The Effect of Melatonin on Postoperative Delirium in Elderly ICU Patients

Delirium Clinical Trial

Official title:

The Effect of Melatonin on Postoperative Delirium in Elderly ICU Patients : Randomized, Placebo-controlled, Double Blind Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02588742
• Other study ID #: 4-2014-1038
• Status: Terminated
• Phase: N/A
• Start date: February 2, 2015
• Est. completion date: January 15, 2016

Study information

• Verified date: February 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: January 15, 2016
• Est. primary completion date: January 15, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• older than 50 years old

• patients who admitted to ICU after surgery

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

Related Conditions & MeSH terms

• Delirium

Intervention

Dietary Supplement:
• 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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of delirium	The score of ICD-SC(Intensive Care Delirium Screening Checklist) will be recorded to identify the incidence of delirium for 5 days after surgery.	5 days after surgery
Secondary	change of amount of used vasopressors as a measure of intraoperative hemodynamics	intra-procedural hemodynamics measured by amount of used vasopressors	up to 5 days
Secondary	total amount of sedatives		up to 5 days
Secondary	total amount of analgesics		up to 5 days
Secondary	duration of mechanical ventilation		up to 5 days
Secondary	duration of ICU stay		up to 5 days