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To study the Effect of Insulin Nasal Spray in Preventing Confusion After Joint Replacement Surgery in Older Patients?

Evaluating the effect of Intranasal Regular Insulin on incidence of Postoperative Delirium in Elderly Patients Undergoing Joint Replacement,A Randomized, Triple-Blind, Placebo-Controlled study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/093198
Enrollment
90
Registered
2025-08-18
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: - Health Condition 2: M259- Joint disorder, unspecified

Interventions

Intervention1: intranasal regular insulin: Patients in interventional group will receive intranasal regular insulin (40 IU, twice daily) at 08:00 and 20:00 hours, starting 24 hours before surgery and

Sponsors

Department of Anaesthesiology, AIIMS Rishikesh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. American Society of Anaesthesiology (ASA) physical grade I-III patients of either sex 2. Preoperative Mini-Mental State Examination (MMSE) score more than or equal to 24 3. Undergoing joint replacement surgery under regional anaesthesia

Exclusion criteria

Exclusion criteria: 1. Patients who refuse to consent for the study. 2. Patients with known history of insulin allergy 3. Known case of Diabetes mellitus 4. Preoperative acute hyponatremia (serum sodium level below 135 m Eq per L) 5. Patients with severe anaemia (Haemoglobin less than 7gm per dl) 6. Obese patients with BMI more than 30 kg per m2 7. Patients with pre-existing psychiatric or neurological disease 8. Existing severe cognitive impairment or dementia. 9. History of significant neurological disorders (e.g., stroke, Parkinson?s disease). 10. Any structural abnormality in nose or nasal mucosa which hampers the administration of intranasal drug

Design outcomes

Primary

MeasureTime frame
Incidence of POD assessed using the Confusion Assessment Method (CAM) within 72 hours? post-surgery.Timepoint: The patient will be assessed for 3 days after the surgery,twice a day in the morning and evening—

Secondary

MeasureTime frame
Severity of PODTimepoint: upto 72 hours post operative, twice daily in the morning & in the evening;Pre-operative anxietyTimepoint: on the day of surgery;Cognitive recoveryTimepoint: At discharge;Length of StayTimepoint: At discharge;Adverse events related to intranasal insulinTimepoint: 24 hours preoperative period to 72 hours in the post operative period—

Countries

India

Contacts

Public ContactDr Priyanka Gupta

All India Institute of Medical Sciences,Rishikesh

drpriyankagupta84@gmail.com9811894899

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026