Comparison Between the Effect of Two Different Doses of Oral Melatonin on Sleep Quality After Total Hip Arthroplasty

ConditionSleep Disturbance

Trial statusNot yet recruiting

Trial phaseEarly Phase 1

Trial typeInterventional

Biological sexAll

Age18-80

SponsorBenha University

About this trial

Considering the fact that melatonin was safely and effectively used in higher doses in multiple surgical conditions , the present study hypothesized that increasing melatonin dose in THA would have better benefits for patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Elective unilateral total hip arthroplasty.

Disqualifiers

Revision arthroplasty

documented sleep disorders requiring treatment,

use of other sleep medications preoperatively

known melatonin allergy or contraindication.

Trial design

Design model

Parallel

Treatments tested in this trial

Melatonin 5 MG
Drug
Melatonin 5 mg and one placebo sugar tablet oral tablet, two hours preoperatively and for 14 nights postoperatively.
Melatonin 10 MG
Drug
Two melatonin 5 mg oral tablet, two hours preoperatively and for 14 nights postoperatively.
Placebo
Other intervention
Two placebo sugar tablets, two hours preoperatively and for 14 nights postoperatively.

Treatment groups

150 Participants

are divided into 3 treatment groups

Group A: 5mg groupExperimental treatment 1 intervention

Group B: 10mg groupExperimental treatment 1 intervention

Group C: Control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Sleep Quality

Patient-Reported Outcomes Measurement Information System (PROMIS) for sleep quality

Time frame

14 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Benha University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: