Purpose of study: Determining the effect of remote Ischemic preconditioning in prevention of delirium in patients with coronary artery bypass graft.
Study design: Randomized, non-blind
Sample size: 80
Major inclusion criteria: candidates for elective cardiopulmonary bypass surgery; 55-70 years old patients؛ patients with EF greater than 35% (Severe LV dysfunction). Major exclusion criteria: Reexploration (Patients who return to operating room after heart surgery due to excessive bleeding)؛ embedded IABP (embedded balloon pump in the operating room or the ICU because of LV dysfunction؛ patients with acute MI (patients with myocardial infarction during previous week)؛ DM؛ history of stroke؛ upper extremity peripheral vascular problems؛ unwillingness to continue the participation, no initial consent؛ transfer to other medical centers؛ psychiatric drugs؛ history of psychiatric disorders such as psychosis, mental retardation؛ presence of ST changes during operation.
Intervention: a questionnaire (include the checklist for surveying psychological status of patient) is provided. The night before open heart surgery, delirium questionnaire will be filled. Then intervention method called remote preconditioning Ischemic will be used as follow: Remote preconditioning Ischemic will be applied after induction of anesthesia using a inflated blood pressure cuff, 9-12 cm wide, closed at the top of participants arm.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017041712830N21
Registration date:2017-06-29, 1396/04/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-29, 1396/04/08
Registrant information
Name
Faezeh Jahanpour
Name of organization / entity
Bushehr University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 77 1455 0187
Email address
f.jahanpour@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Bushehr University Of Medical Sciences
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of remote ischemic preconditioning in prevention of delirium in patient with cardiopulmonary bypass
Public title
The effect of remote ischemic preconditioning in prevention of delirium in patient with cardiopulmonary bypass
Purpose
Prevention
Inclusion/Exclusion criteria
Major inclusion criteria: candidates for elective cardiopulmonary bypass surgery; 55-70 years old patients؛ patients with EF greater than 35% (Severe LV dysfunction). Major exclusion criteria: Reexploration (Patients who return to operating room after heart surgery due to excessive bleeding)؛ embedded IABP (embedded balloon pump in the operating room or the ICU because of LV dysfunction؛ patients with acute MI (patients with myocardial infarction during previous week)؛ DM؛ history of stroke؛ upper extremity peripheral vascular problems؛ unwillingness to continue the participation, no initial consent؛ transfer to other medical centers؛ psychiatric drugs؛ history of psychiatric disorders such as psychosis, mental retardation؛ presence of ST changes during operation
Age
From 55 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Randomization by using Excel table
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Bushehr University of Medical Sciences
Street address
Bushehr University Of Medical Sciences, Next to the hospital Salman Farsi, Sabzabad,Bushehr
City
Bushehr
Postal code
Approval date
2017-03-13, 1395/12/23
Ethics committee reference number
IR.BPUMS.REC.1395.210
Health conditions studied
1
Description of health condition studied
delirium
ICD-10 code
F05
ICD-10 code description
Postoperative delirium
Primary outcomes
1
Description
Delirium
Timepoint
Before the intervention, one to five days after the intervention
Method of measurement
The checklist of delirium(NEECHAM)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: A checklist that investigates the psychological status of patients will be filled the night before open heart surgery. The occurrence of delirium is investigated by questionnaire from the night before surgery daily until 5 days after the operation. Assessing delirium will be done in 18-20 pm. The type, dosage and time of using medication (for example haloperidol if necessary) will also be recorded in the questionnaire. In remote ischemic preconditioning technique, an inflated blood pressure cuff, 9-12 cm wide, will be used after induction of anesthesia which will be closed at the top of participants’arm. Pressure of cuff is 200 mm Hg. Duration of use of inflated cuff is five minutes and after that cuff will be emptied in five minutes. The intervention will be done in three five-minute cycles and totally takes 30 minutes. During the anesthesia induction phase, medications such as Etomidate, which cannot induce remote preconditioning ischemic condition, will be used . After ECG, SPO2 and arterial line monitoring, induction of anesthesia starts. The method of anesthesia induction is considered by medications including Etomidate + Sufentanil+Midazolam. After intubating and placing CVP, patients are maintained by removal of inhaled medications Isoflurane and Sevoflurane and application of infusion of Sufentanil + Midazolam+ Atracurium. All patients receive 100% oxygen during anesthesia step. In anesthesia, patients candidate for open heart surgery require embedded arterial line (mostly from the left hand which induces no cardiovascular problems) and intravenous lines are inserted in the other hand. Cuff will be closed on another hand. All intravenous lines will be taken in the same hand with arterial lines. This intervention will be done under supervision of heart anesthesiologist.
Category
Prevention
2
Description
Control Group: In this group, alsothe questionnaire in the night before surgery and daily to 5 days after surgery would be filled. In this group, after induction of anesthetic, preconditioning Ischemic method wouldn’t be used. The method and the use of anesthetic drugs in this group is similar to intervention group.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Boshehr Heart Center hospital
Full name of responsible person
Dr Hajyoni
Street address
Boshehr Heart Center hospital, Crossroads of Justice, Sangi street
City
boshehr
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Bushehr University of Medical Sciences
Full name of responsible person
dr Afshin Ostovar
Street address
Bushehr University Of Medical Sciences
City
Bushehr
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 of Bushehr 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
Bushehr University of Medical Sciences
Full name of responsible person
Dr Faezeh Jahanpour
Position
PhD in nursing/ Faculty member
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Bushehr University of Medical Sciences
City
Bushehr
Postal code
Phone
+98 77 3332 8598
Fax
Email
f.jahanpour@bpums.ac.irfa_jahanpour@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Dr Faezeh Jahanpour
Position
PhD in nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Bushehr University of Medical Sciences
City
Bushehr
Postal code
Phone
+98 77 3332 8598
Fax
Email
f.jahanpour@bpums.ac.ir fa_jahanpour@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)