Treatment With Benzodiazepine After Cardiac Surgery

NCT02776228 | Unknown Phase 3

• 1 other identifier: cs 001-16
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Insomnia

Outcome Measures

Primary Outcomes (1)

• Assessing chronic insomnia

  The following outcome will be evaluated by Pittsburgh sleep quality index questionnaire before heart surgery.

  1 year

Secondary Outcomes (1)

• Reducing insomnia in post cardiac surgery

  1 year

Study Arms (2)

benzodiazepine

EXPERIMENTAL

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

placebo

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

Brotizolam DRUG

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.

Also known as: Lendormin

benzodiazepine

placebo DRUG

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.

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 and older.
• Applicants hospital for open heart surgery

You may not qualify if:

• patients who came to emergency heart surgery.
• patients who are not hemodynamically or respiratory stable
• Patients who were taking hypnotic drugs on a daily basis before surgery.
• Patients with low compliance that will not be able to fill out a sleep diary
• lactose intolerance (due to components placebo)
• 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.

Sponsors & Collaborators

• Rambam Health Care Campus: lead

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

brotizolam

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• gil mr bolotin, MD

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

tom mr fridman, MD

CONTACT

0542220892; tomalach@gmail.com

daniel ms haber, MA

CONTACT

0526138901; d_haber@rambam.health.gov.il

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2016
• First Posted: May 18, 2016
• Study Start: December 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2018
• Last Updated: November 10, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share