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Desflurane,Brain Natriuretic Peptide and Cardiac Surgery

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04238806
Enrollment
151
Registered
2020-01-23
Start date
2013-09-01
Completion date
2014-09-30
Last updated
2020-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Natriuretic Peptide, Cardiac Surgery, Cardiopulmonary Bypass, Coronary Artery Bypass Graft Surgery, Desflurane, Outcome

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.

Interventions

DRUGDesflurane 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.

Sponsors

Trakya University Faculty of Medicine Hospital
CollaboratorUNKNOWN
Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)

Masking description

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.

Intervention model description

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).

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Serum BNP values before the cardiac surgeryOne 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 hoursAfter 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 hoursAfter 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 hoursAfter 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 surgeryAfter collection of the data and during statistical analysisThe collected serum BNP values were compared with each other by repeated measure analysis

Secondary

MeasureTime frameDescription
Outcome development of pneumoniaAfter operative time period of cardiac surgery and during intensive care unit stayA relation between serum BNP values and development of pneumonia
Outcome parametersDuring operative time period of cardiac surgery and during intensive care unit stayA relation between serum BNP values and perioperative myocardial infarction
Outcome cerebrovascular event or seizureAfter operative time period of cardiac surgery and during intensive care unit stayA relation between serum BNP values and cerebrovascular event (stroke or transient ischemic attack) or seizure
Outcome atrial rhythm disturbancesAfter operative time period of cardiac surgery and during intensive care unit stayA relation between serum BNP values and atrial fibrillation and other atrial rhythm disturbances
Outcome ventricular rhythm disturbancesAfter operative time period of cardiac surgery and during intensive care unit stayA relation between serum BNP values and ventricular rhythm disturbances
Outcome aortic cross-clamp timeDuring operative time period of cardiac surgeryA relation between serum BNP values and aortic cross-clamp time
Outcome reoperationAfter operative time period of cardiac surgery and during intensive care unit stayA relation between serum BNP values and reoperation secondary to bleeding
Outcome intensive care unit stayAfter operative time period of cardiac surgery and during intensive care unit stayA relation between serum BNP values and intensive care unit stay (\>3 days)
Outcome hospital stayAfter operative time period of cardiac surgery and during intensive care unit stayA relation between serum BNP values and intensive care unit stay (\>3 days)
Outcome thirty-day mortalityAfter operative time period of cardiac surgery and during intensive care unit stayA relation between serum BNP values and thirty-day mortality
Outcome renal replacement therapyAfter operative time period of cardiac surgery and during intensive care unit stayA relation between serum BNP values and need for renal replacement therapy (RRT)
Outcome cardiopulmonary bypass timeDuring operative time period of cardiac surgeryA relation between serum BNP values and cardiopulmonary bypass time
Outcome use of inotropic supportDuring operative time period of cardiac surgery and during intensive care unit stayA relation between serum BNP values and use of inotropic support
Outcome use of Intra-aortic balloon pumpDuring operative time period of cardiac surgery and during intensive care unit stayA 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 stayA relation between serum BNP values and duration of mechanical ventilation (\>48 hours)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026