Treatment With Benzodiazepine After Cardiac Surgery

Insomnia Clinical Trial

Official title:

The Influence of Short Term Treatment With Benzodiazepine After Cardiac Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02776228
• Other study ID #: cs 001-16
• Status: Not yet recruiting
• Phase: Phase 3
• First received: March 23, 2016
• Last updated: November 9, 2016
• Start date: December 2016
• Est. completion date: April 2018

Study information

• Verified date: November 2016
• Source: Rambam Health Care Campus
• Contact: tom mr fridman, MD
• Phone: 0542220892
• Email: tomalach[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: April 2018
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Insomnia

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessing chronic insomnia	The following outcome will be evaluated by Pittsburgh sleep quality index questionnaire before heart surgery.	1 year	No
Secondary	Reducing insomnia in post cardiac surgery	The following outcome will be evaluated by Pittsburgh sleep quality index questionnaire after heart surgery.	1 year	No