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
Qualifiers
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
Treatments tested in this trial
- Insulin, human
- Intranasal Normal Saline (Placebo)
Treatment groups
210 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
Weidong Mi
Lead sponsor
Chinese PLA General Hospital
Sponsor institution
Source ClinicalTrials.gov