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The Effect of Melatonin on Postoperative Delirium in Elderly ICU Patients

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ClinicalTrials.gov Identifier: NCT02588742
Recruitment Status : Unknown
Verified October 2015 by Yonsei University.
Recruitment status was:  Not yet recruiting
First Posted : October 28, 2015
Last Update Posted : October 28, 2015
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Delirium Dietary Supplement: Melatonin Dietary Supplement: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Melatonin on Postoperative Delirium in Elderly ICU Patients : Randomized, Placebo-controlled, Double Blind Study
Study Start Date : October 2015
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium
Drug Information available for: Melatonin

Arm Intervention/treatment
Experimental: melatonin group
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.
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 Comparator: control group
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.
Dietary Supplement: 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 :
  1. incidence of delirium [ Time Frame: 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 :
  1. change of amount of used vasopressors as a measure of intraoperative hemodynamics [ Time Frame: up to 5 days ]
    intra-procedural hemodynamics measured by amount of used vasopressors

  2. total amount of sedatives [ Time Frame: up to 5 days ]
  3. total amount of analgesics [ Time Frame: up to 5 days ]
  4. duration of mechanical ventilation [ Time Frame: up to 5 days ]
  5. duration of ICU stay [ Time Frame: up to 5 days ]


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02588742


Locations
Korea, Republic of
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine Not yet recruiting
Seoul, Korea, Republic of, 120-752
Contact: Sungwon Na, MD    82-2-2228-2420    nswksj@yuhs.ac   
Sponsors and Collaborators
Yonsei University

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02588742     History of Changes
Other Study ID Numbers: 4-2014-1038
First Posted: October 28, 2015    Key Record Dates
Last Update Posted: October 28, 2015
Last Verified: October 2015

Keywords provided by Yonsei University:
elderly ICU patients

Additional relevant MeSH terms:
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants