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

NCT05586347 | Completed

• 1 other identifier: hongweishi
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Bypass Grafting; Cardiopulmonary Bypass

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• Regional cerebral oxygen

  Before induction of anesthesia

• Regional cerebral oxygen

  Surgical skin excision

• Regional cerebral oxygen

  During cardiopulmonary bypass

• Regional cerebral oxygen

  After cardiopulmonary bypass

• Mini-mental State Examination scale score

  1 day before surgery

Study Arms (2)

group N

EXPERIMENTAL

Nicardipine was infused after initiation of CPB

Drug: Nicardipine

group C

PLACEBO COMPARATOR

Give the same volume of normal saline

Other: normal saline

Interventions

Nicardipine DRUG

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

Also known as: Astellas Pharmaceuticals (China) Co., LTD；Sinopharm approved number J20160048/ Registration number H20160015

group N

normal saline OTHER

It has the same capacity as group N。

Also known as: Hunan Kelun Pharmaceutical Co., LTD；Sinopharm approved H43020456

group C

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• : Age 60-80
• : ASA Ⅱ-Ⅲ, NYHAⅠ-Ⅲ, EF ≥50%
• : CABG under cardiopulmonary bypass

You may not qualify if:

• : Patients who had second heart surgery
• : Patients with intellectual disabilities, deafness or other impairments in normal communication
• : Previous neurosurgical procedures and history of cerebral infarction
• : cancer
• : Patients with moderate to severe carotid artery stenosis before operation
• : Patients with obvious abnormal liver and kidney function affecting drug metabolism
• : Patients taking psychotropic drugs
• : Alcoholism, drug addiction, drug dependence
• : The cardiopulmonary bypass time was greater than 120 minutes

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Hongwei Shi

Nanjing, Jiangsu, 210006, China

Location

MeSH Terms

Interventions

Nicardipine; Saline Solution

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• hongwei shi

  Director of anesthesiology department of Nanjing First Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the anesthesia department

Study Record Dates

• First Submitted: October 13, 2022
• First Posted: October 19, 2022
• Study Start: April 22, 2022
• Primary Completion: September 22, 2022
• Study Completion: September 30, 2022
• Last Updated: October 19, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)