Bring appropriate environment without bleeding in Rhinoplasty surgery ، one of the main goals of anesthetic management of these patients is .One of the ways to achicve this goals to induce hypotension.60 Patients Male or Female ranging in age 18 to 50 years، with ASA 1-2 and blood pressure higher 100/70 mm/Hg،Heart rate above 40 minute candidate for Rhinoplasty surgery after obtaining permission from the Ethics Committee Shiraz University of Medical Sciences and informed consent are studied. Patients whose Blood pressure less than 100/70 mm/Hg ،Heart rate less than 40 minute ، Heart disease ،Hypertension ، Obestractive lung disease and Coagulation problems are to the Excluded. Patients were systematically and randomly divided into groups of 30 groups according to a table of random numbers are. Anesthesia is the same in both groups.After being anesthetized patients before surgical incision to maintain mean arterial pressure of 55-65 mm/Hg range Labetalol drug in 30 patients and 30 patients drug Remifentanil found. Beginning of the operation Mean Atrial Pressure (MAP) and Heart rate every 15 minute Record ;Bleeding during the operation by suction are collected.At the end of surgery with respect to the amount of blood in the suction and evaluate the quality of the surgical site by the surgen in the operative bleeding is cheeked.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT20140223N115938
Registration date:2014-02-23, 1392/12/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-02-23, 1392/12/04
Registrant information
Name
Abdoreza Gholami
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1233 0409
Email address
gholami_a@internet.sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2014-02-20, 1392/12/01
Expected recruitment end date
2014-08-23, 1393/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of Remifentanil and Labetalol infusion on intraoperative bleeding during Rhinoplasty surgery
Public title
Blood loss in Rhinoplasty surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion:The patient with ASA 1-2 ;Men or Women between 18- 50 years; Disease without surgery Rhinoplasty;No patient had a history or physical exam of clotting problems; Blood pressure above then 100/70 mm/Hg ;Heart rate above then 40 mint;No history of Obstractive lung disease and Heart disease .
Exclusion criteria: Patient with ASA above 2;Men or Women with Age less then 18 years and age above then 50 years; Repeat Rhinoplasty surgery ;Coagulation problem in history and physical exam;Blood pressure less then100/70mm/Hg;Heart rate less then 40 mint;History Obstractive lung disease and any Heart disease.
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences، Research
Street address
Research ، Central Building Danesgah، Zand Blvd
City
Shiraz
Postal code
713451978
Approval date
2014-01-12, 1392/10/22
Ethics committee reference number
ct-p-92-5265
Health conditions studied
1
Description of health condition studied
q00-q99
ICD-10 code
q30-q34
ICD-10 code description
q30/9 -Congenital Malformation of nose ، Unspecitied
Primary outcomes
1
Description
The amount of intraoperative bleeding
Timepoint
The end of surgery
Method of measurement
Measurement of blood in the suction
2
Description
Evaluate the quality of the surgical site by the Surgen
Timepoint
The end of surgery
Method of measurement
Evaluate with table Boezaart by Surgen
Secondary outcomes
1
Description
Mean Artrial Pressure
Timepoint
During the study every 15 minute
Method of measurement
Pressure Set-Blood Pressure Monitoring
2
Description
Heart Rate
Timepoint
During the study every 15 minute
Method of measurement
Anesthesia Monitoring
Intervention groups
1
Description
After being anesthetized patients before surgical incision a group of 30 patients drug Labetalol with dose /4-3 mg/ kg/hr beginning to the end of the operation with a 50 cc syringe infusion pump operation will start. Mean Arterial Pressure (MAP) is in the range of 55-65 mm/Hg .In this area we have to see how much bleeding.
Category
Treatment - Drugs
2
Description
After being anesthetized patients before surgical incision a group of 30 patients drug Remifentanil with dose /1-3 mic/kg/min beginning to the end of the operation with a 50cc syringe infusion pump operation will start. Mean Arterial Pressure( MAP) is in the range of 55-65 mm/Hg .In the area we have to see how much bleeding.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dastgheb Hospital
Full name of responsible person
Abdoreza Gholami
Street address
Dastgheb Hospital ، Hafez Ave
City
Shiraz
2
Recruitment center
Name of recruitment center
Mother Child Hospital
Full name of responsible person
Abdoreza Gholami
Street address
Mother Child Hospital، Reza Blvd
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraze University of Medical Sciences ،Researh
Full name of responsible person
Dr.GHolamreza Hatam
Street address
Research، Central Buling Danesgah ، Zand Blvd
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?