Clinical trial NCT01570881: Association of Plasma Melatonin Levels With Delirium
Official title: Association of Plasma Melatonin Levels With Delirium After Sevoflurane Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Delirium
Keywords: postoperative delirium
melatonin
sevoflurane
Lead sponsor: Okayama University
Sponsor class: OTHER
First posted: 2012-04-04
Enrollment: 33
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Okayama University Hospital with 22 beds in ICU.

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).

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 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

Primary outcomes:
measure: The diagnose of postoperative delirium
timeFrame: 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:
measure: The measurements of plasma melatonin levels
timeFrame: 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.
Other outcomes:
Locations:
city: Okayama
country: Japan
facility: Okayama University
Study officials:
affiliation: Department of Anesthesiology and Resuscitology, Okayama University
name: Moritoki Egi
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.