Ignite Creation Date:
2024-07-17 @ 11:05 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06494969
Status:
COMPLETED
Last Update Posted:
2024-07-10
First Post:
2024-06-28
Brief Title:
Intraocular Pressure in Patients Undergoing Coronary Artery Bypass Graft Surgery With Cardiopulmonary Bypass
Sponsor:
Antalya Training and Research Hospital
Organization:
Antalya Training and Research Hospital
Study Overview
Official Title:
Effect of Sevoflurane Versus Total Intravenous Anesthesia on Intraocular Pressure in Patients Undergoing Coronary Artery Bypass Graft Surgery With Cardiopulmonary Bypass A Prospective Observational Study
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of the study to compare the effects of sevoflurane-based anesthesia and propofol-based total intravenous anesthesia on intraocular pressure IOP during coronary artery bypass graft surgery CABG with cardiopulmonary bypass CPB
The primary endpoint was to examine the effects of propofol-based total intravenous anesthesia TIVA and sevoflurane-based anesthesia methods on IOP during CABG operation Secondary endpoints included a comparison of hemodynamic variables blood gas values intensive care and hospital stay
The primary endpoint was to examine the effects of propofol-based total intravenous anesthesia TIVA and sevoflurane-based anesthesia methods on IOP during CABG operation Secondary endpoints included a comparison of hemodynamic variables blood gas values intensive care and hospital stay
Detailed Description:
Patients undergoing elective coronary artery bypass grafting surgery with cardiopulmonary bypass CPB were included in this prospective observational study Patients with a history of cardiac surgery diabetic retinopathy cataract uncontrolled hypertension chronic kidney disease glaucoma previous eye surgery previous neurological disease allergy to propofol or sevoflurane and a baseline intraocular pressure IOP greater than 30 mmHg were excluded from the study The primary endpoint was to examine the effects of propofol-based total intravenous anesthesia TIVA and sevoflurane-based anesthesia methods on IOP during CABG operation Secondary endpoints included a comparison of hemodynamic variables blood gas values intensive care and hospital stay
Intraoperative anesthesia management was standardized for both techniques and the attending anesthesiologist was asked to comply with the protocols determined within the scope of this standardization However the choice between sevoflurane-based anesthesia or propofol-based TIVA was left to the discretion of the attending cardiac anesthesiologists In the operating theatre patients were monitored with a 5-lead electrocardiography invasive arterial blood pressure via radial artery catheterization pulse oximetry and rectal temperature Initial vital signs and blood gas values were recorded No premedication was given before anesthesia induction Anesthesia induction was performed in all patients with intravenous administration of 01 mgkg midazolam 5-10 mcgkg fentanyl 05-2 mgkg propofol and 06 mgkg rocuronium An endotracheal tube with an internal diameter of 8-85 mm was used for male patients and an endotracheal tube with an internal diameter of 7-775 mm for female patients Mechanical ventilation was performed using a Drager Perseus anesthesia workstation under volume-controlled mode with fractional inspired oxygen tension Fio2 set at 05 positive end-expiratory pressure PEEP at 4-5 cmH2O tidal volume at 6-8 mlkg of predicted body weight and respiratory rate adjusted to maintain end-tidal carbon dioxide EtCO2 between 35-45 mmHg A central venous catheter was inserted into all patients using the right internal jugular vein after induction and a Foley catheter was inserted for urine monitoring Depth of anesthesia was monitored in all patients using Patient State Index PSI values Masimo Masimo Corporation Irvine CA USA and PSI values were maintained between 25-50 throughout the surgery in all patients Rocuronium was administered as 01-02 mgkg IV intermittent bolus doses for muscle relaxation
According to the choice of anesthesia type the patients were divided into two groups those using propofol-based total intravenous anesthesia TIVA Group P and those using sevoflurane-based anesthesia Group S In Group P anesthesia was maintained with an infusion of 3-10 mgkgh IV propofol In Group S anesthesia maintenance was provided with 1-15 minimum alveolar concentration MAC sevoflurane In both groups fentanyl was administered if the increase in mean arterial pressure MAP was greater than 20 from the baseline but not less than 65 mmHg During CPB in Group S sevoflurane was delivered to the oxygenator circuit via a calibrated vaporizer Blease Blease Medical Equipment Ltd Chesham UK and the MAC value was measured at the oxygenator output of the CPB circuit Extracorporeal circulation was provided with a CPB device Stockert Sorin Group Munchen Germany and an oxygenator Sechrist Sechrist Int Anaheim CA USA Before CPB 300-400 Ukg heparin was administered to achieve an Activated Coagulation Time ACT of 480 s During CPB non-pulsatile flow with a target flow rate of 22-25 lminm2 was applied and body temperature was maintained between 32-34C Hematocrit values were maintained between at least 20-25 and mean arterial pressure at 50-80 mmHg Myocardial protection was maintained with intermittent antegrade and sometimes retrograde blood cardioplegia Before weaning from CPB patients were warmed to 36-37C and heparin was neutralized with 1 mg IV protamine sulfate per 100 U All patients were transferred to the cardiovascular surgery intensive care unit ICU without extubation after the operation
Intraocular pressures were measured at eight predefined time points using the ICARE Tonometer Icare Finland Oy Vantaa Finland by a single ophthalmologist blinded to group allocation Table 1 Three consecutive measurements were taken from each eye at each time point and the average value of IOP for each eye was recorded
