Comparison of the Effectiveness of intravenous bolus Ephedrine and Norepinephrine for the reduction of Hypotension in general Anesthesia in patient with Hypertension
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Protocol summary
The patients are selected in Rasool Akram Hospital operating room.For treatment of hypotension an Ephedrine dose of 5 milligram is injected into the Ephedrine group and MAP is recorded after 5 minutes. An Nor epinephrine dose of 5 microgram is injected into the Nor epinephrine group and MAP is recorded after 2 minutes. In each group, if MAP does not reach 60, the dose is repeated up to 3 times.Changes in MAP, Heart Rate and frequency of drug injection are compared in two groups.
The patients are selected in Rasool Akram Hospital operating room.For treatment of hypotension an Ephedrine dose of 5 milligram is injected into the Ephedrine group and MAP is recorded after 5 minutes. An Nor epinephrine dose of 10 microgram is injected into the Nor epinephrine group and MAP is recorded after 2 minutes. In each group, if MAP does not reach 60, the dose is repeated up to 3 times.Changes in MAP, Heart Rate and frequency of drug injection are compared in two groups.
The patients are selected in Rasool Akram Hospital operating room.For treatment of hypotension an Ephedrine dose of 5 milligram is injected into the Ephedrine group and MAP is recorded after 5 minutes. An Nor epinephrine dose of 510 microgram is injected into the Nor epinephrine group and MAP is recorded after 2 minutes. In each group, if MAP does not reach 60, the dose is repeated up to 3 times.Changes in MAP, Heart Rate and frequency of drug injection are compared in two groups.
بیماران در اتاق عمل بیمارستان رسول اکرم انتخاب می شوند .جهت درمان هیپوتنشن به گروه افدرین 5 میلی گرم افدرین تزریق می شود و پس از 5 دقیقه MAP ثبت می شود .به گروه نوراپی نفرین 5 میکرو گرم نوراپی نفرین تزریق می شود و پس از 2 دقیقه MAP ثبت می شود .در هر گروه اگر MAP به بالای 60 نرسد ، دوز تا 3 بار تکرار می شود .تغییرات MAP ضربان قلب و دفعات تزریق دارو در دو گروه مقایسه میشود.
بیماران در اتاق عمل بیمارستان رسول اکرم انتخاب می شوند .جهت درمان هیپوتنشن به گروه افدرین 5 میلی گرم افدرین تزریق می شود و پس از 5 دقیقه MAP ثبت می شود .به گروه نوراپی نفرین 10 میکرو گرم نوراپی نفرین تزریق می شود و پس از 2 دقیقه MAP ثبت می شود .در هر گروه اگر MAP به بالای 60 نرسد ، دوز تا 3 بار تکرار می شود .تغییرات MAP ضربان قلب و دفعات تزریق دارو در دو گروه مقایسه میشود.
بیماران در اتاق عمل بیمارستان رسول اکرم انتخاب می شوند .جهت درمان هیپوتنشن به گروه افدرین 5 میلی گرم افدرین تزریق می شود و پس از 5 دقیقه MAP ثبت می شود .به گروه نوراپی نفرین 510 میکرو گرم نوراپی نفرین تزریق می شود و پس از 2 دقیقه MAP ثبت می شود .در هر گروه اگر MAP به بالای 60 نرسد ، دوز تا 3 بار تکرار می شود .تغییرات MAP ضربان قلب و دفعات تزریق دارو در دو گروه مقایسه میشود.
Ephedrine group:1 milliliter of Ephedrine 5 milligram per milliliter
Nor epinephrine group; 1 Milliliter of Nor epinephrine 5 micrograms per milliliter
Ephedrine group:1 milliliter of Ephedrine 5 milligram per milliliter
Nor epinephrine group; 1 Milliliter of Nor epinephrine 10 micrograms per milliliter
Ephedrine group:1 milliliter of Ephedrine 5 milligram per milliliter Nor epinephrine group; 1 Milliliter of Nor epinephrine 510 micrograms per milliliter
گروه افدرین :1 میلی لیتر از داروی افدرین 5 میلی گرم در میلی لیتر بولوس وریدی
گروه نوراپی نفرین: 1 میلی لیتر از داروی نوراپی نفرین 5 میکرو گرم در میلی لیتر بولوس وریدی
گروه افدرین :1 میلی لیتر از داروی افدرین 5 میلی گرم در میلی لیتر بولوس وریدی
گروه نوراپی نفرین: 1 میلی لیتر از داروی نوراپی نفرین 10 میکرو گرم در میلی لیتر بولوس وریدی
گروه افدرین :1 میلی لیتر از داروی افدرین 5 میلی گرم در میلی لیتر بولوس وریدی گروه نوراپی نفرین: 1 میلی لیتر از داروی نوراپی نفرین 510 میکرو گرم در میلی لیتر بولوس وریدی
General information
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2017-12-22, 1396/10/01
2017-01-04, 1395/10/15
2017-1201-2204 00:00:00
2018-06-20, 1397/03/30
2018-03-20, 1396/12/29
2018-0603-20 00:00:00
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2017-01-04, 1395/10/15
2017-01-04 00:00:00
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2017-12-22, 1396/10/01
2017-12-22 00:00:00
Intervention groups
#1
Intervention group: :Norepinephrine Group : After a mean arterial pressure (MAP) drop to less than 60 millimeter Hg، one milliliter of Norepinephrine with a concentration of three micrograms per milliliter، is injected intravenous bolus.
