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Effect of Nicotine Replacement Therapy on Delirium and Cognitive Function After Surgery in Tobacco Users: A Double-Blind Randomized Trial

Nicotine Replacement Therapy reduces the incidence of Delirium and Cognitive Dysfunction in Post Operative period in abstinent tobacco smokers: A Double Blind Randomized Controlled Trial - NA

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/05/087578
Enrollment
100
Registered
2025-05-26
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

Health Condition 1: F05- Delirium due to known physiological condition

Interventions

Intervention1: Nicotine patches : Nicotine patch will be administered from one day prior to surgery every 24 hours till discharge of the patients [TTS 30, by Novartis (30 cm2, containing total 52.5 mg

Sponsors

Dr Puneet Khanna
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients between the age group of 18 years to 80 years. 2.Patient with a history of smoking on a daily basis. 3.ASA I and ASA II. 4.There is no minimum cognitive performance required to participate

Exclusion criteria

Exclusion criteria: 1) Patients with Body Mass Index (BMI) greater than 30 kg/m , cardiovascular diseases, hepatic encephalopathy, or serious renal dysfunction. 2) Patients with a history suggestive of dementia, neurological disorders, stroke, or who have undergone cerebral surgeries. 3) Patients with a history of alcohol abuse, chronic opioid use, or other forms of substance abuse. 4) Patients with psychiatric illnesses such as schizophrenia, anxiety disorders, or any other condition affecting cognition or causing mental dysfunction. 5)Patients currently prescribed central nervous system active medications such as antidepressants, antipsychotics, or sedatives.

Design outcomes

Primary

MeasureTime frame
we anticipate to be able to justify the use of nicotine patch in abstinent smokers as a replacement therapy to reduce the incidence of delirium and cognitive dysfunction in the post operative period.Timepoint: one day prior to surgery every 24 hours till discharge of the patients

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactDr Puneet Khanna

AIIMS, Ansari Nagar, New Delhi

k.punit@yahoo.com9873106516

Outcome results

None listed

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