Protocol summary
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Study aim
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To compare the efficacy of intravenous bolus Nor epinephrine in compensating for hypotension during general anesthesia with intravenous Ephedrine
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Design
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56Patients who undergo general anesthesia for spinal surgery who have MAP below 60 millimeter Hg, are randomly divided into Ephedrine and Nor epinephrine groups.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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Ephedrine group:1 milliliter of Ephedrine 5 milligram per milliliter
Nor epinephrine group; 1 Milliliter of Nor epinephrine 10 micrograms per milliliter
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Main outcome variables
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Mean Arterial Pressure
Heart rate
General information
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Reason for update
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Acronym
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IRCT registration information
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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
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Registration date
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2018-01-28, 1396/11/08
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2017-01-04, 1395/10/15
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Expected recruitment end date
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2018-03-20, 1396/12/29
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Actual recruitment start date
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2017-01-04, 1395/10/15
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Actual recruitment end date
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2017-12-22, 1396/10/01
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Trial completion date
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empty
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Scientific title
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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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Public title
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Effect of Ephedrine and Norepinephrine in treatment of hypotension in general anesthesia
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 20 years old to 75 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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- Participant
- Care provider
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Sample size
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Target sample size:
56
Actual sample size reached:
56
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Simple
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Patients and Care workers
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-05-23, 1396/03/02
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Ethics committee reference number
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IR.IUMS.REC 1396.9311174021
Health conditions studied
1
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Description of health condition studied
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Hypotension
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ICD-10 code
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I95.9
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ICD-10 code description
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Hypotension, unspecified
Primary outcomes
1
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Description
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Mean Arterial Pressure
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Timepoint
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During Anesthesia
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Method of measurement
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Radial artery catheter
2
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Description
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Heart rate
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Timepoint
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During anesthesia
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Method of measurement
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Using a monitoring device
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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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.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Iran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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Information about the main outcome will be shared.
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When the data will become available and for how long
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Start the access period 6 months after printing the results.
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To whom data/document is available
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Data will only be available to researchers working in academic institutions.
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Under which criteria data/document could be used
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The documentation is for use in research projects only.
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From where data/document is obtainable
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Dr Sahar Masghati :saharmasghati@gmail.com
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What processes are involved for a request to access data/document
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To receive documentation, send email to Dr Sahar Masghati .Data will be sent within 3 months.
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Comments
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