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

• Sponsor: Nanjing First Hospital, Nanjing Medical University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05586347
• Collaborator: (none)
• Enrollment: 64
• Location: 1
• Arms: 2
• Actual Duration (Months): 5.3
• Patients Per Site Per Month: 12.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Bypass Grafting; Cardiopulmonary Bypass	Drug: Nicardipine; Other: normal saline	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 64 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Relationship Between Perioperative Carotid Blood Flow Monitoring and Cerebral Function Protection in Cardiac Surgery
• Actual Study Start Date: Apr 22, 2022
• Actual Primary Completion Date: Sep 22, 2022
• Actual Study Completion Date: Sep 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Internal carotid blood flow [Before induction of anesthesia]

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

2. Internal carotid blood flow [Surgical skin excision]

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

3. Internal carotid blood flow [During cardiopulmonary bypass]

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

4. Internal carotid blood flow [After cardiopulmonary bypass]

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

Secondary Outcome Measures

1. Regional cerebral oxygen [Before induction of anesthesia]

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

2. Regional cerebral oxygen [Surgical skin excision]

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

3. Regional cerebral oxygen [During cardiopulmonary bypass]

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

4. Regional cerebral oxygen [After cardiopulmonary bypass]

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

5. Mini-mental State Examination scale score [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 [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 [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hongwei Shi	Nanjing	Jiangsu	China	210006

Sponsors and Collaborators

• Nanjing First Hospital, Nanjing Medical University

Investigators

• Study Director: hongwei shi, Director of anesthesiology department of Nanjing First Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hongwei Shi, Head of the anesthesia department, Nanjing First Hospital, Nanjing Medical University
• ClinicalTrials.gov Identifier: NCT05586347
• Other Study ID Numbers: hongweishi
• First Posted: Oct 19, 2022
• Last Update Posted: Oct 19, 2022
• Last Verified: Oct 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Nicardipine

Study Results

No Results Posted as of Oct 19, 2022