Melatonin Treatment After Laparoscopic Cholecystectomy

University Hospital, Gentofte, Copenhagen

Status and phase: Completed; Phase 3; Phase 2

Conditions: Postoperative Complications; Dyssomnias; Fatigue

Treatments: Drug: melatonin

Study type: Interventional

Funder types: Other

Identifiers

NCT00113906

2004-003796-37

Details and patient eligibility

About

Circadian disturbances occur after surgery. A double blinded, placebo controlled randomized clinical trial was made to investigate effects of melatonin on postoperative fatigue, sleep disturbances and general wellbeing.

Full description

Postoperative fatigue and sleep disturbances occur after minimally invasive surgery. The pathophysiological background is unknown, but several studies have shown disturbed melatonin secretion after surgery. It is unknown whether melatonin substitution will improve general wellbeing, fatigue or sleep disturbances after laparoscopic cholecystectomy. We set out to study in a randomized clinical trial to investigate the effect of 5 mg melatonin versus placebo, on postoperative sleep disturbances, fatigue and general wellbeing.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Operation for gall bladder disease
• Age over 18 years

Exclusion criteria

• Known preoperative sleep disturbance
• Anticoagulant therapy
• Psychiatric disease
• Lack of written informed consent
• Treatment with hypnotics within one week prior to surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind