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A randomized-controlled trial to look for sleep pattern of patients operated with hip replacement surgery after taking a sleeping pill (trazodone).

Assessment of sleep quality with trazodone in patients undergoing total hip arthroplasty (THA): A randomized control study - Sleep in THA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/02/031562
Enrollment
80
Registered
2021-02-25
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

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

Conditions

Health Condition 1: M169- Osteoarthritis of hip, unspecified

Interventions

Intervention1: Trazodone 50mg: The treatment group will receive trazodone 50 mg orally for one month starting from 2 days before surgery to 4 weeks after total hip replacement surgery. Control Interve

Sponsors

AIIMS Bhubaneswar
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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 Timepoint: 1, 3, 5, 14, 28, and 90 days—

Countries

India

Contacts

Public ContactSujit Kumar Tripathy

All india Institute of Medical Sciences, Bhubaneswar

sujitortho@aiimsbhubaneswar.edu.in9438884155

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 27, 2026