Cardiac Surgery Clinical Trial
Official title:
An Investigation of the Association Between Desflurane Inhalational Agent, Serum Brain Natriuretic Peptide (BNP) Levels and Clinical Outcomes During Coronary Artery Bypass Graft (CABG) Surgery
During coronary artery bypass grafting (CABG) operations with cardiopulmonary bypass (CPB), the use of desflurane continuously or intermittently may have effects on serum brain natriuretic peptide (BNP) levels. The aim is to investigate the association between desflurane, serum BNP values, and clinical outcomes during CABG operations. In a prospective, randomized, double-blinded study, desflurane inhalational anesthesia was administered either continuously or intermittently (Group 1; n=60 versus Group 2; n=62). The preoperative and postoperative BNP levels at 24, 48 and 72 hours after surgery were collected. Outcomes were recorded.
Background: During coronary artery bypass grafting (CABG) operations with cardiopulmonary
bypass (CPB), the use of desflurane continuously or intermittently may have effects on serum
brain natriuretic peptide (BNP) levels.
Aim of the study: The aim is to investigate the association between desflurane, serum BNP
values, and clinical outcomes during CABG operations.
Material and methods: In a prospective, randomized, double-blinded study, desflurane
inhalational anesthesia was administered either continuously or intermittently (Group 1; n=60
versus Group 2; n=62). The preoperative and postoperative BNP levels at 24, 48 and 72 hours
after surgery were collected. Outcomes were recorded. Randomization into two groups was
performed using sealed envelopes. The sequentially numbered assignments of participants were
concealed in these envelopes during the study. The patients enrolled in the study receive an
allocation to a group after anesthesia induction by health care personnel after the opening
of the envelope. The observers were blinded to the anesthetic protocol. Caregivers were not
blinded, but they did not participate in data collection or data interpretation. Therefore,
the study protocol is considered double-blinded, masked to observers. Inclusion criteria
include; 18 to 75 years of age, body mass index of 25 to 31, ejection fraction≥50%. Exclusion
criteria include; repeat cardiac surgery, emergent surgery, preoperative coagulation
disorder, preoperative congestive heart failure, ejection fraction <49%, preoperative renal
dysfunction (serum creatinine>1.3 mg/dL), dialysis, preoperative hepatic dysfunction (serum
aspartate/alanine amino transferase>40 U/L), preoperative electrolyte imbalance, history of
pancreatitis or current corticosteroid treatment.The primary endpoint was to determine
preoperative and postoperative BNP values 24, 48 and 72 hours after surgery. The secondary
endpoint was the relation between BNP values and clinical outcomes such as; 1-Aortic
cross-clamp time, 2-Cardiopulmonary bypass time, 3-The use of inotropic support,
4-Intra-aortic balloon pump, 5-Duration of mechanical ventilation (>48 hours), 6-Development
of pneumonia, 7-Perioperative myocardial infarction, 8-Cerebrovascular event (stroke or
transient ischemic attack), seizure, 9-Atrial fibrillation and other rhythm disturbances,
10-Need for renal replacement therapy (RRT), 11-Reoperation secondary to bleeding,
12-Intensive care unit stay (>3 days), 13-Hospital stay and, 14-Thirty-day mortality.
Statistical analysis. The sample size was calculated according to the comparison of serum BNP
values in a previous study and a sample size of 58 patients per group would be required with
80% power and the conventional 2-sided type 1 error of 5%. A multiple logistic regression
analysis was performed to assess the predictive factors for weaning failure from mechanical
ventilation, and the significance level was set at a p-value of less than 0.10 in the
univariate model. To determine the best cut-off for preoperative BNP value to predict the
development of prolonged mechanical ventilation, we calculated the area under the receiver
operating characteristic curve.
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