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Cognitive Functions on Coronary Surgery

The Effect of Intraoperative Arterial Oxygen Levels on Cognitive Functions After Coronary Bypass Graft Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04725708
Enrollment
100
Registered
2021-01-27
Start date
2019-11-01
Completion date
2020-08-01
Last updated
2023-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurocognitive Disorders

Keywords

cardiovascular surgery, cerebral oxymetre, neurocognitive assessment

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.

Interventions

PROCEDUREprocedure: 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.

Sponsors

Bursa Yuksek Ihtisas Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
postoperative neurocognitive function12 hours after surgeryChange on MMSE is important for neurocognitive disorder.The MMSE consists of cognitive functions of orientation, attention, calculation, memory and language.

Secondary

MeasureTime frameDescription
Extubation time after surgeryDuring the hospitalization for postoperative recovery ,average 8 daysWeaning times from mechanical ventilation among patients who are followed up with the same intensive care approach after surgery

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026