Comparison Between the Effect of Two Different Doses of Oral Melatonin on Sleep Quality After Total Hip Arthroplasty | NCT07732725

NCT07732725

Overview

NCT ID: NCT07732725
Lead Sponsor: Benha UniversityOTHER
Official Title: Comparison Between the Effect of Two Different Doses of Oral Melatonin on Sleep Quality After Total Hip Arthroplasty A Randomized Placebo-Controlled Double-Blind Trial
Brief Summary: 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.
Conditions: Sleep Disturbance
Interventions: Melatonin 5 MG
Melatonin 10 MG

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Elective unilateral total hip arthroplasty.

Exclusion Criteria:

Revision arthroplasty

documented sleep disorders requiring treatment,

use of other sleep medications preoperatively

known melatonin allergy or contraindication.

Participant Group/Arms

5mg groupExperimental

Melatonin 5 mg and one placebo sugar tablet oral tablet, two hours preoperatively and for 14 nights postoperatively.

Drug: Melatonin 5 MG

10mg groupExperimental

Two melatonin 5 mg oral tablet, two hours preoperatively and for 14 nights postoperatively.

Drug: Melatonin 10 MG

Control groupPlacebo Comparator

Two placebo sugar tablets, two hours preoperatively and for 14 nights postoperatively.

Other: Placebo