Association of Plasma Melatonin Levels With Delirium
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 |
|---|
|
Postoperative Delirium |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Association of Plasma Melatonin Levels With Delirium After Sevoflurane Anesthesia |
- The diagnose of postoperative delirium [ Time Frame: One trained physician performed assessments of delirium at 1 hour after operation, and 8 AM and 5 PM of postoperative day 1 and 2. ] [ Designated as safety issue: Yes ]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.
- The measurements of plasma melatonin levels [ Time Frame: 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. ] [ Designated as safety issue: Yes ]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).
| Enrollment: | 33 |
| Study Start Date: | April 2010 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Delirium,Nondelirium
those with delirium and those without 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.
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Okayama University Hospital with 22 beds in ICU.
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| Japan | |
| Okayama University | |
| Okayama, Japan, 700-8525 | |
| Principal Investigator: | Moritoki Egi | Department of Anesthesiology and Resuscitology, Okayama University |
More Information
No publications provided
| Responsible Party: | Shiho Yoshitaka, M.D., Okayama University |
| ClinicalTrials.gov Identifier: | NCT01570881 History of Changes |
| Other Study ID Numbers: | Okamasui3130 |
| Study First Received: | March 24, 2012 |
| Last Updated: | April 3, 2012 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Okayama University:
|
postoperative delirium melatonin sevoflurane |
Additional relevant MeSH terms:
|
Delirium Confusion Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Melatonin Sevoflurane Central Nervous System Depressants Physiological Effects of Drugs |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Platelet Aggregation Inhibitors Hematologic Agents Anesthetics, Inhalation Anesthetics, General Anesthetics |
ClinicalTrials.gov processed this record on May 23, 2013