Cardiopulmonary Bypass Clinical Trial
Official title:
Relationship Between Perioperative Carotid Blood Flow Monitoring and Cerebral Function Protection in Cardiac Surgery
Verified date | October 2022 |
Source | Nanjing First Hospital, Nanjing Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 64 |
Est. completion date | September 30, 2022 |
Est. primary completion date | September 22, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 60 Years to 80 Years |
Eligibility | Inclusion Criteria: - 1: Age 60-80 2: ASA ?-?, NYHA?-?, 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 |
Country | Name | City | State |
---|---|---|---|
China | Hongwei Shi | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Nanjing First Hospital, Nanjing Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Internal carotid blood flow | Blood flow through the internal carotid artery was measured per minute by ultrasound | Before induction of anesthesia | |
Primary | Internal carotid blood flow | Blood flow through the internal carotid artery was measured per minute by ultrasound | Surgical skin excision | |
Primary | Internal carotid blood flow | Blood flow through the internal carotid artery was measured per minute by ultrasound | During cardiopulmonary bypass | |
Primary | Internal carotid blood flow | Blood flow through the internal carotid artery was measured per minute by ultrasound | After cardiopulmonary bypass | |
Secondary | Regional cerebral oxygen | After the forehead skin is degreased and dried with alcohol,attach the NIRS probe. | Before induction of anesthesia | |
Secondary | Regional cerebral oxygen | After the forehead skin is degreased and dried with alcohol,attach the NIRS probe. | Surgical skin excision | |
Secondary | Regional cerebral oxygen | After the forehead skin is degreased and dried with alcohol,attach the NIRS probe. | During cardiopulmonary bypass | |
Secondary | Regional cerebral oxygen | After the forehead skin is degreased and dried with alcohol,attach the NIRS probe. | After cardiopulmonary bypass | |
Secondary | 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 | |
Secondary | 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. | |
Secondary | 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 | |
Secondary | 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. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04084301 -
Impact of Cardiopulmonary Bypass Flow on Renal Oxygenation, Blood Flow and Tubular Injury
|
N/A | |
Completed |
NCT04062396 -
Comparison of Remowell 2 and Inspire on Delirium and Cognitive Dysfunction
|
N/A | |
Completed |
NCT02518087 -
Increased Adsorption Membranes During Cardiopulmonary Bypass
|
N/A | |
Recruiting |
NCT01231776 -
Acupuncture Improves Sleep in Patients Undergoing Cardiopulmonary Bypass
|
N/A | |
Completed |
NCT00747331 -
Fenoldopam and Splanchnic Perfusion During Cardiopulmonary Bypass
|
Phase 4 | |
Terminated |
NCT00176657 -
The Use of HEMOBAG to Salvage Blood After Cardiac Surgery
|
Phase 2 | |
Completed |
NCT00161733 -
Safety and Hemostatic Efficacy of Fibrin Sealant Vapor Heated, Solvent/Detergent Treated (FS VH S/D) Compared With Currently Licensed TISSEEL VH Fibrin Sealant in Subjects Undergoing Cardiac Surgery
|
Phase 3 | |
Completed |
NCT05537168 -
Bayesian Networks in Pediatric Cardiac Surgery
|
||
Completed |
NCT05525195 -
Influence of Preop Fibrinogen on Blood in Pediatric Cardiac Surgery
|
||
Completed |
NCT04238806 -
Desflurane,Brain Natriuretic Peptide and Cardiac Surgery
|
N/A | |
Completed |
NCT00981474 -
Cerebral Autoregulation Monitoring During Cardiac Surgery
|
N/A | |
Recruiting |
NCT05588011 -
Influence of Oxygenator Selection on Platelet Function and Rotational Thromboelastometry Following Cardiopulmonary Bypass
|
N/A | |
Completed |
NCT02566733 -
Minto Model in Effect Site Mode for Target-Controlled Infusion of Remifentanil During Cardiopulmonary Bypass
|
Phase 4 | |
Terminated |
NCT00385450 -
Cardiopulmonary Bypass-Induced Lymphocytopenia and the Potential Effects of Protease Inhibitor
|
Phase 1 | |
Completed |
NCT00246740 -
Protection of the Heart With Doxycycline During Coronary Artery Bypass Grafting
|
Phase 2 | |
Not yet recruiting |
NCT05075265 -
Pharmacokinetics of Methadone in Adults Undergoing Cardiac Surgery With Extracorporeal Circulation
|
||
Recruiting |
NCT04296071 -
Neutrophil Phenotypic Profiling and Acute Lung Injury in Patients After Cardiopulmonary Bypass (CPB)
|
||
Completed |
NCT05579964 -
The Role of Dexmedetomidine as Myocardial Protector in Pediatric Cardiac Surgery Total Correction of Tetralogy of Fallot
|
Phase 2/Phase 3 | |
Active, not recruiting |
NCT04133740 -
Oxygenation Targets in Cardiac Surgery Patients - a Before-and-after Study
|
Phase 4 | |
Completed |
NCT05033236 -
Platelets and Complement Activation in Coronary Artery Bypass Graft Surgery (CABG)
|