Intranasal Insulin for Postoperative Delirium in Older Patients With T2DM
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Insulin, human, Intranasal Normal Saline (Placebo).
- Who it may be relevant to
- Registry conditions: Postoperative Delirium (POD). Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Intranasal Insulin for Prevention of Postoperative Delirium in Older Patients With Type 2 Diabetes: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial
Overview
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.
Interventions
- Drug Insulin, human
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 - Drug Intranasal Normal Saline (Placebo)
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 outcome measures
- Postoperative Delirium [Time frame: Postoperative Day 1 to Postoperative Day 7]
Secondary outcome measures (2)
- Postoperative Mild Cognitive Impairment (MCI) [Time frame: Postoperative Day 7, 1 Month, and 6 Months]
- Postoperative Short-term Memory Impairment [Time frame: Postoperative Day 7, 1 Month, and 6 Months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07720479 · POD- INI- RCT2026 · S2026-023-01