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Clinical Trials/NCT05586347
NCT05586347
Completed
Not Applicable

Relationship Between Perioperative Carotid Blood Flow Monitoring and Cerebral Function Protection in Cardiac Surgery

Nanjing First Hospital, Nanjing Medical University1 site in 1 country64 target enrollmentApril 22, 2022

Overview

Phase
Not Applicable
Intervention
Nicardipine
Conditions
Coronary Artery Bypass Grafting
Sponsor
Nanjing First Hospital, Nanjing Medical University
Enrollment
64
Locations
1
Primary Endpoint
Internal carotid blood flow
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Postoperative cognitive dysfunction (POCD) is a common complication of cardiac surgery, mainly manifested as mental confusion, anxiety, personality change and memory impairment, which seriously affects the quality of life of patients after surgery.Attention should be paid to the protection of neurological function in patients undergoing cardiac surgery during perioperative period.Nicardipine can selectively act on coronary arteries and cerebral vessels, increase coronary artery and cerebral blood flow, relieve coronary heart disease angina pectoris, protect brain tissue.The cerebral protective effect of nicardipine on cardiovascular surgery under CPB deserves further clinical study.About 15-20% of cardiac output (CO) in healthy adults is allocated to the brain , and cerebral blood flow is supplied by bilateral internal carotid artery (ICA) and vertebral artery (VA), among which ICA provides about 70%-80% of cerebral perfusion flow .However, the location of the internal carotid artery is superficial, the anatomical variation is less, and the ultrasonic Doppler technique is portable and simple to measure. It may be of certain clinical value to use the ultrasonic detection technology to quickly evaluate the cerebral perfusion during the perioperative period, and to early detect and avoid the intraoperative brain function injury.

Detailed Description

Patients who were scheduled to undergo open-heart surgery under cardiopulmonary bypass were randomly divided into nicardipine group (group N) and normal saline control group (group C) by the digital table method. Group N was pumped with nicardipine 0.2-0.5μg/(kg·min) after CPB, while group C was given the same volume of normal saline. The basic hemodynamic parameters, rScO2, BIS, maximum systolic velocity of internal carotid artery (PSV-ICA), end-diastolic velocity of internal carotid artery (EDV-ICA), diameter of internal carotid artery (D-ICA), internal carotid artery blood flow (Q-ICA) and cerebral blood flow ratio (CBF/CO) were observed and recorded in the two groups at each time point ), cerebrovascular resistance (CVR) and the concentration of NSE, a biomarker of brain injury.The following hypothesis is proposed: during CPB, pump nicardipine can dilate the internal carotid artery and cerebral arterioles, increase cerebral blood flow, improve cerebral oxygen supply, and reduce the risk of postoperative cognitive dysfunction(POCD).

Registry
clinicaltrials.gov
Start Date
April 22, 2022
End Date
September 30, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hongwei Shi

Head of the anesthesia department

Nanjing First Hospital, Nanjing Medical University

Eligibility Criteria

Inclusion Criteria

  • 1: Age 60-80
  • 2: ASA Ⅱ-Ⅲ, NYHAⅠ-Ⅲ, EF ≥50%
  • 3: CABG under cardiopulmonary bypass

Exclusion Criteria

  • 1: Patients who had second heart surgery
  • 2: Patients with intellectual disabilities, deafness or other impairments in normal communication
  • 3: Previous neurosurgical procedures and history of cerebral infarction
  • 5: Patients with moderate to severe carotid artery stenosis before operation
  • 6: Patients with obvious abnormal liver and kidney function affecting drug metabolism
  • 7: Patients taking psychotropic drugs
  • 8: Alcoholism, drug addiction, drug dependence
  • 9: The cardiopulmonary bypass time was greater than 120 minutes

Arms & Interventions

group N

Nicardipine was infused after initiation of CPB

Intervention: Nicardipine

group C

Give the same volume of normal saline

Intervention: normal saline

Outcomes

Primary Outcomes

Internal carotid blood flow

Time Frame: After cardiopulmonary bypass

Blood flow through the internal carotid artery was measured per minute by ultrasound

Secondary Outcomes

  • Regional cerebral oxygen(After cardiopulmonary bypass)
  • Mini-mental State Examination scale score(7 days after surgery.)
  • Neuron specific endase(2 hours after surgery.)

Study Sites (1)

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