Protocol summary

Summary
This study after clinical trials confirm the Shahid rajaei Heart Hospital Ethics Committee and head of the relevant sections of satisfaction. two parts simple and random ICUB and ICUA for sampling patients group and intervention( A) group are specified control( B). Using the results of a similar article (2013Maryam Mirzaie) sample size per group of 51 people. Open heart surgery is 110 people nominated to enter according to the inclusion criteria can be included and of all written consent. clinic a few days before patients by basic business information and anesthesiologist and demographic them in the form before registration. All patients in the operating room of a protocol will be entitled to the same anesthesia. For all patients to cpb connection time, duration, duration of anesthesia, aorta clamps the duration of the action in the action during the registration form. In the control group (ICUB) from the beginning of the entry of patients into the next section of the action are attached to the surface until the ventilator , according to the previous hospital routine, based on the criterion of the hemodynamic parameters and Glasgowcoma index to be measured and recorded by mental nurse. sedation level in the intervention group with the use of the CIS Any two spectral index measured for some themes and can be recorded. In both groups of medicinal drugs contain almost the same protocol to the PCA pump, persedex, Midazolam, morphine, ketrolac, apotel . For both groups in postoperative chart the amount of incoming mechanical ventilation, duration of sedating, duration of ICU stay duration of hospital admission record. then the data were analyzed by SPSS 22 case analysis.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016061428467N1
Registration date: 2017-11-01, 1396/08/10
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-11-01, 1396/08/10
Registrant information
Name
Elnaz Boorghani Farahani
Name of organization / entity
Shahid Rajayi Heart Center
Country
Iran (Islamic Republic of)
Phone
+98 21 23921
Email address
elnaz.farahani@rhc.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Rajayi Heart Hospital
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of use of Bispecteral index monitoring on outcomes of undergoing mechanical ventilation hospitalized patients in intensive care units after open heart surgeries
Public title
Assessment of clinical implication of bispectral index system in patient sedation
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:age range between 30 to 75 years, deduction equal 30 percent more a drain lip; the lack of a history of cerebrovascular accidents; lack of addiction to alcohol and drugs; fully under the emergency open heart surgery is not time equal less than 100 minutes aorta clamps; Cardiopulmonary bypass time less than equal to 120 minutes; during the action need to be inside the pump the aorta balloons placement; the duration of anesthesia equal less than 10 hours; total eclipses between 1-4 and without anderecthomy The exclusion criteria of the study:the patients after surgery following complications suffered are not: Myocardial infarction; cerebral and neurological complications; clotting problems; surgery; cardiac output reduction syndrome; a dangerous arrhythmias require resuscitation; pnemothorax; renal failer mechanical ventilation more than 12 hours after admission to the ICU, the trachea inside the tubing need to reset, the duration of the surgical time over 8 hours, need to re-surgery, bleeding more than 100 cc in the hours after the withdrawal of the patient from the operating room, the instability of hemodynamic status, cardiopulmonary resuscitation, the death of the patient
Age
From 30 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 110
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shahid Rajayi Heart Center
Street address
Mellat park beside, Valiasr st, Tehran
City
Tehran
Postal code
1995614331
Approval date
2017-04-21, 1396/02/01
Ethics committee reference number
RHC.AC.TR.REC.1396.19

Health conditions studied

1

Description of health condition studied
ventilated patient in icu after open heart surgery
ICD-10 code
IX120-121-
ICD-10 code description
بیماریهای ایسکمیک قلبی

Primary outcomes

1

Description
measure of sedative drug dosage
Timepoint
while intervention
Method of measurement
bispectral index system

Secondary outcomes

1

Description
ventilation duration
Timepoint
of patient enterance to icu until extubation
Method of measurement
observation and record

Intervention groups

1

Description
" Control group: post operation icu addmition ; sedatin control according to the previous routine by nurse; Persedex PCA, midazolam, morphin, apotel, ketrolac administering according the protochol and nursing decision; consuming drug record; extubation time record; icu stay and hospital stay record."
Category
Treatment - Other

2

Description
"intervention group: post operation icu addmission; connect ing bispectral index system to pateint from arrival time to extubation time and sedation score record per 2 hours; drug administerating according bis score and the protochol; consuming drug record; extubation time record; icu stay and hospital stay record. "
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Rajayi Hospital
Full name of responsible person
Elnaz Boorghni Farahani
Street address
Mellat Park beside, Valiasr st, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research Shahid Rajayi Heart Center
Full name of responsible person
Mr Dr Mostafa Alavi
Street address
Mellat Park beside, Valiasr st, Tehran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research Shahid Rajayi Heart Center
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Rajayi Heart Center
Full name of responsible person
Elnaz Boorghni Farahani
Position
Critical Care Master student of Shahid Rajayi Center
Other areas of specialty/work
Street address
Mellat Park beside, Valiasr st, Tehran
City
Tehran
Postal code
1995614331
Phone
+98 21 23921
Fax
+98 21 2204 2026
Email
elnaz.frhn@gmail.com
Web page address
www.rhc.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Rajayi Heart Center
Full name of responsible person
Elnaz Boorghani Farahani
Position
Critical care Nursing master student
Other areas of specialty/work
Street address
Mellat Park beside, Valiasr st, Tehran
City
Tehran
Postal code
1995614331
Phone
+98 21 23921
Fax
+98 21 2204 2026
Email
elnaz.farahani@rhc.ac.ir
Web page address
www.rhc.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Rajayi Heart Center
Full name of responsible person
Elnaz Boorghani fFarahani
Position
Critical Care Nursing Master Student of Shahid Rajayi Center
Other areas of specialty/work
Street address
Mellat Park
City
Tehran
Postal code
1995614331
Phone
+98 21 23921
Fax
+98 21 2204 2026
Email
elnaz.frhn@rhc.ac.ir
Web page address
www.rhc.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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