A study to investigate if melatonin can improve sleep in hospital after abdominal surgery.

Phase 3

Active, not recruiting

• Conditions: Abdominal surgery; Alternative and Complementary Medicine - Other alternative and complementary medicine; Sleep disturbance; Surgery - Other surgery

• Registration Number: ACTRN12620000031965
• Lead Sponsor: Hunter New England Local Health District.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-20
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 152

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified