A study to investigate if melatonin can improve sleep in hospital after abdominal surgery or Orthopaedic Surgery, including Hips and Knees.

Melatonin to Improve Sleep in Patients Undergoing Major Abdominal Surgery or Orthopaedic Surgery, including Hips and Knees: A Double-blind, Randomised Placebo-controlled Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12620000031965

Acronym

Melrose

Enrollment

340

Registered

2020-01-20

Start date

2020-08-17

Completion date

2023-09-20

Last updated

2026-07-13

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

Conditions

None listed

Brief summary

The primary purpose of this project is to determine whether the use of melatonin improves the quality of sleep in patients undergoing major abdominal and orthopaedic (hip and knee) surgery. Melatonin is a natural hormone secreted by the pineal gland. Melatonin, when administered at night, promotes sleep by helping to regulate the body's circadian clock and sleep-wake cycles. It is well known that sleep quality in hospitals is poor and can lead to insufficient sleep, thereby reducing natural immune function. Major abdominal surgery leads to the release of both pro-inflammatory and anti-inflammatory chemical in the blood.. Melatonin may be an effective adjunctive medication not only to improve sleep but also to dampen the inflammatory response after surgery.

Interventions

Melatonin 5mg wafer once daily sublingual whilst in hospital from day 1 post surgery up to 7 days or until discharge if prior to 7 days. The doses will be prescribed via the electronic medication chart and this will be reviewed to confirm compliance to administration.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

All English-speaking patients 18 years and over undergoing elective/semi-elective major abdominal surgery with an anticipated length of stay greater than 48 hours.

Exclusion criteria

Patients from the above group will be excluded if they: • Are unable to give written informed consent to take part in the study, • Patients who require the use of a trained healthcare interpreter to be able to understand study information. • Lack decision-making capacity, • Expected stay less than 48 hours, • Concurrent use of benzodiazepine, non-benzodiazepine (Z-drugs) or melatonin, • Alcohol consumption > 13 units/week for women and >20 units/week for men. • Currently taking melatonin • Drug interaction with melatonin. • Allergy to melatonin or its excipients (may contain lactose) • Decreased renal function as defined by an eGFR of <30 mL/min/1.73m2 • Decreased liver function defined as an AST > 500 U/L or ALT >500 U/L • Pregnant or breastfeeding females • Enrolment in other clinical trials involving an investigational agent • Taking quinolones, carbamazepine and rifampicin, fluvoxamine, 5- or 8- methoxypsoralen, cimetidine, oestrogens.

Outcome results