Treatment With Benzodiazepine After Cardiac Surgery

The Influence of Short Term Treatment With Benzodiazepine After Cardiac Surgery

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

Study Overview

• Status: Unknown
• Conditions: Insomnia
• Intervention / Treatment: Drug: Brotizolam; Drug: placebo

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: tom mr fridman, MD; Phone Number: 0542220892; Email: tomalach@gmail.com
• Study Contact Backup: Name: daniel ms haber, MA; Phone Number: 0526138901; Email: d_haber@rambam.health.gov.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.; Other Names: Lendormin
Placebo Comparator: placebo; The patient which will be in the placebo arm (after randomization) will receive placebo for six weeks from the day of discharge.	Drug: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus
• Investigators: Principal Investigator: gil mr bolotin, MD, Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Anticipated): April 1, 2017
• Study Completion (Anticipated): April 1, 2018

Study Registration Dates

• First Submitted: March 23, 2016
• First Submitted That Met QC Criteria: May 16, 2016
• First Posted (Estimate): May 18, 2016

Study Record Updates

• Last Update Posted (Estimate): November 10, 2016
• Last Update Submitted That Met QC Criteria: November 9, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Hypnotics and Sedatives; Brotizolam
• Other Study ID Numbers: cs 001-16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes