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

• Status: Recruiting
• Trial end date: 2024-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yangzhou University
• Treatments: Insulin

Criteria

Inclusion Criteria:

1. 100 patients with elective first cardiac surgery, aged 18-80 years, who agreed to participate in the trial and signed an informed consent form.

2. Patients with diabetes mellitus, if any, were regularly treated and had preoperative fasting glucose ≤180 mg/dL (10 mmol/L).

3. No consciousness or speech impairment and able to cooperate with neurological physical examinations, cognitive function tests and other neurological functional assessments.

4. 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.

5. No preoperative anxiety or depression, with a Hamilton Anxiety Scale (HAMA) score ≤ 7 and a Hamilton Depression Scale (HAMD) score ≤ 7.

6. 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.

7. Correction of anemia, hypoproteinemia and other nutritional status prior to surgery.

Exclusion Criteria:

1. Emergency cardiac surgery.

2. Non-CPB cardiac surgery.

3. Severe heart failure with left ventricular ejection fraction <30%.

4. Contraindications to TEE.

5. Renal disease requiring replacement therapy.

6. Combined multi-organ insufficiency.

7. Severe infection requiring continuous antibiotic therapy.

8. Significant application of hormonal or non-steroidal anti-inflammatory agents within the last 2 weeks.

9. Neurological or psychiatric diagnoses that could affect neurocognitive performance or neurocognitive testing, such as severe traumatic brain injury or substance abuse.

10. Prior neurodegenerative or psychiatric disorders.

11. Severe audiovisual impairment and inability to communicate.