Protocol summary

Summary
Aim of this study was to valuate the effect of Mg Sulfate in post operative analgesia after oper heart surgery. Patients undergoing open heart surgery and have coronary disease or valve deformity for the first time.This patients disconnected from evaluation : those who have atrioventricular block or neurologic abnormalitis, sever obesity, pregnancy and organ abnormalities for example in kidney and liver, ... The research contain 44 patients undergoing oper heary surgery. we divided them 2 groups (22 patients ) in the frist group which we infused magnesium sulfate and in the second group we infused normal saline. induction of anesthesia with midazolame 0.1 mg/kg and sufentanyl 1 microgram/kg and pofol 1.5 mg/kg. In the preoperative phase monitoring made were 5 lead ECG, mean arterial pressure, central vein pressure, core temprature, oxygen blood saturation and co2 end tidal volume. evaluating the pain score (graphic VAS). In each two groups of evaluation after 30 minutes we evaluated these parameters pain score, difficult exubation, period of time staying in itensive care unit and nausea and vomiting.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201202159019N1
Registration date: 2012-06-06, 1391/03/17
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-06-06, 1391/03/17
Registrant information
Name
Ehsan Baghbani Jam
Name of organization / entity
Hamadan University of medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 9808118250851
Email address
e.baghbani@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University of Medical Sciences
Expected recruitment start date
2012-03-20, 1391/01/01
Expected recruitment end date
2013-03-21, 1392/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of Mg Sulfate in Post Operative Analgesia after Open Heart Surgery in coronary Ischemic Heart Disease
Public title
Effect of Mangnesium Sulfate in Heart Open Surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients undergoing open heart surgery ; those who have coronary artery disease or valve deformity for the first time.Exclusion criteria : This patients disconnected from evaluation : those have atrioventricular block ; neurologic abnormalitis; sever obesity; pregnancy ; organ abnormalities for example in kidney and liver, ...
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Hamadan university of medical sciences
Street address
shahid fahmideh st, ministry of research
City
Hamadan
Postal code
Approval date
2012-01-21, 1390/11/01
Ethics committee reference number
2752/16/35/پ/د

Health conditions studied

1

Description of health condition studied
Ischemic Heart Disease
ICD-10 code
I20-I25
ICD-10 code description
Ischaemic heart diseases

Primary outcomes

1

Description
Pain
Timepoint
after infusion of Mg after half hour
Method of measurement
graphic VAS system

Secondary outcomes

1

Description
nausa and vomiting
Timepoint
after infusion Mg after half hour
Method of measurement
inspection and clinical evaluation

Intervention groups

1

Description
Control group : Normal saline 150 ml intravenous line per 30 minutes
Category
Prevention

2

Description
Case group : Infusion of Magnesium sulfate 50 mg/kg in intravenous line per 30 minutes
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Ekbatan Hospital
Full name of responsible person
Ehsan Baghbani Jam
Street address
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Heidar Tavilani
Street address
Minsitry of Research
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamadan 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
Hamadan University of Medical Sciences
Full name of responsible person
Ehsan Baghbani Jam
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Ekbatan Hospital, Operative Room Ward
City
Hamadan
Postal code
Phone
+98 81 1825 1245
Fax
Email
e.baghbanijam@umsha.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Maryam Davoudi
Position
Associate of Anesthesiology
Other areas of specialty/work
Street address
Ekbatan Hospital, Operative Room Ward
City
Hamadan
Postal code
Phone
+98 81 1825 1245
Fax
Email
mdavoudi10@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Ehsan Baghbani Jam
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Ekbatan Hospital, Operative Room Ward
City
Hamadan
Postal code
Phone
+98 81 1825 1245
Fax
Email
Web page address

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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