Association of Plasma Melatonin Levels With Delirium

Postoperative Delirium Clinical Trial

Official title:

Association of Plasma Melatonin Levels With Delirium After Sevoflurane Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01570881
• Other study ID #: Okamasui3130
• Status: Completed
• Phase: N/A
• First received: March 24, 2012
• Last updated: April 3, 2012
• Start date: April 2010
• Est. completion date: January 2011

Study information

• Verified date: April 2012
• Source: Okayama University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Delirium
• Postoperative Delirium

Locations

Country	Name	City	State
Japan	Okayama University	Okayama

Sponsors (1)

Lead Sponsor	Collaborator
Okayama University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	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.	Yes