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NCT Number: NCT07720479

Intranasal Insulin for Postoperative Delirium in Older Patients With T2DM

Postoperative delirium (POD) is highly prevalent in older patients with type 2 diabetes mellitus (T2DM). Cerebral insulin resistance is considered a key pathophysiological mechanism underlying this association. This study aims to investigate whether intranasal insulin (INI) can prevent POD and early postoperative cognitive decline by improving cerebral insulin resistance. We will conduct a randomized, double-blind, placebo-controlled multicenter trial. Older T2DM patients will be randomly assigned to receive intranasal insulin at doses of 40 IU or 80 IU, or placebo. The primary objective is to evaluate the efficacy of INI in preventing POD and to determine the dose-response relationship.

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Key information

Conditions

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

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of type 2 diabetes mellitus (T2DM) according to the World Health Organization (WHO) criteria.
  • Age ≥ 65 years.
  • Scheduled for elective hepatobiliary tumor resection with an anticipated surgical duration of ≥ 2 hours.
  • Voluntary provision of written informed consent by the patient or their legally authorized representative.

Exclusion criteria

  • Preoperative diagnosis of dementia, or an education-adjusted Mini-Mental State Examination (MMSE) score indicating cognitive impairment (illiteracy < 17, primary education < 20, secondary education or above < 24).
  • Severe visual, auditory, or language impairments precluding the completion of neurocognitive assessments.
  • American Society of Anesthesiologists (ASA) physical status classification ≥ IV.
  • History of severe central nervous system disorders (e.g., Parkinson's disease, stroke within the past 6 months, severe traumatic brain injury) or schizophrenia; or chronic use of antipsychotic or antidepressant medications.
  • Nasal anatomical abnormalities or pathologies that may compromise intranasal drug absorption (e.g., severe allergic rhinitis, severe deviated septum, recent nasal trauma or surgery, nasal polyps).
  • Known hypersensitivity to insulin or any of its excipients.
  • Extremely poor glycemic control (e.g., HbA1c > 10%), or an episode of severe hypoglycemia or diabetic ketoacidosis within the 3 months prior to enrollment.

Treatment and study plan

Insulin, human

Drug

Subjects will receive intranasal insulin treatment. The specific dosage will vary by study arm: Group 1 receives 40 IU daily (20 IU twice daily), Group 2 receives 80 IU daily (40 IU twice daily), and the control group receives intranasal placebo. Administration occurs 15 minutes prior to anesthesia induction and continues daily from postoperative day 1 through postoperative day 7.Intranasal insulin

Intranasal Normal Saline (Placebo)

Drug

0.9% sodium chloride solution for intranasal administration, matched in volume and appearance to the insulin preparation. Administered via the same nasal spray device twice daily (equivalent volume to the 80 IU insulin arm) beginning 15 min before anesthesia induction and continuing postoperatively until POD 7.

Primary outcomes

  1. Postoperative Delirium

    Time frame: Postoperative Day 1 to Postoperative Day 7

    The occurrence of postoperative delirium will be assessed using the 3D-CAM (3-Minute Diagnostic Interview for CAM). Assessments will be conducted twice daily (at 09:00-10:00 and 16:00-17:00) from postoperative day 1 through postoperative day 7.

Secondary outcomes

  1. Postoperative Mild Cognitive Impairment (MCI)

    Time frame: Postoperative Day 7, 1 Month, and 6 Months

    Assessment of postoperative mild cognitive impairment (MCI) will be conducted using the Ascertain Dementia 8-item Informant Questionnaire (AD8). The AD8 is a brief screening tool rated by informants (caregivers or family members). A total score of ≥ 2 on the AD8 will indicate the presence of cognitive impairment.

  2. Postoperative Short-term Memory Impairment

    Time frame: Postoperative Day 7, 1 Month, and 6 Months

    Short-term memory will be assessed using the Three Words Delayed Recall Test (often referred to as TRT in this study). Patients are asked to recall three unrelated words previously presented. Failure to correctly recall all three words will be considered indicative of short-term memory impairment.

Other outcomes

  1. Incidence of Postoperative Adverse Events

    Time frame: Within 30 days after surgery

    Incidence of adverse events within 30 days after surgery, including cardiovascular events, ischemic stroke, pulmonary infection, and acute kidney injury.

  2. Postoperative Pain Severity (NRS 0-10)

    Time frame: Daily for the first 7 days after surgery

    Postoperative pain severity will be assessed using the Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates "no pain" and 10 represents "the worst imaginable pain".

Study contacts

Contact information is provided by the study sponsor or research team.

Danyang Geng

CONTACT

[email protected]

17367522284

Sponsors and collaborators

Lead sponsor

Weidong Mi

Other

Registry information

Official study title

Intranasal Insulin for Prevention of Postoperative Delirium in Older Patients With Type 2 Diabetes: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 22, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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