Postoperative Melatonin Administration and Delirium Prevention in Patients Undergoing Vascular and Cardiac Surgery
This study has been completed.
Sponsor:
University Health Network, Toronto
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
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Cardiac Surgery |
Other: Melatonin |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Postoperative Melatonin Administration and Delirium Prevention in Patients Undergoing Vascular and Cardiac Surgery |
Resource links provided by NLM:
Further study details as provided by University Health Network, Toronto:
Primary Outcome Measures:
- Incidence of postoperative delirium [ Time Frame: preoperative assessment up to 7 days postoperatively ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 100 |
| Study Start Date: | August 2010 |
| Study Completion Date: | February 2013 |
| Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Melatonin |
Other: Melatonin
Melatonin 5 mg sublingually given at 9 p.m. for 5 postoperative days or until discharge
|
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01198938
Locations
| Canada, Ontario | |
| Toronto General Hospital, UHN | |
| Toronto, Ontario, Canada, M5G 2C4 | |
Sponsors and Collaborators
University Health Network, Toronto
Investigators
| Principal Investigator: | Rita Katznelson, MD | Toronto General Hospital, UHn |
More Information
No publications provided
| Responsible Party: | University Health Network, Toronto |
| ClinicalTrials.gov Identifier: | NCT01198938 History of Changes |
| Other Study ID Numbers: | UHN090334B |
| Study First Received: | September 8, 2010 |
| Last Updated: | February 21, 2013 |
| Health Authority: | Canada: Ethics Review Committee Canada: Health Canada |
Keywords provided by University Health Network, Toronto:
|
Cardiac surgery, delirium, melatonin |
Additional relevant MeSH terms:
|
Delirium Confusion Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Melatonin |
Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents |
ClinicalTrials.gov processed this record on May 19, 2013