Clinical trial NCT05586347: Relationship Between Perioperative Carotid Blood Flow Monitoring and Cerebral Function Protection in Cardiac Surgery
Official title: Relationship Between Perioperative Carotid Blood Flow Monitoring and Cerebral Function Protection in Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Bypass Grafting
Cardiopulmonary Bypass
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2022-10-19
Enrollment: 64
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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）.

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

Primary outcomes:
measure: Internal carotid blood flow
timeFrame: Before induction of anesthesia
measure: Internal carotid blood flow
timeFrame: Surgical skin excision
measure: Internal carotid blood flow
timeFrame: During cardiopulmonary bypass
measure: Internal carotid blood flow
timeFrame: After cardiopulmonary bypass
Secondary outcomes:
measure: Regional cerebral oxygen
timeFrame: Before induction of anesthesia
measure: Regional cerebral oxygen
timeFrame: Surgical skin excision
measure: Regional cerebral oxygen
timeFrame: During cardiopulmonary bypass
measure: Regional cerebral oxygen
timeFrame: After cardiopulmonary bypass
measure: Mini-mental State Examination scale score
timeFrame: 1 day before surgery
measure: Mini-mental State Examination scale score
timeFrame: 7 days after surgery.
measure: Neuron specific endase
timeFrame: Before induction of anesthesia
measure: Neuron specific endase
timeFrame: 2 hours after surgery.
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Hongwei Shi
state: Jiangsu
Study officials:
affiliation: Director of anesthesiology department of Nanjing First Hospital
name: hongwei shi
role: STUDY_DIRECTOR
References: