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Completed

NCT Number: NCT02478736

Preoperative Transcranial Doppler as a Predictor for Delirium Following On-pump Cardiac Surgery

Postoperative delirium is an important problem in patients undergoing major cardiac surgery and associated with more complicated hospital course, increased hospital length of stay and total postoperative cost. A study shows that a low preoperative cerebral oximetry (rSO2) is associated with postoperative delirium after on-pump cardiac surgery. Another study showed that patients who underwent cardiac surgery with reduced cerebral blood flow (CBF) velocity in the left middle cerebral artery (MCA) preoperatively are at greater risk for postoperative cognitive dysfunction (POCD). Therefore, the investigators hypothesize that lower perioperative rSO2 and reduced preoperative mean flow velocity (MFV) of MCA are good predictors of the postoperative delirium in the patients undergoing the on-pump cardiac surgery.

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Key information

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients in the study will be 60 or older undergoing elective major on-pump cardiac surgery

Exclusion criteria

  • No communication possible due to a language barrier or deafness
  • Patients diagnosed with neurocognitive disorders or psychiatric diseases (MMSE or Geriatric Depression Scale cannot be checked before surgery)
  • Patients with unstable hemodynamics or intubated before surgery
  • Patients diagnosed with significant (≥ 50%) intracranial stenosis confirmed by CT angiography or MR angiography
  • Patients diagnosed with stroke, TIA or neurologic diseases (e.g. Parkinson's disease, epilepsy, dementia, or taking psychiatric medications d/t psychiatric disorders)

Treatment and study plan

No actual intervention

Other

Contact with enrolled subjects requires application of ceberal oximetry electrodes and the preoperative ultrasound (transcranial doppler) of the both MCA. No actual intervention done to subject.

Primary outcomes

  1. the predictive power of perioperative MFV of MCA regarding postoperative delirium

    Time frame: 7 days from postoperation

    The presence and severity of delirium were assessed with Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) once a day. The investigators plan to evaluate whether perioperative rSO2 and/or MFV of MCA can predict postoperative delirium in patients undergoing the on-pump cardiac surgery and to assess the predictive power of perioperative rSO2/MFV of MCA regarding postoperative delirium. Perioperative rSO2 was observed during surgery (an expected average of 4 hours) and MVF of MCA was measured just before the induction of general anesthesia.

  2. the predictive power of periopertiver rSO2 values regarding postoperative delirium

    Time frame: 7 days from postoperation

    To evaluate whether periopertiver MFV of MCA and/or rSO2 can predict postoperative delirium in patients undergoing the on-pump cardiac surgery

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 23, 2015
Registry last updated
Jan 8, 2018

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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