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

NCT ID: NCT05586347

Last Updated: 2022-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-22
• Study Completion Date: 2022-09-30

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）.

Conditions

Coronary Artery Bypass Grafting; Cardiopulmonary Bypass

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

group N

Nicardipine was infused after initiation of CPB

Group Type: EXPERIMENTAL

Nicardipine

Intervention Type: DRUG

Nicardipine 0.2-0.5μg/(kg·min) was infused at the beginning of CPB.

group C

Give the same volume of normal saline

Group Type: PLACEBO_COMPARATOR

normal saline

Intervention Type: OTHER

It has the same capacity as group N。

Interventions

Nicardipine

Nicardipine 0.2-0.5μg/(kg·min) was infused at the beginning of CPB.

Intervention Type: DRUG

normal saline

It has the same capacity as group N。

Intervention Type: OTHER

Other Intervention Names

Astellas Pharmaceuticals (China) Co., LTD；Sinopharm approved number J20160048/ Registration number H20160015; Hunan Kelun Pharmaceutical Co., LTD；Sinopharm approved H43020456

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

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Hongwei Shi

Head of the anesthesia department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

hongwei shi

Role: STUDY_DIRECTOR

Director of anesthesiology department of Nanjing First Hospital

Locations

Hongwei Shi

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

hongweishi

Identifier Type: -

Identifier Source: org_study_id