Association of Plasma Melatonin Levels With Delirium

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shiho Yoshitaka, Okayama University
ClinicalTrials.gov Identifier:
NCT01570881
First received: March 24, 2012
Last updated: April 3, 2012
Last verified: April 2012
  Purpose

Delirium is common complications in postoperative critically ill patients. However the mechanism of postoperative delirium is not well understood.The investigators designed a prospective observational study to investigate the association of perioperative plasma melatonin levels with postoperative delirium and general anesthesia. The investigators included 33 patients required intensive care more than 48 hours after sevoflurane anesthesia in an academic tertiary care hospital. The investigators measured plasma melatonin levels 4 times and assessed postoperative delirium using Confusion Assessment Method for the intensive care unit (CAM-ICU).


Condition
Postoperative Delirium

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Association of Plasma Melatonin Levels With Delirium After Sevoflurane Anesthesia

Resource links provided by NLM:


Further study details as provided by Okayama University:

Primary Outcome Measures:
  • The diagnose of postoperative delirium [ Time Frame: One trained physician performed assessments of delirium at 1 hour after operation, and 8 AM and 5 PM of postoperative day 1 and 2. ] [ Designated as safety issue: Yes ]
    One trained physician performed assessments of delirium using Confusion Assessment Method for the intensive care unit at 1 hour after operation, and 8 AM and 5 PM of postoperative day 1 and 2.


Secondary Outcome Measures:
  • The measurements of plasma melatonin levels [ Time Frame: We collected blood samples for the measurement of plasma melatonin levels at 1) 8 AM before operation, 2) 1 hour after operation, 3) 8 AM of postoperative day 1 and 4) 8 AM of postoperative day 2. ] [ Designated as safety issue: Yes ]
    We collected blood samples for the measurement of plasma melatonin levels at 1) 8 AM before operation, 2) 1 hour after operation, 3) 8 AM of postoperative day 1 and 4) 8 AM of postoperative day 2.Plasma was separated by centrifugation and the plasma was stored at least -30 degrees Celsius in a polypropylene tube until the time of assay. Plasma melatonin levels were measured with a melatonin radioimmunoassay kit (Buhlmann Laboratories AG, Allschwil, Switzerland).


Enrollment: 33
Study Start Date: April 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Delirium,Nondelirium
those with delirium and those without delirium

Detailed Description:

Delirium is common complications in postoperative critically ill patients. Although the mechanism of postoperative delirium is not well understood, there are several studies to report alternation of plasma melatonin levels after general anesthesia and suggest the link between delirium and abnormal tryptophan-serotonin-melatonin metabolism. However, there are few studies to assess the association of perioperative plasma melatonin levels with postoperative delirium and/or general anesthetics.

The investigators designed a prospective observational study to investigate the association of perioperative plasma melatonin levels with postoperative delirium and general anesthesia. The investigators included 33 patients required intensive care more than 48 hours after sevoflurane anesthesia in an academic tertiary care hospital. The investigators measured plasma melatonin levels and assessed postoperative delirium using Confusion Assessment Method for the intensive care unit (CAM-ICU). The investigators compared perioperative plasma melatonin levels between patients with and without delirium, and assessed associations of patients' demographics and anesthesia with plasma melatonin levels.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Okayama University Hospital with 22 beds in ICU.

Criteria

Inclusion Criteria:

  • patients over 20 years of age who had undergone elective surgery with sevoflurane anesthesia and were expected to require postoperative intensive care for more than 48 hours

Exclusion Criteria:

  • emergency surgery, history of psychosis and drug/alcohol abuse, and vision or hearing impairment
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01570881

Locations
Japan
Okayama University
Okayama, Japan, 700-8525
Sponsors and Collaborators
Okayama University
Investigators
Principal Investigator: Moritoki Egi Department of Anesthesiology and Resuscitology, Okayama University
  More Information

No publications provided by Okayama University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shiho Yoshitaka, M.D., Okayama University
ClinicalTrials.gov Identifier: NCT01570881     History of Changes
Other Study ID Numbers: Okamasui3130
Study First Received: March 24, 2012
Last Updated: April 3, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Okayama University:
postoperative delirium
melatonin
sevoflurane

Additional relevant MeSH terms:
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014