Desflurane,Brain Natriuretic Peptide and Cardiac Surgery

Not Applicable

Completed

• Conditions: Brain Natriuretic Peptide; Coronary Artery Bypass Graft Surgery; Cardiopulmonary Bypass; Cardiac Surgery; Desflurane; Outcome
• Interventions: Drug: Desflurane Inhalational agent

• Registration Number: NCT04238806
• Lead Sponsor: Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

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.

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 Timeline

• Study Start: 2013-09-01
• Primary Completion: 2014-08-31
• Study Completion: 2014-09-30
• Status Verified: 2020-01
• Study First Submitted: 2020-01-13
• Study First Submitted QC: 2020-01-20
• Last Update Submitted: 2020-01-20
• Study First Posted: 2020-01-23
• Last Update Posted: 2020-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

Inclusion Criteria

• Eighteen to seventy-five years of age,
• Body mass index values between twenty-five and thirty-one,
• Ejection fraction greater than or equal to 50%.

Exclusion Criteria

• Repeat cardiac surgery,
• Emergent surgery,
• Preoperative coagulation disorder,
• Preoperative congestive heart failure,
• Ejection fraction less than 49%,
• Preoperative renal dysfunction (serum creatinine value of greater than 1.3 mg/dL),
• Dialysis,
• Preoperative hepatic dysfunction (serum aspartate/alanine amino transferase values of greater than 40 U/L),
• Preoperative electrolyte imbalance,
• History of pancreatitis,
• Current corticosteroid treatment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Desflurane Continuous	Desflurane Inhalational agent	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.
Desflurane Intermittent	Desflurane Inhalational agent	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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 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 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
Outcome aortic cross-clamp time	During operative time period of cardiac surgery	A relation between serum BNP values and aortic cross-clamp time
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)