Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Age 65 to 80 years. Elective lower limb orthopedic surgery. Expected surgical duration more than or equal to 90 minutes. Planned spinal anesthesia. ASA Physical Status I to III. Able to communicate in English or Hindi. Adequate hearing. Willing to provide informed consent.
Exclusion criteria
Exclusion criteria: Pre existing dementia or delirium MMSE less than 24 or clinically significant cognitive impairment Severe hearing impairment Chronic opioid use for more than 3 months Substance abuse disorder Participation in another interventional clinical trial Conversion to general anesthesia Block failure requiring rescue anesthesia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of postoperative delirium assessed using the Confusion Assessment MethodTimepoint: At six hours twelve hours twenty four hours and forty eight hours after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative pain severity measured using Numeric Rating Scale NRSTimepoint: At six hours twelve hours twenty four hours & forty eight hours after surgery;State anxiety measured using State Trait Anxiety InventoryTimepoint: Before surgery & at six hours & forty eight hours after surgery;Total intraoperative sedative requirementTimepoint: During surgery;Patient satisfaction measured using Five point Likert ScaleTimepoint: At forty eight hours after surgery;Hospital length of stayTimepoint: At hospital discharge | — |
Countries
India
Contacts
Dr S N Medical College