of hospital stay.
        Finally, loss of follow-up due to intraoperative death was not included, as the death rate in this period is very low for this type of procedure at the Dante Pazzanese Institute of Cardiology.