Desflurane,Brain Natriuretic Peptide and Cardiac Surgery

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04238806
• Other study ID #: 2013.3/13
• Status: Completed
• Phase: N/A
• Start date: September 1, 2013
• Est. completion date: September 30, 2014

Study information

• Verified date: January 2020
• Source: Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: September 30, 2014
• Est. primary completion date: August 31, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital	Trakya University Faculty of Medicine Hospital

References & Publications (11)

Cuthbertson BH, Amiri AR, Croal BL, Rajagopalan S, Alozairi O, Brittenden J, Hillis GS. Utility of B-type natriuretic peptide in predicting perioperative cardiac events in patients undergoing major non-cardiac surgery. Br J Anaesth. 2007 Aug;99(2):170-6. — View Citation

Cuthbertson BH, Croal BL, Rae D, Gibson PH, McNeilly JD, Jeffrey RR, Smith WC, Prescott GJ, Buchan KG, El-Shafei H, Gibson GA, Hillis GS. N-terminal pro-B-type natriuretic peptide levels and early outcome after cardiac surgery: a prospective cohort study. — View Citation

De Hert SG, Cromheecke S, ten Broecke PW, Mertens E, De Blier IG, Stockman BA, Rodrigus IE, Van der Linden PJ. Effects of propofol, desflurane, and sevoflurane on recovery of myocardial function after coronary surgery in elderly high-risk patients. Anesth — View Citation

Fox AA, Nascimben L, Body SC, Collard CD, Mitani AA, Liu KY, Muehlschlegel JD, Shernan SK, Marcantonio ER. Increased perioperative b-type natriuretic peptide associates with heart failure hospitalization or heart failure death after coronary artery bypass — View Citation

Hutfless R, Kazanegra R, Madani M, Bhalla MA, Tulua-Tata A, Chen A, Clopton P, James C, Chiu A, Maisel AS. Utility of B-type natriuretic peptide in predicting postoperative complications and outcomes in patients undergoing heart surgery. J Am Coll Cardiol — View Citation

Karthikeyan G, Moncur RA, Levine O, Heels-Ansdell D, Chan MT, Alonso-Coello P, Yusuf S, Sessler D, Villar JC, Berwanger O, McQueen M, Mathew A, Hill S, Gibson S, Berry C, Yeh HM, Devereaux PJ. Is a pre-operative brain natriuretic peptide or N-terminal pro — View Citation

Litton E, Ho KM. The use of pre-operative brain natriuretic peptides as a predictor of adverse outcomes after cardiac surgery: a systematic review and meta-analysis. Eur J Cardiothorac Surg. 2012 Mar;41(3):525-34. doi: 10.1093/ejcts/ezr007. Epub 2011 Oct — View Citation

Lurati Buse GA, Koller MT, Burkhart C, Seeberger MD, Filipovic M. The predictive value of preoperative natriuretic peptide concentrations in adults undergoing surgery: a systematic review and meta-analysis. Anesth Analg. 2011 May;112(5):1019-33. doi: 10.1 — View Citation

Murad Junior JA, Nakazone MA, Machado Mde N, Godoy MF. Predictors of mortality in cardiac surgery: brain natriuretic peptide type B. Rev Bras Cir Cardiovasc. 2015 Mar-Apr;30(2):182-7. doi: 10.5935/1678-9741.20150008. — View Citation

Uhlig C, Bluth T, Schwarz K, Deckert S, Heinrich L, De Hert S, Landoni G, Serpa Neto A, Schultz MJ, Pelosi P, Schmitt J, Gama de Abreu M. Effects of Volatile Anesthetics on Mortality and Postoperative Pulmonary and Other Complications in Patients Undergoi — View Citation

Yun KH, Jeong MH, Oh SK, Choi JH, Rhee SJ, Park EM, Yoo NJ, Kim NH, Ahn YK, Jeong JW. Preoperative plasma N-terminal pro-brain natriuretic peptide concentration and perioperative cardiovascular risk in elderly patients. Circ J. 2008 Feb;72(2):195-9. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum BNP values before the cardiac surgery	Serum BNP values were collected from a blood sample of each patient one day before cardiac surgery	One day before cardiac surgery.
Primary	Serum BNP values after the cardiac surgery at 24 hours	Serum BNP values were collected from a blood sample of each patient after cardiac surgery	After operation at 24 hours after cardiac surgery.
Primary	Serum BNP values after the cardiac surgery at 48 hours	Serum BNP values were collected from a blood sample of each patient after cardiac surgery	After operation at 48 hours after cardiac surgery.
Primary	Serum BNP values after the cardiac surgery at 72 hours	Serum BNP values were collected from a blood sample of each patient after cardiac surgery	After operation at 72 hours after cardiac surgery.
Primary	Serum BNP values before and after the cardiac surgery	The collected serum BNP values were compared with each other by repeated measure analysis	After collection of the data and during statistical analysis
Secondary	Outcome aortic cross-clamp time	A relation between serum BNP values and aortic cross-clamp time	During operative time period of cardiac surgery
Secondary	Outcome cardiopulmonary bypass time	A relation between serum BNP values and cardiopulmonary bypass time	During operative time period of cardiac surgery
Secondary	Outcome use of inotropic support	A relation between serum BNP values and use of inotropic support	During operative time period of cardiac surgery and during intensive care unit stay
Secondary	Outcome use of Intra-aortic balloon pump	A relation between serum BNP values and use of Intra-aortic balloon pump	During operative time period of cardiac surgery and during intensive care unit stay
Secondary	Outcome duration of mechanical ventilation (>48 hours)	A relation between serum BNP values and duration of mechanical ventilation (>48 hours)	After operative time period of cardiac surgery and during intensive care unit stay
Secondary	Outcome development of pneumonia	A relation between serum BNP values and development of pneumonia	After operative time period of cardiac surgery and during intensive care unit stay
Secondary	Outcome parameters	A relation between serum BNP values and perioperative myocardial infarction	During operative time period of cardiac surgery and during intensive care unit stay
Secondary	Outcome cerebrovascular event or seizure	A relation between serum BNP values and cerebrovascular event (stroke or transient ischemic attack) or seizure	After operative time period of cardiac surgery and during intensive care unit stay
Secondary	Outcome atrial rhythm disturbances	A relation between serum BNP values and atrial fibrillation and other atrial rhythm disturbances	After operative time period of cardiac surgery and during intensive care unit stay
Secondary	Outcome ventricular rhythm disturbances	A relation between serum BNP values and ventricular rhythm disturbances	After operative time period of cardiac surgery and during intensive care unit stay
Secondary	Outcome renal replacement therapy	A relation between serum BNP values and need for renal replacement therapy (RRT)	After operative time period of cardiac surgery and during intensive care unit stay
Secondary	Outcome reoperation	A relation between serum BNP values and reoperation secondary to bleeding	After operative time period of cardiac surgery and during intensive care unit stay
Secondary	Outcome intensive care unit stay	A relation between serum BNP values and intensive care unit stay (>3 days)	After operative time period of cardiac surgery and during intensive care unit stay
Secondary	Outcome hospital stay	A relation between serum BNP values and intensive care unit stay (>3 days)	After operative time period of cardiac surgery and during intensive care unit stay
Secondary	Outcome thirty-day mortality	A relation between serum BNP values and thirty-day mortality	After operative time period of cardiac surgery and during intensive care unit stay