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临床试验/NCT05586347
NCT05586347已完成不适用

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

Nanjing First Hospital, Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2022年4月22日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
64
试验地点
1
主要终点
Internal carotid blood flow

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
60 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

group N

Experimental

Nicardipine was infused after initiation of CPB

干预措施: Nicardipine (Drug)

group C

Placebo Comparator

Give the same volume of normal saline

干预措施: normal saline (Other)

结局指标

主要结局

Internal carotid blood flow

时间窗: After cardiopulmonary bypass

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

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hongwei Shi

Head of the anesthesia department

Nanjing First Hospital, Nanjing Medical University

研究点 (1)

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