Cognitive Functions on Coronary Surgery

NCT04725708 | Completed

• 1 other identifier: Bursa YIERH
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurocognitive Disorders

Keywords

cardiovascular surgery; cerebral oxymetre; neurocognitive assessment

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (1)

• Extubation time after surgery

  During the hospitalization for postoperative recovery ,average 8 days

Study Arms (2)

normoxy

EXPERIMENTAL

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.

Procedure: procedure: cerebral oxygenation intervention

hyperoxia

EXPERIMENTAL

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.

Procedure: procedure: cerebral oxygenation intervention

Interventions

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.

hyperoxia; normoxy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients scheduled to undergo elective cardiopulmonary bypass graft surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Bursa Yuksek Ihtisas Training and Research Hospital: lead

Study Sites (1)

Bursa YIERH

Bursa, 16200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neurocognitive Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Tuğba T ONUR, MD

  Bursa Yuksek Ihtisas Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• Ümran Ü KARACA, MD

  Bursa Yuksek Ihtisas Training and Research Hospital

  STUDY CHAIR

• Filiz F ATA, MD

  Bursa Yuksek Ihtisas Training and Research Hospital

  STUDY CHAIR

• Halil Erkan H SAYAN, MD

  Bursa Yuksek Ihtisas Training and Research Hospital

  STUDY CHAIR

• Anıl A ONUR, MD

  Bursa Yuksek Ihtisas Training and Research Hospital

  STUDY CHAIR

• Canan C YILMAZ, MD

  Bursa Yuksek Ihtisas Training and Research Hospital

  STUDY CHAIR

• Ayşe Neslihan AN BALKAYA, MD

  Bursa Yuksek Ihtisas Training and Research Hospital

  STUDY CHAIR

• Cüneyt C ERİŞ

  Bursa Yuksek Ihtisas Training and Research Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: January 27, 2021
• Study Start: November 1, 2019
• Primary Completion: May 1, 2020
• Study Completion: August 1, 2020
• Last Updated: March 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)