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The Impact of Postoperative Dexmedetomidine on Outcomes of Orally Addicted Patients Undergoing Off Pump Coronary Artery Bypass Grafting

Protocol summary

Study aim
Today, there are many drugs to reduce pain in opiate and non-opioid groups, and dexmedmodine is one of the drugs that has both analgesic and sedative effects. On the other hand, studies have shown that the use of this drug can reduce the incidence of delirium, acute kidney damage, arrhythmias and the need for opiate in cardiac surgery. Since the incidence of each of these complications increases costs, hospitalization length and hospitalization and morbidity and mortality after cardiac surgery, we found that the effect of this drug on the outcomes of patients undergoing cardiac surgery.
Design
This randomized, double-blind study will be performed on 120 patients undergoing cardiac surgery. All adult patients with cardiac surgery undergoing off pump surgery, and those patients are affiliated with oral opioids. Enter the studyAll Emergency / surgery with Pumps / and EF Under 30% / Addiction to iv opioids / This study will be conducted in the Department of Cardiac Surgery, Imam Reza Hospital, Mashhad, in 2017-2018 years . Expected outcomes 1. Reducing postoperative pain in open heart surgery patients 2. Reducing the number of ventilator days needed in open heart surgery patients 3. Reducing postoperative delirium in open heart surgery patients 4. Reducing the duration of mechanical ventilation in cardiac surgery patients 5. Reduced hospitalization time in ICU in open heart surgery patients 6. Reduced hospitalization time in open heart surgery patients 7. Reduced need for opioids in open heart surgery patients 8. Reduced prevalence and acute renal damage in patients with open heart surgery
Settings and conduct
This study was conducted blindly and based on random numbers of numbers in the Imam Reza Department of Surgery in the form of a randum triple.
Participants/Inclusion and exclusion criteria
All adult patients with cardiac surgery undergoing off pump surgery, and those patients are affiliated with oral opioids. Enter the studyAll Emergency / surgery with Pumps / and EF Under 30% / Addiction to iv opioids
Intervention groups
The aim of this study was to evaluate the effect of dexmedtomedine with placebo in two groups and its effects on pain, renal failure, arythemia, delirium, and mechanical ventilation.
Main outcome variables
Expected outcomes 1. Reducing postoperative pain in open heart surgery patients 2. Reducing the number of ventilator days needed in open heart surgery patients 3. Reducing postoperative delirium in open heart surgery patients 4. Reducing the duration of mechanical ventilation in cardiac surgery patients 5. Reduced hospitalization time in ICU in open heart surgery patients 6. Reduced hospitalization time in open heart surgery patients 7. Reduced need for opioids in open heart surgery patients 8. Reduced prevalence and acute renal damage in patients with open heart surgery

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150216021098N4
Registration date: 2018-03-10, 1396/12/19
Registration timing: registered_while_recruiting

Last update: 2018-03-10, 1396/12/19
Update count: 0
Registration date
2018-03-10, 1396/12/19
Registrant information
Name
Shahram Amini
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3852 5209
Email address
aminish@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2018-07-23, 1397/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Impact of Postoperative Dexmedetomidine on Outcomes of Orally Addicted Patients Undergoing Off Pump Coronary Artery Bypass Grafting
Public title
The Impact of Dexmedetomidine on Patients Undergoing Coronary Artery Bypass Grafting
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Adult patients with oral opium abuse undergoing elective off pump coronary artery bypass grafting
Exclusion criteria:
Use of Cardiopulmonary Pump Life threatening Arrhythmias Massive intraoperative Bleding Requring More Than 1 Unit of Packed RBC Use of Intraaortic Balloon Pump Need for High Dose Vasopressors Decline of Consent Sensitivity to Dexmedetomidine Ejection Fraction Less Than 30%
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Use of Computerized Randomization Table
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, Care Provider, Outcome Assessor, and the ِData Analyzer are Blind to the Study.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Sciences.daneshgah Ave;ghoreshi departeman
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Approval date
2017-07-23, 1396/05/01
Ethics committee reference number
IR.MUMS.fm.1396.143

Health conditions studied

1

Description of health condition studied
Coronary Artery By[pass Grafting
ICD-10 code
I25.7
ICD-10 code description
Atherosclerosis of coronary artery bypass graft(s) and coronary artery of transplanted heart with angina pectoris

2

Description of health condition studied
Opium Abuse
ICD-10 code
Z71.51
ICD-10 code description
Drug abuse counseling and surveillance of drug abuser

Primary outcomes

1

Description
Pain Severity
Timepoint
Every 1 hour
Method of measurement
NSR-CPOT

2

Description
Frequence of delireum
Timepoint
Every 8 hour
Method of measurement
ICAM

3

Description
Duration of Mechanical Ventilation
Timepoint
Every 1 hour
Method of measurement
Cornometer

4

Description
Need for Additional Opiates
Timepoint
Every 1 hour
Method of measurement
Dose Drug

Secondary outcomes

1

Description
Renal Failur
Timepoint
Daily until admitted
Method of measurement
Cratenin/ out put

Intervention groups

1

Description
Patients randomly divided into two groups according to the random numbers table. In the case group, the dexmedtomdin is administered at 1 μg / kg body weight in 15 minutes and then 0.2 μg / kg body weight per hour for 24 hours. In the placebo group, normal saline is infused. The variables will then be recorded
Category
Treatment - Drugs

2

Description
Control group: In the control group, normal saline is infused at the same rate for 24 hours and the variables will be recorded.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Reza hospital-ICU OH
Full name of responsible person
Akram Asadpour
Street address
Emam Reza squ, Emam Reza hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3852 5208
Fax
+98 51 3852 5208
Email
aminish@mums.ac.ir
Web page address
http://www.mums.ac.ir/newmums/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi (Pharm.D., Ph.D.)
Street address
GHoreyshi building, Daneshgah street, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
91775-1365
Phone
+98 51 3841 1538
Email
tafaghodim@mums.ac.ir
Web page address
http://v-research.mums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Shahram Amini
Position
Professor
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Emam Reza Hospital, Ebne sina street, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
91775-1365
Phone
+98 51 3882 2082
Fax
Email
aminish@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Shahram Amini
Position
Professor
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Department of Anesthesiology, Emam reza hospiral, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
91775-1365
Phone
+98 51 3852 5209
Fax
Email
aminish@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Akram Asadpour
Position
fellow of critical care
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Emam Reza Hospital, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
91775-1365
Phone
+98 51 3852 5208
Fax
Email
asadpoura951@mums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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