Cognitive Functions on Coronary Surgery

Not Applicable

Completed

• Conditions: Neurocognitive Disorders

• Registration Number: NCT04725708
• Lead Sponsor: Bursa Yüksek İhtisas Education and Research Hospital

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.

Study Timeline

• Study Start: 2019-11-01
• Primary Completion: 2020-05-01
• Study Completion: 2020-08-01
• Study First Submitted: 2021-01-20
• Study First Submitted QC: 2021-01-23
• Study First Posted: 2021-01-27
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-28
• Last Update Posted: 2023-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
postoperative neurocognitive function	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 Outcome Measures

Name	Time	Method
Extubation time after surgery	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

Trial Locations

Locations (1)

Bursa YIERH; 🇹🇷 Bursa, Turkey