Treatment With Benzodiazepine After Cardiac Surgery

Study Overview
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Brief Summary
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The study deals with the prevalence of insomnia after heart surgery and the outcome of treatment with Benzodiazepine for this phenomena.

Detailed Description
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Patients after heart surgery develop sleep disorder in the form of Insomnia. This finding is known and described in the literature with respect to a large number of major operations such as the pneumonectomy, esophageal resection, pancreatic surgery, liver surgery and so on. In the general population, Insomnia is a common disorder and describe in more than 50% in adults over the age of 50. In patients with comorbidity among other things, heart disease indicates a rate of up to 85% of chronic insomnia. The reasons for insomnia after multiple heart surgery, including emotional stress that accompanies the patient after surgery, pain and prolonged hospitalization in the hospital. In this study, aim to compare the results of short-term treatment with sleep medication after heart surgery on morbidity and immediate recovery. This study will allow us to examine the effect of sleep medication therapy in patients receiving treatment compared to patients who did not receive treatment.

Official Title
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The Influence of Short Term Treatment With Benzodiazepine After Cardiac Surgery

Conditions
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Insomnia

Intervention / Treatment
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* Drug: Brotizolam
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 and older. Applicants hospital for open heart surgery Exclusion Criteria: patients who came to emergency heart surgery. patients who are not hemodynamically or respiratory stable Patients who were taking hypnotic drugs on a daily basis before surgery. Patients with low compliance that will not be able to fill out a sleep diary lactose intolerance (due to components placebo) Patients who can not take medication by one or more of the following: pregnant. nursing. Patients with severe respiratory insufficiency Patients with liver failure. Patients who are addicted to alcohol Patients without psychiatric background.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: benzodiazepine<br>The patient which will be in the Experimental arm (after randomization) will receive 0.25 mg of Brotizolam (short acting benzodiazepine) for six weeks from the day of discharge. | Drug: Brotizolam<br>* Every patient which will enroll to the study will fill up The Pittsburgh Sleep Quality Index in there admission to the cardiac surgery unit. in the discharge day the patient will receive 0.25 mg brotizolam once a day before sleep for six weeks. one week and six weeks after discharge day, there is routine follow up in our outpatient clinic. in those appointed time the patient will fill again The Pittsburgh Sleep Quality Index.<br>* Other names: Lendormin;|
| Placebo Comparator: placebo<br>The patient which will be in the placebo arm (after randomization) will receive placebo for six weeks from the day of discharge. | Drug: placebo<br>* Every patient which will enroll to the study will fill up The Pittsburgh Sleep Quality Index in there admission to the cardiac surgery unit. in the discharge day the patient will receive 0.25 mg LACTOSE once a day before sleep for six weeks. one week and six weeks after discharge day, there is routine follow up in our outpatient clinic. in those appointed time the patient will fill again The Pittsburgh Sleep Quality Index.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing chronic insomnia | The following outcome will be evaluated by Pittsburgh sleep quality index questionnaire before heart surgery. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reducing insomnia in post cardiac surgery | The following outcome will be evaluated by Pittsburgh sleep quality index questionnaire after heart surgery. | 1 year |