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Completed

NCT Number: NCT05586347

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

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.

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Key information

Conditions

Coronary Artery Bypass Grafting Cardiopulmonary Bypass

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hongwei Shi

Nanjing, Jiangsu, 210006, China

About this study

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）.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

nicardipine

Drug

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

Other names: Astellas Pharmaceuticals (China) Co., LTD；Sinopharm approved number J20160048/ Registration number H20160015

Normal Saline

Other

It has the same capacity as group N。

Other names: Hunan Kelun Pharmaceutical Co., LTD；Sinopharm approved H43020456

Primary outcomes

  1. Internal carotid blood flow

    Time frame: Before induction of anesthesia

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

  2. Internal carotid blood flow

    Time frame: Surgical skin excision

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

  3. Internal carotid blood flow

    Time frame: During cardiopulmonary bypass

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

  4. Internal carotid blood flow

    Time frame: After cardiopulmonary bypass

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

Secondary outcomes

  1. Regional cerebral oxygen

    Time frame: Before induction of anesthesia

    After the forehead skin is degreased and dried with alcohol,attach the NIRS probe.

  2. Regional cerebral oxygen

    Time frame: Surgical skin excision

    After the forehead skin is degreased and dried with alcohol,attach the NIRS probe.

  3. Regional cerebral oxygen

    Time frame: During cardiopulmonary bypass

    After the forehead skin is degreased and dried with alcohol,attach the NIRS probe.

  4. Regional cerebral oxygen

    Time frame: After cardiopulmonary bypass

    After the forehead skin is degreased and dried with alcohol,attach the NIRS probe.

  5. Mini-mental State Examination scale score

    Time frame: 1 day before 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.

  6. Mini-mental State Examination scale score

    Time frame: 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.

  7. Neuron specific endase

    Time frame: Before induction of anesthesia

    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.

  8. Neuron specific endase

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Oct 19, 2022
Registry last updated
Oct 19, 2022

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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