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.

Study Overview

• Status: Completed
• Conditions: Cardiopulmonary Bypass; Coronary Artery Bypass Grafting
• Intervention / Treatment: Drug: Nicardipine; Other: normal saline

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 Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210006
      • Hongwei Shi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group N; Nicardipine was infused after initiation of CPB	Drug: Nicardipine; 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
Placebo Comparator: group C; Give the same volume of normal saline	Other: normal saline; It has the same capacity as group N。; Other Names: Hunan Kelun Pharmaceutical Co., LTD；Sinopharm approved H43020456

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Internal carotid blood flow	Blood flow through the internal carotid artery was measured per minute by ultrasound	Before induction of anesthesia
Internal carotid blood flow	Blood flow through the internal carotid artery was measured per minute by ultrasound	Surgical skin excision
Internal carotid blood flow	Blood flow through the internal carotid artery was measured per minute by ultrasound	During cardiopulmonary bypass
Internal carotid blood flow	Blood flow through the internal carotid artery was measured per minute by ultrasound	After cardiopulmonary bypass

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Regional cerebral oxygen	After the forehead skin is degreased and dried with alcohol,attach the NIRS probe.	Before induction of anesthesia
Regional cerebral oxygen	After the forehead skin is degreased and dried with alcohol,attach the NIRS probe.	Surgical skin excision
Regional cerebral oxygen	After the forehead skin is degreased and dried with alcohol,attach the NIRS probe.	During cardiopulmonary bypass
Regional cerebral oxygen	After the forehead skin is degreased and dried with alcohol,attach the NIRS probe.	After cardiopulmonary bypass
Mini-mental State Examination scale score	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.	1 day before surgery
Mini-mental State Examination scale score	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 days after surgery.
Neuron specific endase	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.	Before induction of anesthesia
Neuron specific endase	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.	2 hours after surgery.

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University
• Investigators: Study Director: hongwei shi, Director of anesthesiology department of Nanjing First Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2022
• Primary Completion (Actual): September 22, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: October 13, 2022
• First Submitted That Met QC Criteria: October 17, 2022
• First Posted (Actual): October 19, 2022

Study Record Updates

• Last Update Posted (Actual): October 19, 2022
• Last Update Submitted That Met QC Criteria: October 17, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Nicardipine
• Other Study ID Numbers: hongweishi

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No