A Clinical Study to Explore the Protective Effect of Insulin on Perioperative Cardioencephalon in Patients Undergoing Cardiac Surgery Based on Low-dose Insulin Relaxation Blood Glucose Technology
Study Details
Study Description
Brief Summary
Perioperative hyperglycaemia can contribute to complications such as cardiac and cerebral dysfunction in patients undergoing cardiac surgery. Regulating blood glucose levels too high or too low will have a detrimental effect on the patient. Insulin has cardioprotective and cerebral effects. This project adopts a low-dose insulin relaxation glucose technique to enable insulin to play a cardiac and cerebral protective role, and at the same time regulate perioperative blood glucose levels well, so as to build a rapid recovery system for perioperative cardiac and cerebral functions in cardiac surgery patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Glucose-insulin-potassium
|
Drug: Glucose insulin potassium
After induction of anaesthesia,cardiac systolic-diastolic function was first measured by TEE, GIK solution was continuously pumped until the end of the procedure at a dose of 30 mU/kg/h of insulin, 0.12 g/kg/h of glucose and 0.06 mmol/kg/h of potassium chloride
|
| No Intervention: Control
|
Outcome Measures
Primary Outcome Measures
- Changes in left ventricular systolic function [from 30 minutes after intubation to 1 hour after intubation , from 30minutes before the end of the surgery to the end of the surgery]
Left ventricular systolic function changes such as EDV, ESV, EF are assessed by TEE
- Changes in right ventricular systolic function [from 30 minutes after intubation to 1 hour after intubation , from 30minutes before the end of the surgery to the end of the surgery]
Right ventricular systolic function changes, such as TAPSE, are assessed by TEE
- Changes in left ventricular diastolic function [from 30 minutes after intubation to 1 hour after intubation , from 30minutes before the end of the surgery to the end of the surgery]
Changes in left ventricular diastolic function are assessed by TEE, such as mitral valve E/A ratio, E peak deceleration time, and changes in pulmonary venous blood flow
- Changes in right ventricular diastolic function [from 30 minutes after intubation to 1 hour after intubation , from 30minutes before the end of the surgery to the end of the surgery]
Right ventricular diastolic function changes such as tricuspid valve E/A ratio and changes in hepatic venous blood flow are assessed by TEE
- Changes in blood flow in the coronary sinuses [from 30 minutes after intubation to 1 hour after intubation , from 30minutes before the end of the surgery to the end of the surgery]
TEE assessment of coronary sinus flow changes, such as maximum systolic flow, maximum diastolic flow, TVIs, TVId, maximum coronary sinus internal diameter
- Changes in myocardial performance index [from 30 minutes after intubation to 1 hour after intubation , from 30minutes before the end of the surgery to the end of the surgery]
ET, IVCT, IVRT are measured by TEE to calculate the myocardial performance index
- Changes in the level of CAM-ICU scale score [1,2,3,7 days after surgery]
First, evaluate the patient's state of consciousness based on the patient's behavior, and decide whether to proceed with the next evaluation based on the state of consciousness. If the next step is to be evaluated, ask the patient related questions to score, and evaluate whether the patient has delirium based on the score.
- Changes in the level of Delirium Rating Scale,(DRS-R-98) scale score [1,2,3,7 days after surgery]
Use the questions on the scale to assess the patient's degree of delirium
- Changes in the level of Mini-Men-tal State Examination scale score [1,2,3,7,30 days after surgery]
Assess the cognitive function of the patient by asking questions on the patient scale
- Changes in cerebral blood flow [The day before surgery and 1,6,12,24,48h after surgery]
Cerebral flow tests are performed by TCD, such as systolic peak flow velocity (Vs), end-diastolic peak flow velocity (Vd), mean blood flow velocity (Vm), beat index (PI), resistance index (RI), and Doppler spectrogram
Secondary Outcome Measures
- Changes in the level of Systolic Blood Pressure/Diastolic Blood Pressure(Mean Arterial Pressure) [into ICU 30 minutes]
The above results should be measured immediately after induction, at the beginning of surgery, after administration of protamine, and at the end of surgery
- Changes in the level of Cardiac output [into ICU 30 minutes]
The above results should be measured immediately after induction, at the beginning of surgery, after administration of protamine, and at the end of surgery
- Changes in the level of Heart Rate [into ICU 30 minutes]
The above results should be measured immediately after induction, at the beginning of surgery, after administration of protamine, and at the end of surgery
- Changes in the level of SVI [into ICU 30 minutes]
The above results should be measured immediately after induction, at the beginning of surgery, after administration of protamine, and at the end of surgery
- Changes in the level of SVR [into ICU 30 minutes]
The above results should be measured immediately after induction, at the beginning of surgery, after administration of protamine, and at the end of surgery
- Changes in the level of SVRI [into ICU 30 minutes]
The above results should be measured immediately after induction, at the beginning of surgery, after administration of protamine, and at the end of surgery
- Changes in the level of Cardiac index [into ICU 30 minutes]
The above results should be measured immediately after induction, at the beginning of surgery, after administration of protamine, and at the end of surgery
Eligibility Criteria
Criteria
Inclusion Criteria:
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100 patients with elective first cardiac surgery, aged 18-80 years, who agreed to participate in the trial and signed an informed consent form.
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Patients with diabetes mellitus, if any, were regularly treated and had preoperative fasting glucose ≤180 mg/dL (10 mmol/L).
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No consciousness or speech impairment and able to cooperate with neurological physical examinations, cognitive function tests and other neurological functional assessments.
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No preoperative neurocognitive impairment, Mini Mental State Examination (MMSE) score: illiterate ≥ 17, primary school ≥ 20, secondary school and above ≥ 24, and Montreal Cognitive Assessment (MoCA) score ≥ 26. 26 points.
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No preoperative anxiety or depression, with a Hamilton Anxiety Scale (HAMA) score ≤ 7 and a Hamilton Depression Scale (HAMD) score ≤ 7.
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Pre-operative neurological physical examination National Institute of Health Stroke Scale (NIHSS) score ≤ 4, no new intracranial infarction, bleeding, tumour, inflammation, etc. within 3 months prior to surgery.
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Correction of anemia, hypoproteinemia and other nutritional status prior to surgery.
Exclusion Criteria:
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Emergency cardiac surgery.
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Non-CPB cardiac surgery.
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Severe heart failure with left ventricular ejection fraction <30%.
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Contraindications to TEE.
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Renal disease requiring replacement therapy.
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Combined multi-organ insufficiency.
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Severe infection requiring continuous antibiotic therapy.
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Significant application of hormonal or non-steroidal anti-inflammatory agents within the last 2 weeks.
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Neurological or psychiatric diagnoses that could affect neurocognitive performance or neurocognitive testing, such as severe traumatic brain injury or substance abuse.
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Prior neurodegenerative or psychiatric disorders.
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Severe audiovisual impairment and inability to communicate.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | the Affiliated Hospital of Yangzhou University, Yangzhou University | Yangzhou | Jiangsu | China |
Sponsors and Collaborators
- Yangzhou University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20220515