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Completed

NCT Number: NCT04725708

Cognitive Functions on Coronary Surgery

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.

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Key information

Conditions

Neurocognitive Disorders Mental Disorders

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bursa YIERH

Bursa, 16200, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

procedure: cerebral oxygenation intervention

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.

Primary outcomes

  1. postoperative neurocognitive function

    Time frame: 12 hours after surgery

    Change on MMSE is important for neurocognitive disorder.The MMSE consists of cognitive functions of orientation, attention, calculation, memory and language.

  2. postoperative neurocognitive function

    Time frame: 24 hours after surgery

    Change on MMSE is important for neurocognitive disorder.The MMSE consists of cognitive functions of orientation, attention, calculation, memory and language.

  3. postoperative neurocognitive function

    Time frame: 1 month after surgery

    Change on MMSE is important for neurocognitive disorder.The MMSE consists of cognitive functions of orientation, attention, calculation, memory and language.

  4. postoperative neurocognitive function

    Time frame: 3 months after surgery

    Change on MMSE is important for neurocognitive disorder.The MMSE consists of cognitive functions of orientation, attention, calculation, memory and language.

  5. postoperative neurocognitive function

    Time frame: 6 months after surgery

    Change on MMSE is important for neurocognitive disorder.The MMSE consists of cognitive functions of orientation, attention, calculation, memory and language.

Secondary outcomes

  1. Extubation time after surgery

    Time frame: During the hospitalization for postoperative recovery ,average 8 days

    Weaning times from mechanical ventilation among patients who are followed up with the same intensive care approach after surgery

Sponsors and collaborators

Lead sponsor

Bursa Yuksek Ihtisas Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 27, 2021
Registry last updated
Mar 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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