NCT02776228

Treatment With Benzodiazepine After Cardiac Surgery

The Influence of Short Term Treatment With Benzodiazepine After Cardiac Surgery

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Rambam Health Care Campus · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Insomnia

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2016-12-01
• Primary completion: 2017-04-01
• Completion: 2018-04-01
• First posted: 2016-05-18
• Last updated: 2016-11-10