Comparative Study on the Effect of two Labetalol-Nitroglycerine Combinations withLabetalol-Hydralazine on volume blood loss During Ducriocysturinostomy with Local Anesthesia
Evaluation of the effect of combination of two drug combinations of labetalol-tri-nitroglycerin with labetalol-hydralazine on bleeding volume during dacryocystorhinostomy with local anesthesia
Design
The present study is a double-blind clinical trial (the patient and the registrant are unaware of the type of drug used) that will be performed at Feyz Isfahan Medical Center in 1397-98. Patients undergoing DCR surgery They are not contraindicated with hydralazine, tri-nitroglycerin and labetalol and are in the age range of 18 to 80 years.
Settings and conduct
at Feyz Isfahan Medical Center in 1397-98
Participants/Inclusion and exclusion criteria
Patients undergoing DCR surgery who are not contraindicated with hydralazine, tri-nitroglycerin and labetalol and are in the age range of 18 to 80 years
2. Patient consent for inclusion in the study
Patient Exclusion Criteria:
1. A known allergy to medicines
2. Heart disease
3. Diabetes mellitus, prominent anemia
4- Hemoglobinopathy
5. Polycythemia
6. Liver disease
7- Cerebrovascular ischemic disease
8- Respiratory failure
9. Systemic hypertension
Intervention groups
Group A recipient of labetalol-tri-nitroglycerin and group B recipient of labetalol-hydralazine
Main outcome variables
Determination and Comparison of Mean Bleeding Volume in Labetalol-Trititroglycerin Consumption Group with Labetalol-Hydralazine Consumption Group
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190626044020N1
Registration date:2019-12-29, 1398/10/08
Registration timing:retrospective
Last update:2019-12-29, 1398/10/08
Update count:0
Registration date
2019-12-29, 1398/10/08
Registrant information
Name
Elnaz Marzbani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 4253 5407
Email address
dr.marzbani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Study on the Effect of two Labetalol-Nitroglycerine Combinations withLabetalol-Hydralazine on volume blood loss During Ducriocysturinostomy with Local Anesthesia
Public title
Comparative Study on the Effect of two Labetalol-Nitroglycerine Combinations withLabetalol-Hydralazine on volume blood loss During Ducriocysturinostomy with Local Anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing DCR surgery who are not contraindicated with hydralazine, tri-nitroglycerin, and labetalol, aged 18 to 80 years
Patient Satisfaction for Inclusion
Exclusion criteria:
Known allergies to medicines
Heart disease
Diabetes mellitus, obvious anemia
Hemoglobinopathy
Polycythemia
Liver disease
Cerebrovascular ischemic disease
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Simple randomization
Randomization Unit: Individual
Randomization Tool: Random Number Table
Blinding (investigator's opinion)
Double blinded
Blinding description
Blindness is that after giving the patient complete information. If there are no criteria for exclusion, the patient will be entered into the study after obtaining informed consent. The patient is not informed about the type of medication used during the study. They also do not know the type of medication used when assistants and health care providers gather information
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Daneshgah street, Isfahan University of Medical Sciences
City
Esfahan
Province
Isfehan
Postal code
81746443446
Approval date
2018-06-27, 1397/04/06
Ethics committee reference number
IR.MUI.MED.REC.1398.004
Health conditions studied
1
Description of health condition studied
stenosis and insufficiency of lacrimal passages
ICD-10 code
H04.5
ICD-10 code description
stenosis and insufficiency of lacrimal passages
Primary outcomes
1
Description
Determination of the mean volume of bleeding in Dacryocystorhinostomy to CC
Timepoint
The volume of blood collected in the suction device at the end of surgery
Method of measurement
Blood collected in suction to cc
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: After the patient is placed on the baseline monitoring bed including systolic blood pressure, diastolic blood pressure, heart rate and respiratory rate. Then, local anesthesia will be performed by the surgeon using 8 cc lidocaine 2% in both groups. Both groups are given a boletabolol dose of 20 mg within 2 minutes. Doses and rate of intravenous injection are selected based on the policy for hypertension crisis. Then the infusion of labetalol at a rate of 0.5 - 1 mg / min and the maximum dose received will be 300 mg. Group A patients start intravenous infusion of Tri-nitroglycerin 15 - 20 mcg / min from the lower limit and increase every 5 minutes if necessary to reach target MAP.
Category
Treatment - Drugs
2
Description
Intervention group 1: After the patient is placed on the baseline monitoring bed including systolic blood pressure, diastolic blood pressure, heart rate and respiratory rate. Then, local anesthesia will be performed by the surgeon using 8 cc lidocaine 2% in both groups. Both groups are given a boletabolol dose of 20 mg within 2 minutes. Doses and rate of intravenous injection are selected based on the policy for hypertension crisis. Then the infusion of labetalol at a rate of 0.5 - 1 mg / min and the maximum dose received will be 300 mg. In group B, hydralazine is given 0.5 - 1 mg / min intravenous infusion. The level starts from the lower limit if necessary, increasing every 5 minutes to achieve target MAP.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Feyz Isfahan Medical Center
Full name of responsible person
Dr Ali Salehi
Street address
Modarres street
City
Esfahan
Province
Isfehan
Postal code
8174643446
Phone
+98 31 3445 7701
Fax
+98 31 3445 7701
Email
Feyz@mui.ac.ir
Web page address
Http://www.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Syed Morteza Heydari
Street address
Daneshgah street, Isfahan University of Medical Sciences
City
Esfahan
Province
Isfehan
Postal code
8174643446
Phone
+98 31 3668 5555
Fax
+98 31 3668 5555
Email
M_heidari@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Syed Morteza Heydari
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Daneshgah street, Isfahan University of Medical Sciences
City
Esfahan
Province
Isfehan
Postal code
8174643446
Phone
+98 31 3445 7701
Fax
+98 31 3445 7701
Email
M_heidari@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Syed Morteza Heydari
Position
Profossor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Daneshgah street, Isfahan University of Medical Sciences
City
Esfahan
Province
Isfehan
Postal code
8174643446
Phone
+98 31 3668 5555
Fax
+98 31 3668 5555
Email
M_heidari@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Syed Morteza Heydari
Position
Profossor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Daneshgah street, Isfahan University of Medical Sciences
City
Esfahan
Province
Isfehan
Postal code
8174643446
Phone
+98 31 3668 5555
Fax
+98 31 3668 5555
Email
M_heidari@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Confidentiality of information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data and documentation will be available except personal patient information
When the data will become available and for how long
unlimited
To whom data/document is available
unlimited
Under which criteria data/document could be used
For scientific and expansive use of research
From where data/document is obtainable
Isfahan University of Medical Sciences Library
What processes are involved for a request to access data/document