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Completed

NCT Number: NCT04238806

Desflurane,Brain Natriuretic Peptide and Cardiac Surgery

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Suprane

Primary outcomes

  1. Serum BNP values before the cardiac surgery

    Time frame: One day before cardiac surgery.

    Serum BNP values were collected from a blood sample of each patient one day before cardiac surgery

  2. Serum BNP values after the cardiac surgery at 24 hours

    Time frame: After operation at 24 hours after cardiac surgery.

    Serum BNP values were collected from a blood sample of each patient after cardiac surgery

  3. Serum BNP values after the cardiac surgery at 48 hours

    Time frame: After operation at 48 hours after cardiac surgery.

    Serum BNP values were collected from a blood sample of each patient after cardiac surgery

  4. Serum BNP values after the cardiac surgery at 72 hours

    Time frame: After operation at 72 hours after cardiac surgery.

    Serum BNP values were collected from a blood sample of each patient after cardiac surgery

  5. Serum BNP values before and after the cardiac surgery

    Time frame: After collection of the data and during statistical analysis

    The collected serum BNP values were compared with each other by repeated measure analysis

Secondary outcomes

  1. Outcome aortic cross-clamp time

    Time frame: During operative time period of cardiac surgery

    A relation between serum BNP values and aortic cross-clamp time

  2. Outcome cardiopulmonary bypass time

    Time frame: During operative time period of cardiac surgery

    A relation between serum BNP values and cardiopulmonary bypass time

  3. Outcome use of inotropic support

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

    A relation between serum BNP values and use of inotropic support

  4. Outcome use of Intra-aortic balloon pump

    Time frame: 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

  5. Outcome duration of mechanical ventilation (>48 hours)

    Time frame: 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)

  6. Outcome development of pneumonia

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

    A relation between serum BNP values and development of pneumonia

  7. Outcome parameters

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

    A relation between serum BNP values and perioperative myocardial infarction

  8. Outcome cerebrovascular event or seizure

    Time frame: 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

  9. Outcome atrial rhythm disturbances

    Time frame: 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

  10. Outcome ventricular rhythm disturbances

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

    A relation between serum BNP values and ventricular rhythm disturbances

  11. Outcome renal replacement therapy

    Time frame: 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)

  12. Outcome reoperation

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

    A relation between serum BNP values and reoperation secondary to bleeding

  13. Outcome intensive care unit stay

    Time frame: 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)

  14. Outcome hospital stay

    Time frame: 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)

  15. Outcome thirty-day mortality

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

    A relation between serum BNP values and thirty-day mortality

Sponsors and collaborators

Lead sponsor

Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

Other Gov

Collaborators

  • Trakya University Teaching and Research Hospital

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 23, 2020
Registry last updated
Jan 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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