Evaluation of comparison between Remifentanil infusion and single dose intravenous Hydralazine + Propranolol administration to provide controlled hypotension in patients undergoing Rhino plastic surgery in khalili hospital during 2014-2015
Study purpose: evaluation and comparison between Remifentanil infusion and single dose intravenous Hydralazine + Propranolol administration to provide controlled hypotension in patients undergoing Rhino plastic surgery.
Method: the sample size in this study is 80 students divided into two groups A and B with 40 members in the age range of 40-20 years.
Interventions: group A, besides induction of anesthesia , received 1 mg Inderal and 20 mg Hydralazine. In group B patients are tested under Remifentanil infusion at a rate of 0.1 -0.3 mcg / kg / min.
Primary outcome measure: blood pressure decrease and heartbeat rate in two groups A and B.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015101522173N2
Registration date:2015-12-09, 1394/09/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-12-09, 1394/09/18
Registrant information
Name
Behshid Javidsharify
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3624 2410
Email address
javidsharify@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2015-11-22, 1394/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of comparison between Remifentanil infusion and single dose intravenous Hydralazine + Propranolol administration to provide controlled hypotension in patients undergoing Rhino plastic surgery in khalili hospital during 2014-2015
Public title
Evaluation of comparison between Remifentanil infusion and single dose intravenous Hydralazine + Propranolol administration to provide controlled hypotension in patients undergoing Rhino plastic surgery in khalili hospital during 2014-2015
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: all patients in the range of 20-40 years old with class I ASA.
Exclusion criteria: patients in class II & III ASA; recent (the last 3 months) general anesthesia record; drug abuse; history of allergy to Propranolol or Hydralazine or Remifentanil; high blood pressure; cardiovascular diseases should be eliminated.
Age
From 20 years old to 40 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)
Not 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
Street address
Shiraz University of Medical Sciences, Zand St
City
Shiraz
Postal code
Approval date
2015-09-13, 1394/06/22
Ethics committee reference number
IR.SUMS.REC.1394.115
Health conditions studied
1
Description of health condition studied
Hypertension
ICD-10 code
I10-I15
ICD-10 code description
Hypertensive diseases
Primary outcomes
1
Description
Blood pressure
Timepoint
Before intervention, during intervention, after intervention
Method of measurement
In terms of mmHg, using a Mercury sphygmomanometer
Secondary outcomes
1
Description
Bleeding during surgery
Timepoint
After intervention
Method of measurement
According to surgeon report
Intervention groups
1
Description
In group B patients are tested under Remifentanil infusion at a rate of 0.1 -0.3 mcg / kg / min .
Category
Treatment - Drugs
2
Description
Group A, besides induction of anesthesia , received 1mg Inderal and 20mg Hydralazine.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khalili Hospital
Full name of responsible person
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Ghazipour
Street address
Shiraz University of Medical Sciences, Zand St.
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Seyyed Ebrahim Sadeghi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, Zand St.
City
Shiraz
Postal code
Phone
+98 71 3227 4250
Fax
Email
esadeghi@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Seyyed Ebrahim Sadeghi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, Zand St.
City
Shiraz
Postal code
Phone
+98 71 3227 4250
Fax
Email
esadeghi@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Technology
Full name of responsible person
Mahshid Javidsharifi
Position
PhD student
Other areas of specialty/work
Street address
Modarres Blvd
City
Shiraz
Postal code
7188636365
Phone
+98 71 3624 2410
Fax
Email
msh.javid@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)