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

Primary Purpose

Cardiac Surgery

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Melatonin
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiac Surgery focused on measuring Cardiac surgery, delirium, melatonin

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Toronto General Hospital, UHN

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Melatonin

Arm Description

Outcomes

Primary Outcome Measures

Incidence of postoperative delirium

Secondary Outcome Measures

Pain score, using the standard 10-cm visual analog score (0-no pain, 10-worst, unbearable pain)

Full Information

First Posted
September 8, 2010
Last Updated
February 21, 2013
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT01198938
Brief Title
Postoperative Melatonin Administration and Delirium Prevention in Patients Undergoing Vascular and Cardiac Surgery
Official Title
Postoperative Melatonin Administration and Delirium Prevention in Patients Undergoing Vascular and Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Surgery
Keywords
Cardiac surgery, delirium, melatonin

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Melatonin
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Melatonin
Intervention Description
Melatonin 5 mg sublingually given at 9 p.m. for 5 postoperative days or until discharge
Primary Outcome Measure Information:
Title
Incidence of postoperative delirium
Time Frame
preoperative assessment up to 7 days postoperatively
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rita Katznelson, MD
Organizational Affiliation
Toronto General Hospital, UHn
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto General Hospital, UHN
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada

12. IPD Sharing Statement

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

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