Intraocular PressureNCT06494969
Intraocular Pressure in Patients Undergoing Coronary Artery Bypass Graft Surgery With Cardiopulmonary Bypass
An observational study of Intraocular Pressure and Anesthesia, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraocular Pressure, Anesthesia
- What is being tested?
- Intraocular pressure measurement
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2021to 28 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing elective coronary artery bypass grafting surgery with cardiopulmonary bypass (CPB) were included.
Who may be able to join
- Patients undergoing elective coronary artery bypass grafting surgery with cardiopulmonary bypass (CPB)
Who cannot join
- history of cardiac surgery
- diabetic retinopathy
- cataract
- uncontrolled hypertension
- chronic kidney disease
- glaucoma
Show all 10Show fewer
- previous eye surgery
- previous neurological disease
- allergy to propofol or sevoflurane
- baseline intraocular pressure (IOP) greater than 30 mmHg
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Health Science University, Antalya Training and Research Hospital
Antalya, Muratpasa, 071**
About this study
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
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.
Read the 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 0.1 mg/kg midazolam, 5-10 mcg/kg fentanyl, 0.5-2 mg/kg propofol, and 0.6 mg/kg rocuronium. An endotracheal tube with an internal diameter of 8-8.5 mm was used for male patients and an endotracheal tube with an internal diameter of 7-7.75 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 0.5, positive end-expiratory pressure (PEEP) at 4-5 cmH2O, tidal volume at 6-8 ml/kg 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 0.1-0.2 mg/kg 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 mg/kg/h IV propofol. In Group S, anesthesia maintenance was provided with 1-1.5 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 U/kg heparin was administered to achieve an Activated Coagulation Time (ACT) of 480 s. During CPB, non-pulsatile flow with a target flow rate of 2.2-2.5 l/min/m2 was applied, and body temperature was maintained between 32-34°C. 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 36-37°C, 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 < 0.05). 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.
- Conditions
- Intraocular Pressure, Anesthesia
- Being tested
- Intraocular pressure measurement
- Keywords
- Intraocular pressure, cardiac surgery, coronary artery bypass grafting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraocular pressure measurementDevice
Intraocular pressures were measured and recorded at 8 predefined time points using a tonometer; before anesthesia induction (T1), 10 min after induction (T2), immediately before the beginning of CPB (T3), 3 minute after the beginning of CPB (T4), 3 minute after cross-clamping (T5), 3min after cross-clamp removal (T6), immediately before the weaning of CPB (T7), and end of the surgery (immediately after skin closure) (T8).
| Study group | Role | What they receive |
|---|---|---|
| Group P | Propofol-based total intravenous anesthesia Receives: Device: Intraocular pressure measurement | |
| Group S | Sevoflurane-based anesthesia Receives: Device: Intraocular pressure measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure during coronary artery bypass graft surgery with cardiopulmonary bypass
Examine the effects of propofol based total intravenous anesthesia and sevoflurane-based anesthesia methods on intraocular pressure during coronary artery bypass graft surgery operation
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start1 Sep 2021
- Primary completion3 Jan 2022
- Study completion28 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraocular PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ali Sait Kavaklı, Study director, Associate professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06494969
- Sponsor's protocol ID
- Yasemin1
- Status last verified
- May 2024
- First submitted
- 28 Jun 2024
- Last updated
- 10 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06494969
- Acronym / sponsor ID
- Yasemin1
- Conditions
- Intraocular Pressure, Anesthesia
- Keywords
- Intraocular pressure, cardiac surgery, coronary artery bypass grafting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 3 Jan 2022 (actual)
- Study completion
- 28 Jan 2022 (actual)
- First posted
- 10 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 0.1 mg/kg midazolam, 5-10 mcg/kg fentanyl, 0.5-2 mg/kg propofol, and 0.6 mg/kg rocuronium. An endotracheal tube with an internal diameter of 8-8.5 mm was used for male patients and an endotracheal tube with an internal diameter of 7-7.75 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 0.5, positive end-expiratory pressure (PEEP) at 4-5 cmH2O, tidal volume at 6-8 ml/kg 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 0.1-0.2 mg/kg 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 mg/kg/h IV propofol. In Group S, anesthesia maintenance was provided with 1-1.5 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 U/kg heparin was administered to achieve an Activated Coagulation Time (ACT) of 480 s. During CPB, non-pulsatile flow with a target flow rate of 2.2-2.5 l/min/m2 was applied, and body temperature was maintained between 32-34°C. 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 36-37°C, 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 < 0.05). 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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group P | – | Device: Intraocular pressure measurementPropofol-based total intravenous anesthesia |
| Group S | – | Device: Intraocular pressure measurementSevoflurane-based anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective coronary artery bypass grafting surgery with cardiopulmonary bypass (CPB) were included.
Key inclusion criteria (1 listed)
- Patients undergoing elective coronary artery bypass grafting surgery with cardiopulmonary bypass (CPB)
Key exclusion criteria (10 listed)
- history of cardiac surgery
- diabetic retinopathy
- cataract
- uncontrolled hypertension
- chronic kidney disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraocular pressure measurementIntraocular pressures were measured and recorded at 8 predefined time points using a tonometer; before anesthesia induction (T1), 10 min after induction (T2), immediately before the beginning of CPB (T3), 3 minute after the beginning of CPB (T4), 3 minute after cross-clamping (T5), 3min after cross-clamp removal (T6), immediately before the weaning of CPB (T7), and end of the surgery (immediately after skin closure) (T8). | Device | Group P, Group S |
Primary outcome
Intraocular pressure during coronary artery bypass graft surgery with cardiopulmonary bypass
Time frame: Through study completion, an average of 6 months
Examine the effects of propofol based total intravenous anesthesia and sevoflurane-based anesthesia methods on intraocular pressure during coronary artery bypass graft surgery operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Intraocular Pressure
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Automated Applanation Tonometry - Updated
Glaucoma, Glaucoma, Suspect
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Not yet recruiting
Glaucoma Drop Aids Part 2
Glaucoma, Intraocular Pressure
Not yet recruitingPhase 4
Iopidine to Decrease Intraocular Pressure Rise After Injections
Macular Degeneration, Diabetic Retinopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Sait Kavaklı study director
Associate professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intraocular Pressure and Anesthesia, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular pressure during coronary artery bypass graft surgery with cardiopulmonary bypass (time frame: Through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2024.