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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2013-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Cardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Melatonin

Group Type ACTIVE_COMPARATOR

Melatonin

Intervention Type OTHER

Melatonin 5 mg sublingually given at 9 p.m. for 5 postoperative days or until discharge

Interventions

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Melatonin

Melatonin 5 mg sublingually given at 9 p.m. for 5 postoperative days or until discharge

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No