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

October 17, 2022 updated by: Hongwei Shi, Nanjing First Hospital, Nanjing Medical University
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Internal carotid blood flow
Time Frame: Before induction of anesthesia
Blood flow through the internal carotid artery was measured per minute by ultrasound
Before induction of anesthesia
Internal carotid blood flow
Time Frame: Surgical skin excision
Blood flow through the internal carotid artery was measured per minute by ultrasound
Surgical skin excision
Internal carotid blood flow
Time Frame: During cardiopulmonary bypass
Blood flow through the internal carotid artery was measured per minute by ultrasound
During cardiopulmonary bypass
Internal carotid blood flow
Time Frame: After cardiopulmonary bypass
Blood flow through the internal carotid artery was measured per minute by ultrasound
After cardiopulmonary bypass

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Regional cerebral oxygen
Time Frame: Before induction of anesthesia
After the forehead skin is degreased and dried with alcohol,attach the NIRS probe.
Before induction of anesthesia
Regional cerebral oxygen
Time Frame: Surgical skin excision
After the forehead skin is degreased and dried with alcohol,attach the NIRS probe.
Surgical skin excision
Regional cerebral oxygen
Time Frame: During cardiopulmonary bypass
After the forehead skin is degreased and dried with alcohol,attach the NIRS probe.
During cardiopulmonary bypass
Regional cerebral oxygen
Time Frame: After cardiopulmonary bypass
After the forehead skin is degreased and dried with alcohol,attach the NIRS probe.
After cardiopulmonary bypass
Mini-mental State Examination scale score
Time Frame: 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.
1 day before surgery
Mini-mental State Examination scale score
Time Frame: 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 days after surgery.
Neuron specific endase
Time Frame: 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.
Before induction of anesthesia
Neuron specific endase
Time Frame: 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.
2 hours after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nanjing First Hospital, Nanjing Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: hongwei shi, Director of anesthesiology department of Nanjing First Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 22, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 22, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 13, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 19, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 19, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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