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The Effect of Melatonin on Postoperative Delirium in Elderly ICU Patients

Primary Purpose

Delirium

Status
Terminated
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Melatonin
Placebo
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Delirium focused on measuring elderly ICU patients

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

melatonin group

control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

change of amount of used vasopressors as a measure of intraoperative hemodynamics
intra-procedural hemodynamics measured by amount of used vasopressors
total amount of sedatives
total amount of analgesics
duration of mechanical ventilation
duration of ICU stay

Full Information

First Posted
October 19, 2015
Last Updated
March 27, 2019
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT02588742
Brief Title
The Effect of Melatonin on Postoperative Delirium in Elderly ICU Patients
Official Title
The Effect of Melatonin on Postoperative Delirium in Elderly ICU Patients : Randomized, Placebo-controlled, Double Blind Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Why Stopped
Terminate the study because it is difficult to recruit the subject.
Study Start Date
February 2, 2015 (undefined)
Primary Completion Date
January 15, 2016 (Actual)
Study Completion Date
January 15, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium
Keywords
elderly ICU patients

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
melatonin group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Melatonin
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
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 Measure Information:
Title
incidence of delirium
Description
The score of ICD-SC(Intensive Care Delirium Screening Checklist) will be recorded to identify the incidence of delirium for 5 days after surgery.
Time Frame
5 days after surgery
Secondary Outcome Measure Information:
Title
change of amount of used vasopressors as a measure of intraoperative hemodynamics
Description
intra-procedural hemodynamics measured by amount of used vasopressors
Time Frame
up to 5 days
Title
total amount of sedatives
Time Frame
up to 5 days
Title
total amount of analgesics
Time Frame
up to 5 days
Title
duration of mechanical ventilation
Time Frame
up to 5 days
Title
duration of ICU stay
Time Frame
up to 5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of

12. IPD Sharing Statement

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The Effect of Melatonin on Postoperative Delirium in Elderly ICU Patients

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