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

Not Applicable

Completed

• Conditions: Coronary Artery Bypass Grafting; Cardiopulmonary Bypass
• Interventions: Other: normal saline; Drug: Nicardipine

• Registration Number: NCT05586347
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

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）.

Study Timeline

• Study Start: 2022-04-22
• Primary Completion: 2022-09-22
• Study Completion: 2022-09-30
• Status Verified: 2022-10
• Study First Submitted: 2022-10-13
• Study First Submitted QC: 2022-10-17
• Last Update Submitted: 2022-10-17
• Study First Posted: 2022-10-19
• Last Update Posted: 2022-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

  4: cancer

  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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group C	normal saline	Give the same volume of normal saline
group N	Nicardipine	Nicardipine was infused after initiation of CPB

Primary Outcome Measures

Name	Time	Method
Internal carotid blood flow	After cardiopulmonary bypass	Blood flow through the internal carotid artery was measured per minute by ultrasound

Secondary Outcome Measures

Name	Time	Method
Regional cerebral oxygen	After cardiopulmonary bypass	After the forehead skin is degreased and dried with alcohol,attach the NIRS probe.
Mini-mental State Examination scale score	7 days after surgery.	Illiteracy group (no education) less than 17 points, primary school group (education ≤6 years) less than 20 points, secondary school or above group (education \> 6 years) less than 24 points, the above is normal.
Neuron specific endase	2 hours after surgery.	3ml arterial blood was collected and centrifuged. The plasma was stored in a refrigerator at -70℃ for measurement, and the concentration of NSE was determined by ELISA.

Trial Locations

Locations (1)

Hongwei Shi; 🇨🇳 Nanjing, Jiangsu, China