The Effect of Melatonin on Postoperative Delirium in Elderly ICU Patients

Not Applicable

Terminated

• Conditions: Delirium
• Interventions: Dietary Supplement: Melatonin; Dietary Supplement: Placebo

• Registration Number: NCT02588742
• Lead Sponsor: Yonsei University

Brief Summary

Delirium in older patients is associated with increased mortality and health care costs. And delirium is frequent in intensive care unit (ICU). Circadian rhythm alteration is one of the most important risk factor for developing delirium. In this study, investigators will investigate the effect of administration of melatonin on postoperative delirium in elderly ICU patients.

Randomly selected patients of the melatonin group are given 5mg of melatonin in the evening from the day before surgery to the the 5th postoperation day. In contrast, patients in the control group are given placebo.

Primary outcome of this study is the incidence of postoperative delirium measured by ICD-SC (Intensive Care delirium Screening Checklist). And secondary outcome includes intra-procedural hemodynamics measured by amount of used vasopressors, heart rate and blood pressure, total amount of sedatives, total amount of analgesics, duration of mechanical ventilation, duration of ICU stay.

Thus, investigators perform this study to investigate the relationship between delirium and circadian rhythm.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-02
• Study First Submitted: 2015-10-19
• Study First Submitted QC: 2015-10-27
• Study First Posted: 2015-10-28
• Primary Completion: 2016-01-15
• Study Completion: 2016-01-15
• Status Verified: 2019-02
• Last Update Submitted: 2019-03-27
• Last Update Posted: 2019-03-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

• older than 50 years old
• patients who admitted to ICU after surgery

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Exclusion Criteria

• Subjects are ineligible if they have cognitive dysfunction,
• disabling mental change disorder,
• alcohol addiction,
• dementia,
• cerebrovascular accident,
• transient ischemic attack,
• carotid artery stenosis,
• autoimmune disease,
• patients who are unable to communicate or speak Korean,
• emergent operation

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
melatonin group	Melatonin	Patients in the melatonin group are given 5mg of melatonin at 8 pm the day before surgery, POD#0, POD#1, POD#2, POD#3, POD#4, and POD#5.
control group	Placebo	Patients in the control group are given placebo at 8 pm the day before surgery, POD#0, POD#1, POD#2, POD#3, POD#4, and POD#5.

Primary Outcome Measures

Name	Time	Method
incidence of delirium	5 days after surgery	The score of ICD-SC(Intensive Care Delirium Screening Checklist) will be recorded to identify the incidence of delirium for 5 days after surgery.

Secondary Outcome Measures

Name	Time	Method
change of amount of used vasopressors as a measure of intraoperative hemodynamics	up to 5 days	intra-procedural hemodynamics measured by amount of used vasopressors
total amount of sedatives	up to 5 days
total amount of analgesics	up to 5 days
duration of mechanical ventilation	up to 5 days
duration of ICU stay	up to 5 days

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of