The aim of this study was the use of oral clonidine to reduce blood pressure and reduce bleeding and to stabilize the hemodynamic changes thus reduce bleeding and having a clear field of action in the treatment of mandibular fractures surgery. The patients studied were ASA class I or II of the groupings. Patients with a positive medical history of systemic disease or high blood pressure and low blood pressure, liver and kidney disease, and cardiovascular or cerebrovascular disease who had received any medication during the last two weeks were excluded.86 patients of both sexes with an age range of 15-35 years were studied.Patients were divided into two groups of 43. Clonidine group .1 mg clonidine and a placebo to the control group received 60 minutes preoperative. Hemodynamic changes in both groups preoperative and interaoperative the ten-minute intervals and the end of operative recording is bleeding. Finally, the two groups are compared.The trial is a randomized, double-blind .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012091610853N1
Registration date:2012-10-09, 1391/07/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-10-09, 1391/07/18
Registrant information
Name
Omid Ghasemzadeh
Name of organization / entity
Jondishapoor University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1372 7219
Email address
ghasemzadeh.o@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
State
Expected recruitment start date
2011-03-01, 1389/12/10
Expected recruitment end date
2012-04-18, 1391/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of clonidine premedication on intraoperative Hemodynamic changes and Blood loss in mandibular fracture surgery .
Public title
Effect of clonidine on hemodynamic changes and bleeding
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria : Groupings of men and women in the class I or II ASA; men and women between 15 to 35 years Exclusion criteria: Patients with a positive medical history of systemic diseases
Age
From 15 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
86
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
Jondishapoor University of Medical Sciences
Street address
Jondishapoor University of Medical Sciences ̦ Golestan Alley ̦ Ahvaz ̦ Khozestan
City
Ahvaz
Postal code
iran
Approval date
2011-03-01, 1389/12/10
Ethics committee reference number
u-89237
Health conditions studied
1
Description of health condition studied
Fracture of mandible
ICD-10 code
S02.6
ICD-10 code description
Fracture of mandible
Primary outcomes
1
Description
blood loss and hemodynamic changes
Timepoint
preoperative and Intraoperative
Method of measurement
ml and mmH.g with manometer
Secondary outcomes
1
Description
The consumption of morphine and fentanyl, and remifentanil
Timepoint
intraoperative
Method of measurement
Micro g/ kg and mg/ kg
Intervention groups
1
Description
In treatment group 1. Clonidine mg given orally one hour before surgery. Blood pressure, heart rate and mean arterial pressure one hour before surgery and during the specified times for 10 minutes and are recorded and bleeding at the end of the operation is calculated .This trial is a randomized, double-blind
Category
Treatment - Surgery
2
Description
In the control group given a placebo an hour before surgery . Blood pressure, heart rate and mean arterial pressure one hour before surgery and during the specified times for 10 minutes and are recorded and bleeding at the end of the operation is calculated
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Khomeini Hospital
Full name of responsible person
Omid Ghasemzadeh-Residenents of maxillofacial surgery
Street address
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for research -Ahvaz Jondishapur University of Medical Science
Full name of responsible person
dr.mostafa feghhi
Street address
Vice-chancellor for research -Ahvaz Jondishapur University of Medical Science
City
Ahvaz
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 -Ahvaz Jondishapur University of Medical Science
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
Ahvaz University of Medical Sciences
Full name of responsible person
Omid Ghasemzadeh
Position
Resident
Other areas of specialty/work
Street address
emam hospital department of oral and maxillofacial surgery
City
Ahvaz
Postal code
Phone
+98 61 1372 7219
Fax
Email
ghasemzadeho@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Omid Ghasemzadeh
Position
Resident
Other areas of specialty/work
Street address
emam hospital
City
Ahvaz
Postal code
Phone
+98 61 1372 7219
Fax
Email
ghasemzadeho@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Omid Ghasemzadeh
Position
Resident
Other areas of specialty/work
Street address
emam khomeini hospital
City
ahvaz
Postal code
Phone
+98 61 1372 7219
Fax
Email
ghasemzadeho@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)