Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: Probiotics: Lab4 Consortium (12.5 billion CFU per capsule) 2 daily
preoperatively one day and postoperatively 3 days
Control Intervention1: placebo
: Microcrystalline cellulose 250 m
Sponsors
SRM Medical College and Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1. Elective primary orthopedic surgery patients. 2. Patients providing written informed consent. 3. ASA 1-3 4. No history of chronic gastrointestinal disease liver dysfunction or cognitive disorder
Exclusion criteria
Exclusion criteria: 1. Pre-existing neurological or psychiatric illness (e.g., dementia, stroke, major depression). 2. Active infection or chronic inflammatory and autoimmune disease. 3. Recent (greater than 2 weeks) use of corticosteroids, antibiotics, or immunosuppressants. 4. Emergency surgery. 5. Chronic renal disease 6. Allergies to probiotics.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of postoperative cognitive dysfunction assessed using the Montreal Cognitive Assessment (MoCA) tool in patients undergoing elective orthopedic surgery receiving probiotic supplementation compared with placebo.Timepoint: Montreal Cognitive Assessment (MoCA) tool will be used to assess patients in 4 time points: preoperative baseline, postoperative day 1, postoperative day 2, and postoperative day 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in serum zonulin levels as a biomarker of intestinal permeability & gut barrier integrity & its association with postoperative cognitive dysfunction reflecting gut brain axis activity in patients receiving probiotic supplementation compared with placebo.Timepoint: Baseline sample before surgery Early inflammatory response day 1 POCD evaluation period day 3;Change in serum soluble Triggering Receptor Expressed on Myeloid cells 2 (sTREM2) levels as a biomarker of neuroinflammation & its association with postoperative cognitive dysfunction reflecting gut brain axis interaction in patients receiving probiotic supplementation compared with placebo.Timepoint: Baseline sample before surgery Early inflammatory response (day 1) POCD evaluation period day 3;Correlation between serum zonulin & sTREM2 levels to explore the relationship between intestinal permeability & neuroinflammation in the gut brain axis.Timepoint: Baseline sample before surgery Early inflammatory response (day 1) POCD evaluation period (day 3);Subgroup analysis to evaluate the influence of perioperative factors on postoperative cognitive dysfunction & gut brain axis biomarkers, including type of anesthesia, pain management strategy, patient age group, & surgical site (upper limb versus lower limb orthopedic surgery).Timepoint: Baseline sample before surgery Early inflammatory response (day 1) POCD evaluation period (day 3) | — |
Countries
India
Contacts
Public ContactDR Karthik K
SRM medical college and hospital SRM Nagar Potheri
Outcome results
None listed