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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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**

Other trials in Turkey (Türkiye)

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.

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 groups in NCT06494969
Study groupRoleWhat they receive
Group PPropofol-based total intravenous anesthesia
Receives: Device: Intraocular pressure measurement
Group SSevoflurane-based anesthesia
Receives: Device: Intraocular pressure measurement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted10 Jul 2024
  2. Study start1 Sep 2021
  3. Primary completion3 Jan 2022
  4. Study completion28 Jan 2022

Resources

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)
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

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.

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