Association of Plasma Melatonin Levels With Delirium

Association of Plasma Melatonin Levels With Delirium After Sevoflurane Anesthesia

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).

Study Overview

• Status: Completed
• Conditions: Postoperative 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.

• Study Type: Observational
• Enrollment (Actual): 33

Contacts and Locations

Study Locations

• Japan
  • Okayama, Japan, 700-8525
    • Okayama University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Okayama University Hospital with 22 beds in ICU.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Delirium,Nondelirium; those with delirium and those without delirium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.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).	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.

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (ACTUAL): January 1, 2011
• Study Completion (ACTUAL): January 1, 2011

Study Registration Dates

• First Submitted: March 24, 2012
• First Submitted That Met QC Criteria: April 2, 2012
• First Posted (ESTIMATE): April 4, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): April 5, 2012
• Last Update Submitted That Met QC Criteria: April 3, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: melatonin; sevoflurane; postoperative delirium
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: Okamasui3130