Intranasal Insulin for Postoperative Delirium in Older Patients With T2DM
ConditionPostoperative Delirium (POD)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorWeidong Mi
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Insulin, human
DrugSubjects 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)
Drug0.9% 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.
Treatment groups
210 Participants
are divided into 3 treatment groupsGroup A: Intranasal Insulin 40 IU GroupExperimental treatment 1 intervention
Group B: Intranasal Insulin 80 IU GroupExperimental treatment 1 intervention
Group C: Control GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Postoperative Delirium
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.
Time frame
Postoperative Day 1 to Postoperative Day 7Secondary outcomes
1
Postoperative Mild Cognitive Impairment (MCI)
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.
Time frame
Postoperative Day 7, 1 Month, and 6 Months2
Postoperative Short-term Memory Impairment
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.
Time frame
Postoperative Day 7, 1 Month, and 6 MonthsOther outcomes
1
Incidence of Postoperative Adverse Events
Incidence of adverse events within 30 days after surgery, including cardiovascular events, ischemic stroke, pulmonary infection, and acute kidney injury.
Time frame
Within 30 days after surgery2
Postoperative Pain Severity (NRS 0-10)
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".
Time frame
Daily for the first 7 days after surgeryLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Weidong Mi
Lead sponsor
Chinese PLA General Hospital
Sponsor institution
Source ClinicalTrials.gov
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