Desflurane,Brain Natriuretic Peptide and Cardiac Surgery
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Desflurane Continuous In Group 1 of 60 patients, desflurane inhalational agent was administered continuously during coronary artery bypass graft surgery with cardiopulmonary bypass. Anesthesia induction was administered to all patients with intravenous midazolam at a dose of 0.2 mg/kg, fentanyl at a dose of 5 to 10 µg/kg and rocuronium bromide at a dose of 0.1 mg. For maintenance, in Group 1 patients, desflurane inhalational agent was administered at an end-tidal concentration of 1 to 4% during the whole surgical procedure and intravenous maintenance midazolam at a dose of 0.03 mg/kg and fentanyl at a dose of 1 to 2 µg/kg every half an hour. In Group 1 of patients, during the whole surgical procedure, attention to keep mean arterial pressure above 50 mmHg was provided. |
Drug: Desflurane Inhalational agent
Desflurane inhalational agent administration during the whole cardiac surgical operation with cardiopulmonary bypass versus administration of desflurane inhalational agent before and after cardiopulmonary bypass during the whole period of cardiac surgical operation.
Other Names:
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| Active Comparator: Desflurane Intermittent In Group 2 of 60 patients, desflurane inhalational agent was administered intermittently during coronary artery bypass graft surgery with cardiopulmonary bypass. Anesthesia induction was administered to all patients with intravenous midazolam at a dose of 0.2 mg/kg, fentanyl at a dose of 5 to 10 µg/kg and rocuronium bromide at a dose of 0.1 mg/kg. For maintenance, in Group 2 patients, desflurane inhalational agent was administered at an end-tidal concentration of 1 to 4% before and after the cardiopulmonary bypass procedure as intermittently with the addition of intravenous maintenance midazolam at a dose of 0.03 mg/kg and fentanyl at a dose of 1 to 2 µg/kg every half an hour. In Group 2 of patients, during the whole surgical procedure, attention to keep mean arterial pressure above 50 mmHg was provided. |
Drug: Desflurane Inhalational agent
Desflurane inhalational agent administration during the whole cardiac surgical operation with cardiopulmonary bypass versus administration of desflurane inhalational agent before and after cardiopulmonary bypass during the whole period of cardiac surgical operation.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Serum BNP values before the cardiac surgery [One day before cardiac surgery.]
Serum BNP values were collected from a blood sample of each patient one day before cardiac surgery
- Serum BNP values after the cardiac surgery at 24 hours [After operation at 24 hours after cardiac surgery.]
Serum BNP values were collected from a blood sample of each patient after cardiac surgery
- Serum BNP values after the cardiac surgery at 48 hours [After operation at 48 hours after cardiac surgery.]
Serum BNP values were collected from a blood sample of each patient after cardiac surgery
- Serum BNP values after the cardiac surgery at 72 hours [After operation at 72 hours after cardiac surgery.]
Serum BNP values were collected from a blood sample of each patient after cardiac surgery
- Serum BNP values before and after the cardiac surgery [After collection of the data and during statistical analysis]
The collected serum BNP values were compared with each other by repeated measure analysis
Secondary Outcome Measures
- Outcome aortic cross-clamp time [During operative time period of cardiac surgery]
A relation between serum BNP values and aortic cross-clamp time
- Outcome cardiopulmonary bypass time [During operative time period of cardiac surgery]
A relation between serum BNP values and cardiopulmonary bypass time
- Outcome use of inotropic support [During operative time period of cardiac surgery and during intensive care unit stay]
A relation between serum BNP values and use of inotropic support
- Outcome use of Intra-aortic balloon pump [During operative time period of cardiac surgery and during intensive care unit stay]
A relation between serum BNP values and use of Intra-aortic balloon pump
- Outcome duration of mechanical ventilation (>48 hours) [After operative time period of cardiac surgery and during intensive care unit stay]
A relation between serum BNP values and duration of mechanical ventilation (>48 hours)
- Outcome development of pneumonia [After operative time period of cardiac surgery and during intensive care unit stay]
A relation between serum BNP values and development of pneumonia
- Outcome parameters [During operative time period of cardiac surgery and during intensive care unit stay]
A relation between serum BNP values and perioperative myocardial infarction
- Outcome cerebrovascular event or seizure [After operative time period of cardiac surgery and during intensive care unit stay]
A relation between serum BNP values and cerebrovascular event (stroke or transient ischemic attack) or seizure
- Outcome atrial rhythm disturbances [After operative time period of cardiac surgery and during intensive care unit stay]
A relation between serum BNP values and atrial fibrillation and other atrial rhythm disturbances
- Outcome ventricular rhythm disturbances [After operative time period of cardiac surgery and during intensive care unit stay]
A relation between serum BNP values and ventricular rhythm disturbances
- Outcome renal replacement therapy [After operative time period of cardiac surgery and during intensive care unit stay]
A relation between serum BNP values and need for renal replacement therapy (RRT)
- Outcome reoperation [After operative time period of cardiac surgery and during intensive care unit stay]
A relation between serum BNP values and reoperation secondary to bleeding
- Outcome intensive care unit stay [After operative time period of cardiac surgery and during intensive care unit stay]
A relation between serum BNP values and intensive care unit stay (>3 days)
- Outcome hospital stay [After operative time period of cardiac surgery and during intensive care unit stay]
A relation between serum BNP values and intensive care unit stay (>3 days)
- Outcome thirty-day mortality [After operative time period of cardiac surgery and during intensive care unit stay]
A relation between serum BNP values and thirty-day mortality
Eligibility Criteria
Criteria
Inclusion Criteria:
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Eighteen to seventy-five years of age,
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Body mass index values between twenty-five and thirty-one,
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Ejection fraction greater than or equal to 50%.
Exclusion Criteria:
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Repeat cardiac surgery,
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Emergent surgery,
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Preoperative coagulation disorder,
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Preoperative congestive heart failure,
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Ejection fraction less than 49%,
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Preoperative renal dysfunction (serum creatinine value of greater than 1.3 mg/dL),
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Dialysis,
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Preoperative hepatic dysfunction (serum aspartate/alanine amino transferase values of greater than 40 U/L),
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Preoperative electrolyte imbalance,
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History of pancreatitis,
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Current corticosteroid treatment.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
- Trakya University Faculty of Medicine Hospital
Investigators
- Study Director: Gonul Sagiroglu, MD, Trakya University, Faculty of Medicine, Edirne, Turkey
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2013.3/13