A comparative study on the effect of two compounds of Propofol-Remifentanil and Propofol-Hydralazine on volume of blood loss during dacryocystorhinostomy with general anesthesia
Determination and comparison of the effect of two compounds of propofol-remifentanil and propofol-hydralazine on bleeding volume during dacryocystorhinostomy surgery under general anesthesia
Design
A three phase clinical trial with two intervention groups, in parallel, double-blind, randomized with simple method, with sample size of 80
Settings and conduct
This study will be conducted in Isfahan Feiz hospital in 1389-1388. Patients are divided into two groups.At first, 5 cc/kg of crystalloid fluid is injected and 100% oxygen is given by the mask in the first 3 minutes. Anesthesia is induced by injection of 2 μg/kg fentanyl, 2 mg/kg propofol and 0.5 mg/kg atracurium, and intubation is done.In both groups, propofol infusion will be started at a dose of 12 mg/kg/hr (200 µg/kg/min) and then reduced to 6-10 mg / kg / hr (150-50 µg/kg/min).In group A 40 cc propofol plus 0.15 µg/kg remifentanil and in group B the same amount of propofol with 20 mg hydralazine is prepared and the infusion would start at a dose of 50-150 µg/kg/min.At last the volume of blood collected in the suction is recorded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
ASA I, II patients who are candidates for DCR surgery
Age range 18 to 80 years
No contraindication for Hydralazine, Remifentanil and Propofol
Consent to participate in the study
Exclusion criteria:
Known allergies to medicines
Having heart disease
Having diabetes mellitus
Obvious anemia
Having hemoglobinopathy
Having polycythemia
Having liver disease
Ischemic cerebrovascular disease
Having respiratory failure
Systemic hypertension
Any complication that may alter the anesthesia program
Occurrence of complications such as heart block, etc. that prohibit or restrict the continuation of the intervention
Intervention groups
1
Main outcome variables
Bleeding volume, Blood pressure, Heart rate,recovery time, Extubation time, Surgeon satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171030037093N30
Registration date:2020-02-05, 1398/11/16
Registration timing:prospective
Last update:2020-02-05, 1398/11/16
Update count:0
Registration date
2020-02-05, 1398/11/16
Registrant information
Name
Sadra Ansaripour
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3650 3487
Email address
st_ansari.s@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2021-05-22, 1400/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study on the effect of two compounds of Propofol-Remifentanil and Propofol-Hydralazine on volume of blood loss during dacryocystorhinostomy with general anesthesia
Public title
Comparison of the effect of two compounds of Propofol-Remifentanil and Propofol-Hydralazine on volume of blood loss during dacryocystorhinostomy with general anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
ASA I, II patients who are candidates for DCR surgery
Age range 18 to 80 years
No contraindication for Hydralazine, Remifentanil and Propofol
Consent to participate in the study
Exclusion criteria:
Known allergies to medicines
Having heart disease
Having diabetes mellitus
Obvious anemia
Having hemoglobinopathy
Having polycythemia
Having liver disease
Ischemic cerebrovascular disease
Having respiratory failure
Systemic hypertension
Any complication that may alter the anesthesia program
Occurrence of complications such as heart block, etc. that prohibit or restrict the continuation of the intervention
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Patients included in the study are randomly assigned into two groups using Random allocation computer software with the simple method.
Blinding (investigator's opinion)
Double blinded
Blinding description
Because the patient is unaware of the type of drug used and the anesthesiologist is unaware of the type of intervention, this is a double-blind study.
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
Isfahn University of Medical Sciences, Hezar jarib st, Isfahan
City
Isfahan
Province
Isfehan
Postal code
7346181746
Approval date
2019-07-31, 1398/05/09
Ethics committee reference number
IR.MUI.MED.REC.1398.528
Health conditions studied
1
Description of health condition studied
Blood loss during surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Bleeding volume
Timepoint
After intervention
Method of measurement
Suction
Secondary outcomes
1
Description
Blood pressure
Timepoint
Before and after intervention
Method of measurement
Non-invasive automatic barometer
2
Description
Heart rate
Timepoint
Before and after intervention
Method of measurement
Pulse Oximeter
3
Description
Length of staying in recovery
Timepoint
After intervention
Method of measurement
Modified Aldrete Score
4
Description
Surgeon satisfaction
Timepoint
After intervention
Method of measurement
likert scale
Intervention groups
1
Description
First intervention group:In group A in a 50 cc syringe 40 cc propofol with 0.15 μg / kg remifentanil is prepared and eventually the infusion at a dose of 50-150 μg/kg/min will be started. At the end of surgery, blood volume in the suction is observed and recorded.
Category
Treatment - Drugs
2
Description
Second intervention group:In group B, 40 cc of propofol with 20 mg of hydralazine will be prepared and the infusion will eventually start at a dose of 50-150 µg / kg / min. At the end of surgery, the volume of blood collected in the suction is observed and recorded.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Feiz Hospital
Full name of responsible person
Hamidreza Shetabi
Street address
Isfahan Province, Isfahan, Modarres St
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3445 2031
Email
Hamidrezashetabi@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ziba Farajzadegan
Street address
Isfahan University of Medical Sciences, Hezar jarib Avne
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 0048
Email
farajzadegan@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
Hamidreza Shetabi
Position
Professor of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Modarres street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 1992
Email
hamidrezashetabi@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamidreza Shetabi
Position
Professor of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Modarres street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 1992
Email
hamidrezashetabi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamidreza Shetabi
Position
Professor of Anesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Modarres street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 1992
Email
hamidrezashetabi@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available