Association of Plasma Melatonin Levels With Delirium

NCT01570881 | Completed

• 1 other identifier: Okamasui3130
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

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).

Conditions

Postoperative Delirium

Keywords

postoperative delirium; melatonin; sevoflurane

Outcome Measures

Primary Outcomes (1)

• The diagnose of postoperative delirium

  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.

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

Secondary Outcomes (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.

Study Arms (1)

Delirium,Nondelirium

those with delirium and those without delirium

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Okayama University Hospital with 22 beds in ICU.

You may qualify if:

• 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

You may not qualify if:

• emergency surgery, history of psychosis and drug/alcohol abuse, and vision or hearing impairment

Sponsors & Collaborators

• Okayama University: lead

Study Sites (1)

Okayama University

Okayama, Okayama-ken, 700-8525, Japan

Location

Related Publications (1)

• Yoshitaka S, Egi M, Morimatsu H, Kanazawa T, Toda Y, Morita K. Perioperative plasma melatonin concentration in postoperative critically ill patients: its association with delirium. J Crit Care. 2013 Jun;28(3):236-42. doi: 10.1016/j.jcrc.2012.11.004. Epub 2013 Jan 9.

  PMID: 23312124 DERIVED

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Moritoki Egi

  Department of Anesthesiology and Resuscitology, Okayama University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: March 24, 2012
• First Posted: April 4, 2012
• Study Start: April 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: April 5, 2012

Record last verified: 2012-04

Locations

JP (1)