Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: N-Acetylcysteine: Dose: Patients below 50kgs-400mg Patients above 50kgs--
600mg
Duration: Before Anaesthesia- 1 tablet 2 hours before surgery After Anaesthesia- twice daily for 2 days
Sponsors
NIL
Eligibility
Inclusion criteria
Inclusion criteria: Patients aged 55 years and older. -Scheduled for elective daycare surgery under general and spinal anaesthesia. -Capable of providing informed consent. -Patients with an American Society of Anaesthesiologists (ASA) physical status classification I-III, indicating they are generally healthy or have mild to moderate systemic disease. -Patients weighing between 40 kg and 80 kg, to ensure the appropriateness of the NAC dosing regimen. -Patients undergoing non-cardiac and non-neuro-related surgery. -Either gender of patients can be included.
Exclusion criteria
Exclusion criteria: Known allergy or contraindication to NAC. -Severe systemic diseases or unstable medical conditions. -Pre-existing cognitive impairment or neurodegenerative diseases. -Concurrent participation in another clinical trial. -Cardiac and neurosurgery patients. -Undergoing surgery for trauma. -Lack of the capacity to consent to their surgery. -Are unable to comply with the requirements of informed consent or the study protocol. -Subject who participated in any other clinical investigation using an experimental drug in the past 3 months. -Participants who are not willing to sign the ICF and to attend treatment schedule regularly. -Pre-existing psychiatric illness such as Alzheimer’s disease, or dementia. -History or current use of opioid abuse. -Ortho Surgeries involving upper limbs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effect of N-Acetylcysteine (NAC) on Postoperative cognitive dysfunction (POCD) in elderly patients undergoing day-care surgery.Timepoint: POCD is surveyed with the Mini Mental State Examination (MMSE) at initially 2 hours before surgery as a baseline score, followed by 1 hour after surgery, 6 hours after surgery, 12 hours after surgery, and 24 hours after surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| •To assess the Quality of recovery of Postoperative cognitive dysfunction (POCD) patients undergoing day-care surgery. •To assess readiness to discharge after N-acetylcysteine administration. •To monitor and report the Adverse drug reaction (ADR) of N-acetylcysteine if any. Timepoint: Measurement Tool: Standardized Quality of Recovery (QoR) questionnaires (e.g., 40 questionnaires). Outcome: Change in QoR scores from baseline to postoperative periods in each group. Discharge readiness: Using Modified Aldrete Score of score 9 or above. | — |
Countries
India
Contacts
Public ContactDR MG Rajanandh
SRM Institute of Science and Technology
Outcome results
None listed