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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05586347
Enrollment
64
Registered
2022-10-19
Start date
2022-04-22
Completion date
2022-09-30
Last updated
2022-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiopulmonary Bypass, Coronary Artery Bypass Grafting

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).

Interventions

DRUGNicardipine

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

OTHERnormal saline

It has the same capacity as group N。

Sponsors

Nanjing First Hospital, Nanjing Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Internal carotid blood flowBefore induction of anesthesiaBlood flow through the internal carotid artery was measured per minute by ultrasound

Secondary

MeasureTime frameDescription
Regional cerebral oxygenBefore induction of anesthesiaAfter the forehead skin is degreased and dried with alcohol,attach the NIRS probe.
Mini-mental State Examination scale score1 day before surgeryIlliteracy 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 endaseBefore induction of anesthesia3ml 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026