Mechanisms and Intervention Strategies of Perioperative Glycemic Variability on Postoperative Delirium

NCT07893353 | Recruiting

• 1 other identifier: 2025KY727
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiac Surgery With Cardiopulmonary Bypass; Postoperative Delirium

Outcome Measures

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.

  Postoperative days 1 through 7

Secondary Outcomes (2)

• 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

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

• 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)

  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.

Study Arms (3)

Group I-20

EXPERIMENTAL

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

Group I-40

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

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

Intranasal insulin-20U DRUG

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.

Group I-20

Intranasal insulin-40U DRUG

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.

Group I-40

Intranasal Saline DRUG

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Scheduled for elective cardiac surgery with CPB

You may not qualify if:

• History of psychiatric disorders, neurological diseases, or mild cognitive impairment (MCI) (Mini-Cog score \< 3)
• Severe diabetes mellitus
• Participation in other interventional studies
• Coexistence of severe organic diseases
• Nasal deformities, nasal diseases, or history of nasal surgery

Sponsors & Collaborators

• Fujian Medical University Union Hospital: lead

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350000, China

RECRUITING

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Yanjuan Lin

CONTACT

+86 591 86218336; fjxhyjl@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2026
• First Posted: October 23, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): October 31, 2028
• Last Updated: October 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)