A randomized-controlled trial to look for sleep pattern of patients operated with hip replacement surgery after taking a sleeping pill (trazodone).
Not Applicable
- Conditions
- Health Condition 1: M169- Osteoarthritis of hip, unspecified
- Registration Number
- CTRI/2021/02/031562
- Lead Sponsor
- AIIMS Bhubaneswar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.To look for sleep disturbance and sleep quality after THA using Pittsburgh Sleep Quality Index (PSQI), in patients taking trazodone vs placebo
Exclusion Criteria
1.Patients undergoing revision total hip arthroplasty
2.Patients with previous history of sleep apnoea, sleep disorder, use of sedatives or hypnotics, alcohol abuse and complex sleep behaviour
3.Patients with neurological disorder such as psychiatric illness, Parkinsonism, dementia etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To look for sleep disturbance and sleep quality after THA using Pittsburgh Sleep Quality Index (PSQI), in patients taking trazodone vs placeboTimepoint: 1, 3, 5, 14, 28, and 90 days
- Secondary Outcome Measures
Name Time Method Day time sleepiness using Epworth Sleepiness Scale (ESS), amount of analgesic use, pain (VAS), functional outcome (modified Harris Hip score), quality of life (EQ-5D/5L) and length of hospital stay, evaluate the effect of age, sex, BMI, comorbidities (ASA grade), aetiology, anxiety/ depression ( Hamilton anxiety and depression scale) on both the groups <br/ ><br>Timepoint: 1, 3, 5, 14, 28, and 90 days