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The effect of Riker Sedation-Agitation scale on clinical outcomes in patients undergoing coronary artery bypass graft surgery in Imam Ali Hospital

Protocol summary

Summary
Objective: to determine the effect of Riker Sedation-Agitation scale on clinical outcomes in patients undergoing coronary artery bypass graft surgery in Imam Ali hospital, Kermanshah, Iran.Study design: Randomized. Study population: Patients undergoing open heart surgery and admitted to the intensive care unit at Imam Ali hospital. Major inclusion criteria: having an endotracheal tube, being under mechanical ventilation, having acceptable clinical and para clinical criteria such as left ventricular ejection fraction greater than 30% and lack history of cerebrovascular accident. Major exclusion criteria: mechanical ventilation for more than 24 hours, need to reintubation, length of operation time more than 4 hours, requiring reoperation. Sample Size:116 patients. Intervention: each hour in the intervention group, the patients were evaluated using Riker scale and based on patients receiving sedative medication and in the control group, based on the physiological criteria, medicine was given. Intervention time: The patient's arrival to the intensive care unit until extubation. Primary outcomes: sedative usage, length of mechanical ventilation and lengh of stay in intensive care unit and hospital, delirium incidence.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201209244736N4
Registration date: 2012-11-28, 1391/09/08
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-11-28, 1391/09/08
Registrant information
Name
Alireza Khatony
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3827 9394
Email address
akhatony@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research & technology, Kermanshah university of medical sciences
Expected recruitment start date
2012-11-21, 1391/09/01
Expected recruitment end date
2013-02-18, 1391/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Riker Sedation-Agitation scale on clinical outcomes in patients undergoing coronary artery bypass graft surgery in Imam Ali Hospital
Public title
The effect of Riker sedation-agitation scale on clinical outcomes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 1. Having coronary artery bypass graft surgery. 2. Having acceptable clinical and paraclinical criteria such as adequate tissue perfusion. 3. Age between 40-70 years old. 4. Lack of visual and listening problems. 5. Left ventricular ejection fraction more than 30%, 5. lack of cerebrovascular accidents. 6. Number of grafts between 1-4 without endarterectomy. Exclusion critera: 1. If the patient suffering from one of these disease after surgery: MI, CVA, coagulopathy, reoperation, dangerous arrhythmia, renal failure, wound infection, mechanical ventilation more than 24hour, need to reintubation, operation time more than 4 hour.
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 116
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
Kermanshah university of medical sciences
Street address
sepah pasdaran sq. shahid beheshty bld.
City
Kermanshah
Postal code
Approval date
2012-10-23, 1391/08/02
Ethics committee reference number
33970

Health conditions studied

1

Description of health condition studied
clinical outcomes
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
ventilation duration
Timepoint
after extubation
Method of measurement
measurment of ventilation time

2

Description
opium consumption dose
Timepoint
after extubation
Method of measurement
Recorded data of checklist during the intervention

Secondary outcomes

1

Description
delirium incidence
Timepoint
during stay in ICU
Method of measurement
delirium screening checklist in intansive care units

2

Description
lenght of stay in hospital
Timepoint
after discharge from hospital
Method of measurement
time of entry and exit from hospital

3

Description
lenght of stay in ICU
Timepoint
after discharge from ICU
Method of measurement
Based on the time of entry and exit

Intervention groups

1

Description
In this study in intervention group,the researcher assess the sedation and agitation level of patients with Riker scale. optimal level of Riker scale is 3,4 score
Category
Prevention

2

Description
In control group is used from routin method. This method is based on the physiologic and behavioral criteria such as vital signs and first awakening.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Ali hospital
Full name of responsible person
Dr Gholamreza Morady
Street address
Sepah pasdaran sq. shahid beheshty bld.
City
Kermanshah

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah university of medical sciences
Full name of responsible person
Dr Farid Najafy
Street address
Kermanshah university of medical sciences, sepah pasdaran sq. shahid beheshty bld.
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah university of medical sciences
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
school of paramedical science
Full name of responsible person
Reza pourmirza Kalhori
Position
MSc, faculty member
Other areas of specialty/work
Street address
Doolat abbad, ashayer bld.
City
Kermanshah
Postal code
6719851351
Phone
+98 83 1827 9899
Fax
+98 83 1827 9394
Email
rpourmirza@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
school of paramedical science
Full name of responsible person
Reza Pourmirza Kalhori
Position
MSc of nursing/ faculty member
Other areas of specialty/work
Street address
Doolat aba'd, ashayer bld.
City
Kermanshah
Postal code
6719851351
Phone
+98 83 1827 9899
Fax
+98 83 1827 9394
Email
rpourmirza@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah school of nursing and midwifery
Full name of responsible person
Alireza khatony
Position
PhD-faculty member
Other areas of specialty/work
Street address
Doolat aba'd, ashayer bld.
City
Kermanshah
Postal code
6719851351
Phone
+98 83 1827 9394
Fax
+98 83 1827 9394
Email
akhatony@gmail.com
Web page address
http://nursing-school.kums.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
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