Cognitive Functions on Coronary Surgery

Neurocognitive Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04725708
• Other study ID #: Bursa YIERH
• Status: Completed
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: August 1, 2020

Study information

• Verified date: March 2023
• Source: Bursa Yüksek Ihtisas Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 1, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Neurocognitive Disorders

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Turkey	Bursa YIERH	Bursa

Sponsors (1)

Lead Sponsor	Collaborator
Bursa Yüksek Ihtisas Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative neurocognitive function	Change on MMSE is important for neurocognitive disorder.The MMSE consists of cognitive functions of orientation, attention, calculation, memory and language.	12 hours after surgery
Primary	postoperative neurocognitive function	Change on MMSE is important for neurocognitive disorder.The MMSE consists of cognitive functions of orientation, attention, calculation, memory and language.	24 hours after surgery
Primary	postoperative neurocognitive function	Change on MMSE is important for neurocognitive disorder.The MMSE consists of cognitive functions of orientation, attention, calculation, memory and language.	1 month after surgery
Primary	postoperative neurocognitive function	Change on MMSE is important for neurocognitive disorder.The MMSE consists of cognitive functions of orientation, attention, calculation, memory and language.	3 months after surgery
Primary	postoperative neurocognitive function	Change on MMSE is important for neurocognitive disorder.The MMSE consists of cognitive functions of orientation, attention, calculation, memory and language.	6 months after surgery
Secondary	Extubation time after surgery	Weaning times from mechanical ventilation among patients who are followed up with the same intensive care approach after surgery	During the hospitalization for postoperative recovery ,average 8 days