Arterial blood gas values pH PO2 PCO2 lactate and hematocrit were recorded at three different time points Before induction during CPB after cross-clamping and at the end of the surgery In addition hemodynamic variables systolic diastolic and mean arterial pressures heart rate and SpO2 values were recorded at the same time points as IOP measurements The length of hospital stay and ICU stay of the patients were also recorded
I n conclusion intraocular pressures were similar for both groups at all time points A statistically significant decrease was found in intraocular pressures in all measurements after induction compared to pre-induction values in both Group P and Group S p 005 Compared to IOP measured at 10 minutes after induction no statistically significant difference was found at all subsequent time points in both groups When the right and left intraocular pressures were compared no statistically significant difference was detected at all time points in both Group P and Group S
Intraoperative anesthesia management was standardized for both techniques and the attending anesthesiologist was asked to comply with the protocols determined within the scope of this standardization However the choice between sevoflurane-based anesthesia or propofol-based TIVA was left to the discretion of the attending cardiac anesthesiologists In the operating theatre patients were monitored with a 5-lead electrocardiography invasive arterial blood pressure via radial artery catheterization pulse oximetry and rectal temperature Initial vital signs and blood gas values were recorded No premedication was given before anesthesia induction Anesthesia induction was performed in all patients with intravenous administration of 01 mgkg midazolam 5-10 mcgkg fentanyl 05-2 mgkg propofol and 06 mgkg rocuronium An endotracheal tube with an internal diameter of 8-85 mm was used for male patients and an endotracheal tube with an internal diameter of 7-775 mm for female patients Mechanical ventilation was performed using a Drager Perseus anesthesia workstation under volume-controlled mode with fractional inspired oxygen tension Fio2 set at 05 positive end-expiratory pressure PEEP at 4-5 cmH2O tidal volume at 6-8 mlkg of predicted body weight and respiratory rate adjusted to maintain end-tidal carbon dioxide EtCO2 between 35-45 mmHg A central venous catheter was inserted into all patients using the right internal jugular vein after induction and a Foley catheter was inserted for urine monitoring Depth of anesthesia was monitored in all patients using Patient State Index PSI values Masimo Masimo Corporation Irvine CA USA and PSI values were maintained between 25-50 throughout the surgery in all patients Rocuronium was administered as 01-02 mgkg IV intermittent bolus doses for muscle relaxation
According to the choice of anesthesia type the patients were divided into two groups those using propofol-based total intravenous anesthesia TIVA Group P and those using sevoflurane-based anesthesia Group S In Group P anesthesia was maintained with an infusion of 3-10 mgkgh IV propofol In Group S anesthesia maintenance was provided with 1-15 minimum alveolar concentration MAC sevoflurane In both groups fentanyl was administered if the increase in mean arterial pressure MAP was greater than 20 from the baseline but not less than 65 mmHg During CPB in Group S sevoflurane was delivered to the oxygenator circuit via a calibrated vaporizer Blease Blease Medical Equipment Ltd Chesham UK and the MAC value was measured at the oxygenator output of the CPB circuit Extracorporeal circulation was provided with a CPB device Stockert Sorin Group Munchen Germany and an oxygenator Sechrist Sechrist Int Anaheim CA USA Before CPB 300-400 Ukg heparin was administered to achieve an Activated Coagulation Time ACT of 480 s During CPB non-pulsatile flow with a target flow rate of 22-25 lminm2 was applied and body temperature was maintained between 32-34C Hematocrit values were maintained between at least 20-25 and mean arterial pressure at 50-80 mmHg Myocardial protection was maintained with intermittent antegrade and sometimes retrograde blood cardioplegia Before weaning from CPB patients were warmed to 36-37C and heparin was neutralized with 1 mg IV protamine sulfate per 100 U All patients were transferred to the cardiovascular surgery intensive care unit ICU without extubation after the operation
Intraocular pressures were measured at eight predefined time points using the ICARE Tonometer Icare Finland Oy Vantaa Finland by a single ophthalmologist blinded to group allocation Table 1 Three consecutive measurements were taken from each eye at each time point and the average value of IOP for each eye was recorded
Arterial blood gas values pH PO2 PCO2 lactate and hematocrit were recorded at three different time points Before induction during CPB after cross-clamping and at the end of the surgery In addition hemodynamic variables systolic diastolic and mean arterial pressures heart rate and SpO2 values were recorded at the same time points as IOP measurements The length of hospital stay and ICU stay of the patients were also recorded
I n conclusion intraocular pressures were similar for both groups at all time points A statistically significant decrease was found in intraocular pressures in all measurements after induction compared to pre-induction values in both Group P and Group S p 005 Compared to IOP measured at 10 minutes after induction no statistically significant difference was found at all subsequent time points in both groups When the right and left intraocular pressures were compared no statistically significant difference was detected at all time points in both Group P and Group S
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None