Treatment With Benzodiazepine After Cardiac Surgery

Phase 3

• Conditions: Insomnia
• Interventions: Drug: placebo; Drug: Brotizolam

• Registration Number: NCT02776228
• Lead Sponsor: Rambam Health Care Campus

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2016-03-23
• Study First Submitted QC: 2016-05-16
• Study First Posted: 2016-05-18
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-09
• Last Update Posted: 2016-11-10
• Study Start: 2016-12
• Primary Completion: 2017-04
• Study Completion: 2018-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Age 18 and older.
2. Applicants hospital for open heart surgery

Exclusion Criteria

1. patients who came to emergency heart surgery.

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	The patient which will be in the placebo arm (after randomization) will receive placebo for six weeks from the day of discharge.
benzodiazepine	Brotizolam	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.

Primary Outcome Measures

Name	Time	Method
Assessing chronic insomnia	1 year	The following outcome will be evaluated by Pittsburgh sleep quality index questionnaire before heart surgery.

Secondary Outcome Measures

Name	Time	Method
Reducing insomnia in post cardiac surgery	1 year	The following outcome will be evaluated by Pittsburgh sleep quality index questionnaire after heart surgery.