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Association of Plasma Melatonin Levels With Delirium

Sponsor
Okayama University (Other)
Overall Status
Completed
CT.gov ID
NCT01570881
Collaborator
(none)
33
Enrollment
1
Location
9
Duration (Months)
3.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    33 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Association of Plasma Melatonin Levels With Delirium After Sevoflurane Anesthesia
    Study Start Date :
    Apr 1, 2010
    Actual Primary Completion Date :
    Jan 1, 2011
    Actual Study Completion Date :
    Jan 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    Delirium,Nondelirium

    those with delirium and those without delirium

    Outcome Measures

    Primary Outcome Measures

    1. The diagnose of postoperative delirium [One trained physician performed assessments of delirium at 1 hour after operation, and 8 AM and 5 PM of postoperative day 1 and 2.]

      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

    1. The measurements of plasma melatonin levels [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.]

      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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Okayama University Okayama Japan 700-8525

    Sponsors and Collaborators

    • Okayama University

    Investigators

    • Principal Investigator: Moritoki Egi, Department of Anesthesiology and Resuscitology, Okayama University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shiho Yoshitaka, M.D., Okayama University
    ClinicalTrials.gov Identifier:
    NCT01570881
    Other Study ID Numbers:
    • Okamasui3130
    First Posted:
    Apr 4, 2012
    Last Update Posted:
    Apr 5, 2012
    Last Verified:
    Apr 1, 2012
    Keywords provided by Shiho Yoshitaka, M.D., Okayama University
    postoperative delirium
    melatonin
    sevoflurane
    Additional relevant MeSH terms:
    Delirium

    Study Results

    No Results Posted as of Apr 5, 2012