Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Considering that the cause of hemodynamic instability during OPCAB is closely related to right ventricular dysfunction with pulmonary artery hypertension, the use of inhaled iloprost (a selective pulmonary vasodilator) in patients undergoing OPCAB maybe beneficial for hemodynamic management. Previous research has showed that inhaled iloprost reduce pulmonary arterial pressure and pulmonary vascular resistance. Therefore, by administering inhaled iloprost before the graft anastomosis might improve cardiac output, mixed venous blood oxygen saturation, and pulmonary oxygenation during the surgery especially during the graft anastomosis.
The objective of our study is to evaluate the effect of inhaled Iloprost on hemodynamic stability in patients undergoing off-pump coronary artery bypass graft surgery.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator | Participants in this group are administered inhaled normal saline. |
|
| iloprost group | Experimental | Participants in this group are administered inhaled iloprost. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iloprost | Drug | Participants in "Iloprost group" will be administered aerosolized 20 μg iloprost in 15 min through a nebulizer connected to the inspiratory limb of the respiratory system when the internal mammary artery harvesting is done. |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative cardiac index | Compare the lowest intraoperative cardiac index between the Iloprost group and the control group during surgery, especially during the graft anastomosis. | 5 minutes before iloprost administration |
| Intraoperative cardiac index | Compare the lowest intraoperative cardiac index between the Iloprost group and the control group during surgery, especially during the graft anastomosis. | 30 minutes after Iloprost administration |
| Intraoperative cardiac index | Compare the lowest intraoperative cardiac index between the Iloprost group and the control group during surgery, especially during the graft anastomosis. | 5 minutes after the start of graft anastomosis |
| Intraoperative cardiac index | Compare the lowest intraoperative cardiac index between the Iloprost group and the control group during surgery, especially during the graft anastomosis. | 5 minutes after pericardial closure |
| Measure | Description | Time Frame |
|---|---|---|
| systemic arterial blood pressure for the intraoperative hemodynamic parameters | 15 minutes after induction of anesthesia (baseline), 5 minutes before iloprost administration, 30 minutes after Iloprost administration, 5 minutes after the start of graft anastomosis, 5 minutes after pericardial closure | |
| central venous pressure(CVP in mmhg) for the intraoperative hemodynamic parameters |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jae Kwang Shim | Contact | 82-2-2228-8516 | ANESHIM@yuhs.ac |
| Name | Affiliation | Role |
|---|---|---|
| Jae Kwang Shim | Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei Severance Hospital | Recruiting | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38148468 | Derived | Ko SH, Shim JK, Song JW, Soh S, Kwak YL. Inhaled iloprost in off-pump coronary artery bypass surgery: a randomized controlled trial. Can J Anaesth. 2024 Apr;71(4):479-489. doi: 10.1007/s12630-023-02672-3. Epub 2023 Dec 26. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Patients are divided into 2 groups, who are administered aerosolized iloprost through a nebulizer connected to the inspiratory limb of the respiratory system, or who are administered same volume of normal saline at the same time and in the same manner.
Not provided
Not provided
Neither participants, all care providers, investigators nor outcomes assessors know the treatment allocations.
| Control (Normal saline) | Drug | Participants in "Control group" will be administered aerosolized 5 ml of normal saline in 15 min through a nebulizer connected to the inspiratory limb of the respiratory system when the internal mammary artery harvesting is done. |
|
| 15 minutes after induction of anesthesia (baseline), 5 minutes before iloprost administration, 30 minutes after Iloprost administration, 5 minutes after the start of graft anastomosis, 5 minutes after pericardial closure |
| pulmonary artery pressure for the intraoperative hemodynamic parameters | 15 minutes after induction of anesthesia (baseline), 5 minutes before iloprost administration, 30 minutes after Iloprost administration, 5 minutes after the start of graft anastomosis, 5 minutes after pericardial closure |
| heart rate for the intraoperative hemodynamic parameters | 15 minutes after induction of anesthesia (baseline), 5 minutes before iloprost administration, 30 minutes after Iloprost administration, 5 minutes after the start of graft anastomosis, 5 minutes after pericardial closure |
| EKG rhythm for the intraoperative hemodynamic parameters | 15 minutes after induction of anesthesia (baseline), 5 minutes before iloprost administration, 30 minutes after Iloprost administration, 5 minutes after the start of graft anastomosis, 5 minutes after pericardial closure |
| mixed venous oxygen saturation for the intraoperative hemodynamic parameters | 15 minutes after induction of anesthesia (baseline), 5 minutes before iloprost administration, 30 minutes after Iloprost administration, 5 minutes after the start of graft anastomosis, 5 minutes after pericardial closure |
| PaO2/FiO2 ratio for the ventilation and oxygenation parameter | 15 minutes after induction of anesthesia (baseline), 5 minutes before iloprost administration, 30 minutes after Iloprost administration, 5 minutes after the start of graft anastomosis, 5 minutes after pericardial closure |
| oxygen saturation in arterial blood for the ventilation and oxygenation parameter | 15 minutes after induction of anesthesia (baseline), 5 minutes before iloprost administration, 30 minutes after Iloprost administration, 5 minutes after the start of graft anastomosis, 5 minutes after pericardial closure |
| arterial blood gas (ABG) test for oxygenation parameter | 15 minutes after induction of anesthesia (baseline), 30 minutes after Iloprost administration, 5 minutes after pericardial closure |
| airway pressure (peak, plateau, PEEP) for the lung mechanics | 15 minutes after induction of anesthesia (baseline), 5 minutes before iloprost administration, 30 minutes after Iloprost administration, 5 minutes after the start of graft anastomosis, 5 minutes after pericardial closure |
| dynamic compliance for the lung mechanics | 15 minutes after induction of anesthesia (baseline), 5 minutes before iloprost administration, 30 minutes after Iloprost administration, 5 minutes after the start of graft anastomosis, 5 minutes after pericardial closure |
| driving pressure for the lung mechanics | 15 minutes after induction of anesthesia (baseline), 5 minutes before iloprost administration, 30 minutes after Iloprost administration, 5 minutes after the start of graft anastomosis, 5 minutes after pericardial closure |
| ID | Term |
|---|---|
| D016285 | Iloprost |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided