Mechanisms and Intervention Strategies of Perioperative Glycemic Variability on Postoperative Delirium

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• Emergence Delirium 788

Emergence Delirium

788 studies on the registry are indexed under Emergence Delirium; 250 are open to participants now.

This study's planned enrollment of 225 is above the median of 120 across 491 interventional studies indexed under Emergence Delirium.

Lead sponsor

Fujian Medical University Union Hospital is the lead sponsor of 104 studies on the registry; 76 are open to participants now.

Study arms

• Experimental
  Group I-20

  Intranasal insulin intervention was administered by a trained nurse at a dose of 0.5 mL per administration (0.25 mL per nostril). 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.

  Drug: Intranasal insulin-20U

• Experimental
  Group I-40

  Intranasal insulin intervention 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 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.

  Drug: Intranasal insulin-40U

• Placebo comparator
  Control group

  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.

  Drug: Intranasal Saline

Interventions

• DrugIntranasal 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.

• DrugIntranasal 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.

• DrugIntranasal 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.

Primary outcomes

1. 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 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.

   Time frame: Postoperative days 1 through 7

Secondary outcomes

1. Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) at Baseline, at the End of Cardiopulmonary Bypass, and on Postoperative Days 1, 2, 3, and 7

   Insulin resistance will be assessed using the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR). HOMA-IR will be calculated using blood glucose and insulin concentrations according to the prespecified study protocol. HOMA-IR values will be recorded at the preoperative baseline, at the end of cardiopulmonary bypass (CPB), and on postoperative days 1, 2, 3, and 7. The HOMA-IR values at each assessment time point will be reported.

   Time frame: Preoperative baseline, at the end of cardiopulmonary bypass, and postoperative days 1, 2, 3, and 7

2. Perioperative Glycemic Variability Assessed by Mean Blood Glucose (MBG), Coefficient of Variation (CV), Mean Absolute Glucose Measure, Derived Time in Range (dTIR), and Mean of Daily Differences (MODD)

   Perioperative glycemic variability will be evaluated using blood glucose measurements obtained through intermittent sampling at prespecified time points. The assessment parameters will include mean blood glucose (MBG), coefficient of variation (CV), mean absolute glucose measure, derived time in range (dTIR), and mean of daily differences (MODD). Blood glucose measurements will be collected at the following time points: preoperative baseline (fasting blood glucose on hospital admission day 1); 15 minutes before anesthesia induction; within the first hour after initiation of cardiopulmonary bypass (CPB); within 10 minutes after termination of CPB; and four times daily at 6-hour intervals on postoperative days 1 through 3. Each glycemic variability parameter will be calculated according to the prespecified study protocol, and the corresponding values will be reported for the applicable assessment period.

   Time frame: Preoperative baseline; 15 minutes before anesthesia induction; within the first hour after initiation of CPB; within 10 minutes after termination of CPB; and postoperative days 1 through 3, with four measurements per day at 6-hour intervals.

Individual participant data

Plan to share: No