A Comparison between the effects of Dexmedetomidine and Morphine used by patient-controlled anesthesia pump Method on controlling the side effects of Post-operative coronary bypass surgery in intensive care unit at Bushehr heart center in 1394 to 1395
Objective of the study: To compare the effects of two analgesics, Dexmedetomidine and Morphine used by patient-controlled anesthesia pump on the side effects of post operative coronary bypass surgery in Intensive Care Unit of Bushehr heart center in 2016 to 2017. This is a randomized, single-blinded trial containing interventional and control groups.
Methodology: The population is composed of 80 patients between the ages of 40 to 80 years who will be grouped into two groups of A and B.
Inclusion criteria: Ejection fraction percentage less than 35 %; Patients with informed refusal after the explanation of the procedures; Patients who need reoperation in the first 24 hours after the surgery; Drug Addiction.
Intervention: after randomization, Patients in group A( interventional group) will be subjected to patient-controlled Anesthesia pump containing 100 cc Normal Saline + 200 micro gram Dexmedetomidine + 4 mili gram Ondansetron with the rate of 0.7 micro gram per kilo gram per hour and group B (control) patients will be subjected to patient-controlled Anesthesia pump containing 10 miligram Morphine + 4miligram Ondansetron with the rate of 0.015 miligram per kilo gram per hour.
This study will be performed from 03/04/2016 to 19/03/2017.
Outcomes which will be measured and compared in this study between the groups are: severity of the pain, changes of Hemodynamic parameters, the amount of required Narcotic analgesias, the frequency of nausea and vomiting and also the level of sedation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016042427565N1
Registration date:2017-04-10, 1396/01/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-04-10, 1396/01/21
Registrant information
Name
Hosein Ashkpoor Motlagh
Name of organization / entity
Bushehr University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 77 3332 3846
Email address
h.ashkpoor@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Bushehr University of Medical Sciences
Expected recruitment start date
2016-04-03, 1395/01/15
Expected recruitment end date
2017-05-05, 1396/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparison between the effects of Dexmedetomidine and Morphine used by patient-controlled anesthesia pump Method on controlling the side effects of Post-operative coronary bypass surgery in intensive care unit at Bushehr heart center in 1394 to 1395
Public title
Comparing Dexmedetomidine and Morphine used Patient-Controlled Analgesia pump Method on controlling the side effects of Cardiac Surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Patients undergoing elective coronary artery bypass graft surgery.
Exclusion criteria: Ejection fraction percentage less than 35 %; patients who need reoperation in the first 24 hours after the surgery; Drug Addiction; Patients with informed refusal after the explanation of the procedures.
Age
From 40 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Bushehr university of medical science
Street address
Post code: 7514633341, Next to Tamin Ejtemaea Organisation, After Dadgostari Crossroads, Imam Qomeyni street, Bushehr
City
Bushehr
Postal code
7514633341
Approval date
2016-04-03, 1395/01/15
Ethics committee reference number
IR.BPUMS.rec.13940107
Health conditions studied
1
Description of health condition studied
general anesthesia
ICD-10 code
Y48.4
ICD-10 code description
Anaesthetic, unspecified
2
Description of health condition studied
cardiac surgery
ICD-10 code
T81.9
ICD-10 code description
Unspecified complication of procedure
Primary outcomes
1
Description
The intensity of analgesia
Timepoint
First 24 hours after surgery
Method of measurement
Visual analogue scale
2
Description
Systolic blood pressure
Timepoint
First 24 hours after surgery
Method of measurement
In millimeters of mercury using mercury manometer
3
Description
Diastolic blood pressure
Timepoint
First 24 hours after surgery
Method of measurement
In millimeters of mercury using mercury manometer
4
Description
Mean arterial pressure
Timepoint
First 24 hours after surgery
Method of measurement
(twice systolic blood pressure+diastolic blood pressure in millimeters of mercury and by mercury barometer) Divided by 2
Secondary outcomes
1
Description
Sedation level
Timepoint
First 24 hours after surgery
Method of measurement
By Ramsay sedation scale
2
Description
Heart rate
Timepoint
First 24 hours after surgery
Method of measurement
Measuring the radial pulse by palpation in one minute
3
Description
Nausea and Vomiting
Timepoint
First 24 hours after surgery
Method of measurement
Patient's self complaining
Intervention groups
1
Description
Intervention group: Dexmedetomidine 200 micro gram in 100 cc Normal Saline plus 4 mg Ondansetron in Patient-Controlled Anesthesia pump with infusion rate of 0.7 micro gram per kilogram per hour in the first 24 hours after the surgery
Category
Treatment - Drugs
2
Description
Control group: Morphine 10 milligram with 4 mg Ondansetron into pump with infusion rate of 0.015 micro gram per kilogram per hour in the first 24 hours after the surgery
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Heart hospital of Bushehr university of medical science
Full name of responsible person
DR AbdolRasool Anvaripoor
Street address
Postcode 7514633341, Heart hospital of Bushehr University of Medical science, Next to Tamin Ejtemaei Department, After Dadgostari Crossroads, Moalem street, Bushehr
City
Bushehr
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Bushehr University of Medical Sciences
Full name of responsible person
Mrs. Fatemeh Besharat Zadegan
Street address
Postcode 7514633341, Pardis Department of Bushehr university of Medical science, Rishehr Street, Bushehr
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, 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 Central Heart Department
Full name of responsible person
Doctor Abdol Rasool Anvaripoor
Position
Anesthesiologist
Other areas of specialty/work
Street address
Postcode 7514633341, Bushehr Heart Medical and Educational center, After Dadgostari Crossroad, Moalem Street, Bushehr
City
Bushehr
Postal code
7514633341
Phone
+98 77333321925
Fax
+98 77 3345 0235
Email
A.Anvari.p@hotmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bushehr Heart Medical and Educational center
Full name of responsible person
Doctor Abdol rasool Anvaripoor
Position
Anesthesiologist
Other areas of specialty/work
Street address
Post code 7514633341, Bushehr Heart Medical and Educational center, Next to Tamin Ejtemaei ِDepartment, After Dadgostari Crossroads, Moalem street, Bushehr
City
Bushehr
Postal code
7514633341
Phone
+98 77333321925
Fax
+98 77 3345 0235
Email
A.Anvari.p@hotmail.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)