Mechanisms and Intervention Strategies of Perioperative Glycemic Variability on Postoperative Delirium

Condition(s) studied

Investigational drug(s) / intervention(s)

Intranasal insulin-20U: Intranasal insulin intervention was administered by a trained nurse at a dose of 20IU. The timing and frequency of the intervention were as follows: twice daily starting from 2 days before surgery; one dose administered 60 minutes before anesthesia induction; and twice daily from postoperative day 1 to day 3. Safety monitoring during the intervention was performed by one cardiac surgeon.

Intranasal insulin-40U: Intranasal insulin intervention was administered by a trained nurse at a dose of 40IU. The timing and frequency of the intervention were as follows: twice daily starting from 2 days before surgery; one dose administered 60 minutes before anesthesia induction; and twice daily from postoperative day 1 to day 3. Safety monitoring during the intervention was performed by one cardiac surgeon.

Intranasal Saline: Intranasal saline was administered by a trained nurse at a dose of 1 mL per administration (0.5 mL per nostril). The timing and frequency of the intervention were as follows: twice daily starting 2 days before surgery; one dose given 60 minutes before anesthesia induction; and twice daily from postoperative day 1 to day 3. Safety monitoring during the intervention was performed by one cardiac surgeon.

Study summary

Delirium is a sudden change in attention, thinking, and awareness that can occur after heart surgery. It may slow recovery and is associated with longer hospital stays and poorer health outcomes. Patients undergoing heart surgery with cardiopulmonary bypass, also known as a heart-lung machine, may experience changes in blood sugar levels and in the body's response to insulin around the time of surgery.

This study aims to investigate how fluctuations in blood sugar levels, known as glycemic variability, are related to postoperative delirium. It will also examine whether insulin resistance, a condition in which the body responds less effectively to insulin, helps explain this relationship.

The study will evaluate intranasal insulin, which is insulin administered through the nose to reach the brain. Researchers will assess its effects on blood sugar fluctuations, insulin resistance, and the occurrence of postoperative delirium in patients undergoing heart surgery with cardiopulmonary bypass. The findings may help guide future approaches to protecting brain function and improving recovery after heart surgery.

Eligibility

Primary outcome measure(s)

• Number and Proportion of Participants with Postoperative Delirium Assessed Using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) Within 7 Days After Surgery — Postoperative days 1 through 7
  Postoperative delirium will be assessed using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) during postoperative days 1 through 7. The number and proportion of participants who develop postoperative delirium during this period will be reported. Delirium will be identified according to the CAM-ICU assessment criteria.

Trial sites (1)

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