Cognitive Functions on Coronary Surgery

NCT ID: NCT04725708

Last Updated: 2023-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2020-08-01

Brief Summary

The aim of this study is to examine the effects of different but safe levels of arterial oxygen levels used in cardiac surgeries on cerebral oxygenation during the operation. It is also to investigate the effect on cognitive functions in the postoperative period. For our study the investigators will conduct a randomized control trial. Patients will be randomly assigned to one of two possible study groups according to the arterial oxygen levels.If there is any abnormality in cerebral oxygen levels during surgery, necessary intervention will be made by doctors.

Detailed Description

In most cardiovascular surgeries, patients are frequently followed up at hyperoxemic level for safety purposes against the risk of tissue hypoxia that may develop during surgery due to CPB use. At the level of hyperoxemia, there are opinions that the ischemia-reperfusion damage increases with the follow-up of CABG surgery, microcirculation is impaired and tissue oxygenation is impaired due to the resulting hyperoxemic vasoconstriction. Recent research has focused on evaluating optimal oxygen levels in CPB during cardiac surgery. However, the potential of tightly regulated intraoperative normoxia to improve POCD following cardiac surgery has not been studied prospectively.

The purpose of this study is to determine whether patients who underwent CPB and CABG, which were preserved under normoxic conditions during the intraoperative period, would have a lower incidence of early and late POCD than those exposed to hyperoxia.

Conditions

Neurocognitive Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

normoxy

Group 1(n=50) FiO2%40, PaO2<180 ve PaO2≥80mmHg MMSE will be applied to patients before surgery. At the determined measurement times body and blood temperature, SpO2, HR, MAP, PH, blood gas lactate, blood gas base deficit, urine output, PaO2, PaCO2, Htc, FiO2, right and left rSO2 values were monitored.

An rSO2 less than 45% triggered an alarm, the anesthesiologist timed the event, and after 60 seconds initiated an intervention protocol means; PaO2 levels were checked, PaO2> 100 mmHg was achieved, if not improved, pump blood flow, mean arterial pressure were increased, if there is still no response and hematocrit <20%, patients were scheduled for erythrocyte transfusion until the rSO2 was restored to at least 60% at both probes.In the postoperative period, at the 24th hour, when routine cardiological controls were performed 1., 3., 6. Simultaneous MMSE will be repeated in months.

Group Type: EXPERIMENTAL

procedure: cerebral oxygenation intervention

Intervention Type: PROCEDURE

During the surgery, cerebral oxygenation will be followed and intervention will be made to pH, PaO2, PaCO2, mean arterial pressure, hematocrit when necessary. In addition perfusion flow was maintained at or close to between 2.2-2.5 L/min/m2 . Perfusion pressure was adjusted using a phenylephrine infusion to maintain a mean arterial pressure of 50 to 70 mm Hg.

hyperoxia

Group 2(n=50) FiO2%100, PaO2≥180mmHg MMSE will be applied to patients before surgery. At the determined measurement times body and blood temperature, SpO2, HR, MAP, PH, blood gas lactate, blood gas base deficit, urine output, PaO2, PaCO2, Htc, FiO2, right and left rSO2 values were monitored..In the postoperative period, at the 24th hour, when routine cardiological controls were performed 1., 3., 6. Simultaneous MMSE will be repeated in months.

Group Type: EXPERIMENTAL

procedure: cerebral oxygenation intervention

Intervention Type: PROCEDURE

During the surgery, cerebral oxygenation will be followed and intervention will be made to pH, PaO2, PaCO2, mean arterial pressure, hematocrit when necessary. In addition perfusion flow was maintained at or close to between 2.2-2.5 L/min/m2 . Perfusion pressure was adjusted using a phenylephrine infusion to maintain a mean arterial pressure of 50 to 70 mm Hg.

Interventions

procedure: cerebral oxygenation intervention

During the surgery, cerebral oxygenation will be followed and intervention will be made to pH, PaO2, PaCO2, mean arterial pressure, hematocrit when necessary. In addition perfusion flow was maintained at or close to between 2.2-2.5 L/min/m2 . Perfusion pressure was adjusted using a phenylephrine infusion to maintain a mean arterial pressure of 50 to 70 mm Hg.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• adult patients scheduled to undergo elective cardiopulmonary bypass graft surgery

Exclusion Criteria

• severe preoperative cognitive impairment(i.e. dementia, intellectual disorder)
• Non-Turkish speaking patients
• presence of end-stage organ failure
• patients requiring emergency coronary surgery
• surgical procedures requiring single lung ventilation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bursa Yuksek Ihtisas Training and Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Tugba Onur

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tuğba T ONUR, MD

Role: PRINCIPAL_INVESTIGATOR

Bursa Yuksek Ihtisas Training and Research Hospital

Ümran Ü KARACA, MD

Role: STUDY_CHAIR

Bursa Yuksek Ihtisas Training and Research Hospital

Filiz F ATA, MD

Role: STUDY_CHAIR

Bursa Yuksek Ihtisas Training and Research Hospital

Halil Erkan H SAYAN, MD

Role: STUDY_CHAIR

Bursa Yuksek Ihtisas Training and Research Hospital

Anıl A ONUR, MD

Role: STUDY_CHAIR

Bursa Yuksek Ihtisas Training and Research Hospital

Canan C YILMAZ, MD

Role: STUDY_CHAIR

Bursa Yuksek Ihtisas Training and Research Hospital

Ayşe Neslihan AN BALKAYA, MD

Role: STUDY_CHAIR

Bursa Yuksek Ihtisas Training and Research Hospital

Cüneyt C ERİŞ

Role: STUDY_CHAIR

Bursa Yuksek Ihtisas Training and Research Hospital

Locations

Bursa YIERH

Bursa, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Bursa YIERH

Identifier Type: -

Identifier Source: org_study_id