A study to investigate if melatonin can improve sleep in hospital after abdominal surgery.
Melatonin to Improve Sleep in Patients Undergoing Major Abdominal Surgery: A Double-blind, Randomised Placebo-controlled Trial
Hunter New England Local Health District.
340 participants
Aug 17, 2020
Interventional
Conditions
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 surgery. Melatonin is a natural hormone secreted by the pineal gland. Melatonin when given at night works to promote sleep by helping to regulate the body's bio clock and sleep-wake cycles. It is well known that sleep quality in hospital is poor and can cause insufficient sleep which reduces natural immune function. Major abdominal surgery leads to the release of both pro-inflammatory and anti-inflammatory chemical in the blood.. Melatonin could be an effective adjunct medication not only to assist in improving sleep but to dampen the inflammatory response after surgery.
Eligibility
Inclusion Criteria1
- 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 Criteria15
- 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.
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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.
Locations(2)
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ACTRN12620000031965