Study Results
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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UNKNOWN
PHASE3
200 participants
INTERVENTIONAL
2016-12-31
2018-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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benzodiazepine
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.
Brotizolam
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.
placebo
The patient which will be in the placebo arm (after randomization) will receive placebo for six weeks from the day of discharge.
placebo
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.
Interventions
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Brotizolam
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.
placebo
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Applicants hospital for open heart surgery
Exclusion Criteria
2. patients who are not hemodynamically or respiratory stable
3. Patients who were taking hypnotic drugs on a daily basis before surgery.
4. Patients with low compliance that will not be able to fill out a sleep diary
5. lactose intolerance (due to components placebo)
6. 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.
18 Years
ALL
No
Sponsors
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Rambam Health Care Campus
OTHER
Responsible Party
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Principal Investigators
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gil mr bolotin, MD
Role: PRINCIPAL_INVESTIGATOR
Rambam Health Care Campus
Central Contacts
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Other Identifiers
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cs 001-16
Identifier Type: -
Identifier Source: org_study_id