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Treatment With Benzodiazepine After Cardiac Surgery

NCT02776228 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2016-11-10

No results posted yet for this study

Summary

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • Rambam Health Care Campus

    lead OTHER

Principal Investigators

  • gil mr bolotin, MD · Rambam Health Care Campus

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2017-04-30
Completion
2018-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02776228 on ClinicalTrials.gov