Intervention group: :Norepinephrine Group : After a mean arterial pressure (MAP) drop to less than 60 millimeter Hg، one milliliter of Norepinephrine with a concentration of 10 micrograms per milliliter، is injected intravenous bolus.
Intervention group: :Norepinephrine Group : After a mean arterial pressure (MAP) drop to less than 60 millimeter Hg، one milliliter of Norepinephrine with a concentration of three10 micrograms per milliliter، is injected intravenous bolus.
گروه مداخله: پس از افت متوسط فشار شریانی (MAP) به کمتر از 60 میلیمتر جیوه ، یک میلی لیتر از نوراپی نفرین با غلظت پنج میکروگرم در میلی لیتر از طریق وریدی بولوس تزریق می شود و بعد از دو دقیقه در صورت عدم افزایش MAP به بیش از 60 ، تا سه دوز تکرار می شود
گروه مداخله: پس از افت متوسط فشار شریانی (MAP) به کمتر از 60 میلیمتر جیوه ، یک میلی لیتر از نوراپی نفرین با غلظت ده میکروگرم در میلی لیتر از طریق وریدی بولوس تزریق می شود و بعد از دو دقیقه در صورت عدم افزایش MAP به بیش از 60 ، تا سه دوز تکرار می شود
گروه مداخله: پس از افت متوسط فشار شریانی (MAP) به کمتر از 60 میلیمتر جیوه ، یک میلی لیتر از نوراپی نفرین با غلظت پنجده میکروگرم در میلی لیتر از طریق وریدی بولوس تزریق می شود و بعد از دو دقیقه در صورت عدم افزایش MAP به بیش از 60 ، تا سه دوز تکرار می شود
Protocol summary
Study aim
To compare the efficacy of intravenous bolus Nor epinephrine in compensating for hypotension during general anesthesia with intravenous Ephedrine
Design
56Patients who undergo general anesthesia for spinal surgery who have MAP below 60 millimeter Hg, are randomly divided into Ephedrine and Nor epinephrine groups.
Settings and conduct
The patients are selected in Rasool Akram Hospital operating room.For treatment of hypotension an Ephedrine dose of 5 milligram is injected into the Ephedrine group and MAP is recorded after 5 minutes. An Nor epinephrine dose of 10 microgram is injected into the Nor epinephrine group and MAP is recorded after 2 minutes. In each group, if MAP does not reach 60, the dose is repeated up to 3 times.Changes in MAP, Heart Rate and frequency of drug injection are compared in two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 20-75 years old؛ History of Hypertension؛ Patients undergo general anesthesia for spinal surgery؛ MAP below 60 millimeter Hg during anesthesia
Exclusion criteria: History of cardiac arrhythmia؛ valvular heart disease ؛ cerebral vascular disease؛ renal failure ؛ diabetes؛ Using Beta blocker drugs
Intervention groups
Ephedrine group:1 milliliter of Ephedrine 5 milligram per milliliter
Nor epinephrine group; 1 Milliliter of Nor epinephrine 10 micrograms per milliliter
Main outcome variables
Mean Arterial Pressure
Heart rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180110038296N1
Registration date:2018-01-28, 1396/11/08
Registration timing:retrospective
Last update:2018-06-23, 1397/04/02
Update count:1
Registration date
2018-01-28, 1396/11/08
Registrant information
Name
Sahar Masghati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 86709
Email address
masghati.s@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-01-04, 1395/10/15
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
2017-01-04, 1395/10/15
Actual recruitment end date
2017-12-22, 1396/10/01
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of intravenous bolus Ephedrine and Norepinephrine for the reduction of Hypotension in general Anesthesia in patient with Hypertension
Public title
Effect of Ephedrine and Norepinephrine in treatment of hypotension in general anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20 ti 75 years old
History of Hypertension
General anesthesia in spinal surgery
Mean arterial pressure below 60 millimeter Hg during anesthesia
Exclusion criteria:
History of cardiac arrhythmia
History of valvular heart disease
History of cerebral vascular disease
History of renal failure
Use Beta blocker drugs
History of diabetes
Age
From 20 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
56
Actual sample size reached:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Simple
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and Care workers
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences Sciences
Street address
Next to Milad Tower., Hemmat HighWay
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2017-05-23, 1396/03/02
Ethics committee reference number
IR.IUMS.REC 1396.9311174021
Health conditions studied
1
Description of health condition studied
Hypotension
ICD-10 code
I95.9
ICD-10 code description
Hypotension, unspecified
Primary outcomes
1
Description
Mean Arterial Pressure
Timepoint
During Anesthesia
Method of measurement
Radial artery catheter
2
Description
Heart rate
Timepoint
During anesthesia
Method of measurement
Using a monitoring device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Ephedrine Group: After a mean arterial pressure (MAP) drop to less than 60 millimeter Hg، one milliliter of Ephedrine with a concentration of five milligrams per milliliter، is injected intravenous bolus.
Category
Treatment - Drugs
2
Description
Intervention group: :Norepinephrine Group : After a mean arterial pressure (MAP) drop to less than 60 millimeter Hg، one milliliter of Norepinephrine with a concentration of 10 micrograms per milliliter، is injected intravenous bolus.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasool Akram Hospital
Full name of responsible person
Sahar Masghati
Street address
Niayesh Ave.,Satarkhan Ave
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6435 2326
Email
saharmasghati@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyyed Kazem Malakooti
Street address
Next to Milad Tower, Hemmat Highmay
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
PR@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?