Desflurane,Brain Natriuretic Peptide and Cardiac Surgery

NCT04238806 | Completed

• 1 other identifier: 2013.3/13
• Study Type: interventional
• Target: 151
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• 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.

• 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.

• 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.

• 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.

• 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 Outcomes (15)

• Outcome aortic cross-clamp time

  During operative time period of cardiac surgery

• Outcome cardiopulmonary bypass time

  During operative time period of cardiac surgery

• Outcome use of inotropic support

  During operative time period of cardiac surgery and during intensive care unit stay

• Outcome use of Intra-aortic balloon pump

  During operative time period of cardiac surgery and during intensive care unit stay

• Outcome duration of mechanical ventilation (>48 hours)

  After operative time period of cardiac surgery and during intensive care unit stay

Study Arms (2)

Desflurane Continuous

ACTIVE COMPARATOR

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 Intermittent

ACTIVE COMPARATOR

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

Interventions

Desflurane Inhalational agent DRUG

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.

Also known as: Suprane

Desflurane Continuous; Desflurane Intermittent

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital: lead
• Trakya University Teaching and Research Hospital: collaborator

Related Publications (11)

• 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. Anesthesiology. 2003 Aug;99(2):314-23. doi: 10.1097/00000542-200308000-00013.

  PMID: 12883404 RESULT

• 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. doi: 10.1093/bja/aem158. Epub 2007 Jun 15.

  PMID: 17573389 RESULT

• 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-B-type natriuretic peptide measurement an independent predictor of adverse cardiovascular outcomes within 30 days of noncardiac surgery? A systematic review and meta-analysis of observational studies. J Am Coll Cardiol. 2009 Oct 20;54(17):1599-606. doi: 10.1016/j.jacc.2009.06.028.

  PMID: 19833258 RESULT

• 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 Undergoing Surgery: A Systematic Review and Meta-analysis. Anesthesiology. 2016 Jun;124(6):1230-45. doi: 10.1097/ALN.0000000000001120.

  PMID: 27065094 RESULT

• 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. doi: 10.1253/circj.72.195.

  PMID: 18219153 RESULT

• 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 graft surgery. Anesthesiology. 2013 Aug;119(2):284-94. doi: 10.1097/ALN.0b013e318299969c.

  PMID: 23695172 RESULT

• 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 20.

  PMID: 22345176 RESULT

• 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. 2004 May 19;43(10):1873-9. doi: 10.1016/j.jacc.2003.12.048.

  PMID: 15145114 RESULT

• 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.

  PMID: 26107449 RESULT

• 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: 10.1213/ANE.0b013e31820f286f. Epub 2011 Mar 3.

  PMID: 21372274 RESULT

• 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. Br J Anaesth. 2009 Nov;103(5):647-53. doi: 10.1093/bja/aep234. Epub 2009 Aug 27.

  PMID: 19713279 RESULT

MeSH Terms

Interventions

Desflurane

Intervention Hierarchy (Ancestors)

Ethyl Ethers; Ethers; Organic Chemicals; Methyl Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons

Study Officials

• Gonul Sagiroglu, MD

  Trakya University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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).

Study Record Dates

• First Submitted: January 13, 2020
• First Posted: January 23, 2020
• Study Start: September 1, 2013
• Primary Completion: August 31, 2014
• Study Completion: September 30, 2014
• Last Updated: January 23, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: The Study Protocol, the Clinical Study Report and the Statistical Analysis Plan are available after ClinicalTrials.gov registration.
• Access Criteria: Accessible to all researchers