Postoperative Melatonin Administration and Delirium Prevention in Patients Undergoing Vascular and Cardiac Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01198938
First received: September 8, 2010
Last updated: February 21, 2013
Last verified: February 2013

September 8, 2010
February 21, 2013
August 2010
February 2013   (final data collection date for primary outcome measure)
Incidence of postoperative delirium [ Time Frame: preoperative assessment up to 7 days postoperatively ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01198938 on ClinicalTrials.gov Archive Site
Pain score, using the standard 10-cm visual analog score (0-no pain, 10-worst, unbearable pain) [ Time Frame: Preoperative assessment upt to 7 days postoperatively ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Postoperative Melatonin Administration and Delirium Prevention in Patients Undergoing Vascular and Cardiac Surgery
Postoperative Melatonin Administration and Delirium Prevention in Patients Undergoing Vascular and Cardiac Surgery

The investigators plan to evaluate the effect of postoperative melatonin administration on postoperative delirium in patients undergoing vascular and cardiac surgery. A total of 302 patients older than 60, undergoing elective vascular surgery will be randomly divided into 2 groups: treatment and control. During the first 5 postoperative days patients will receive sublingually either melatonin 5 mg or placebo at 9:00 pm. The patients will be assessed for the signs of delirium, quality of sleep and severity of pain daily for the first postoperative week. Screening of delirium will be performed by the specially trained research assistant and based on the Confusion Assessment Method and the validated chart review. Diagnosis of delirium will be confirmed by the psychiatrist. Incidence of delirium will be compared between the groups.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Cardiac Surgery
Other: Melatonin
Melatonin 5 mg sublingually given at 9 p.m. for 5 postoperative days or until discharge
Active Comparator: Melatonin
Intervention: Other: Melatonin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
February 2013
February 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Non-emergent vascular surgery, with an expected length of stay ≥ 48hours, ASA categories I to IV, signed informed consent, age >60

Exclusion Criteria:

  • Lack of informed consent, ASA category V, history of psychiatric illness (schizophrenia, psychosis, bipolar disorder, major depression), Mini Mental State Examination score (MMSE) ≤ 24, history of autoimmune disease, liver cirrhosis, minimally invasive procedures (endovascular aneurysm repair ), history of chronic insomnia, chronic benzodiazepines and/or hypnotics use ( > 3 times /week during a month prior to surgery), treatment with tricyclic antidepressants within a month prior to surgery, history of seizures, allergy to placebo ingredients or melatonin ( WN Pharmaceuticals.LTD), melatonin consumption in the last months prior to surgery.
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01198938
UHN090334B
No
University Health Network, Toronto
University Health Network, Toronto
Not Provided
Principal Investigator: Rita Katznelson, MD Toronto General Hospital, UHn
University Health Network, Toronto
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP