NCT02588742

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 28, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2016

Completed
Last Updated

March 29, 2019

Status Verified

February 1, 2019

Enrollment Period

12 months

First QC Date

October 19, 2015

Last Update Submit

March 27, 2019

Conditions

Delirium

Keywords

elderly ICU patients

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • change of amount of used vasopressors as a measure of intraoperative hemodynamics

    up to 5 days

  • 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

Study Arms (2)

melatonin group

EXPERIMENTAL

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

control group

PLACEBO COMPARATOR

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

Interventions

MelatoninDIETARY_SUPPLEMENT

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.

melatonin group
PlaceboDIETARY_SUPPLEMENT

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.

control group

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Delirium

Interventions

Melatonin

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2015

First Posted

October 28, 2015

Study Start

February 2, 2015

Primary Completion

January 15, 2016

Study Completion

January 15, 2016

Last Updated

March 29, 2019

Record last verified: 2019-02

Locations

KR(1)