Abstract:
Phenylephrine and Ephedrine for spinal anesthesia induced hypotention after elective orthopedic surgeries
Background
One of the most common complications of spinal anesthesia is hypotention, so there is no general agreement on the treatment of this event. The aim of this study is assessing and comparing of Phenylephrine and Ephedrine on treatment of hypotention after spinal anesthesia in orthopedic surgeries in Alzahra University Hospital in Isfahan in 2015.
Materials and Methods
In this double-blind clinical trial 110 patients undergoing elective orthopedic surgeries will be randomized into two groups. Patients receive 50μg Phenylephrine(group P), and 5mg ephedrine(group E); both intravenousely after observation of hypotension episode. We compare hemodynamic parameters (blood pressure, heart rate) and the incidence of hypotension and other complications and also total dose of vasoconstrictor used in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015070920588N3
Registration date:2015-11-12, 1394/08/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-11-12, 1394/08/21
Registrant information
Name
Darioush Moradi Farsani
Name of organization / entity
Isfahan Univesity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3625 5555
Email address
dmoradi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Research deputy of Isfahan University of Medical Scienses
Expected recruitment start date
2015-02-20, 1393/12/01
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
Comparison of Phenylephrine and Ephedrine in the treatment of hypotension after spinal anesthesia
Public title
Comparison of Phenylephrine and Ephedrine in the treatment of hypotension
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: 110 patient with ASA physical status class I-II aged 40-65 years who are candidates of lower extremity orthopedic surgery.
Exclusion criteria:Any hypersensitivity reaction to vasopressore or local anesthetic drugs, systemic diseases like cardiovascular, liver, or renal diseases and pregnancy.
Age
From 40 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Research Deputy, Isfahan university of medical sciences, Hezarjrib Street, Isfahan, Iran
City
Isfahan
Postal code
Approval date
2014-12-11, 1393/09/20
Ethics committee reference number
13625 /8/د
Health conditions studied
1
Description of health condition studied
Hypotension
ICD-10 code
195.2
ICD-10 code description
Hypotension due to drugs
Primary outcomes
1
Description
Systolic blood pressure
Timepoint
2, 4, 6, 8, 10, 14, 20 and 30 minutes after arrival of the patient to the recovery room.
Method of measurement
Noninvasive Blood pressure monitoring system
2
Description
Diastolic blood pressure
Timepoint
2, 4, 6, 8, 10, 14, 20 and 30 minutes after arrival of the patient to the recovery room.
Method of measurement
Noninvasive Blood pressure monitoring system
3
Description
Mean arterial blood pressure
Timepoint
2, 4, 6, 8, 10, 14, 20 and 30 minutes after arrival of the patient to the recovery room.
Method of measurement
Noninvasive Blood pressure monitoring system
Secondary outcomes
1
Description
Heart rate
Timepoint
2 ،4 ، 6 ، 8 ، 10 ، 14 ، 20 and 30 minutes after arrival of the patient to the recovery room
Method of measurement
pulse oxymetery
2
Description
Arterial blood oxygen saturation
Timepoint
2 ،4 ، 6 ، 8 ، 10 ، 14 ، 20 and 30 minutes after arrival of the patient to the recovery room
Method of measurement
pulse oxymetery
3
Description
Drug and non drug related complications
Timepoint
Any time during the study
Method of measurement
clinical evaluation
Intervention groups
1
Description
Intervention group-1 :Will receive 50μg Phenylephrine(group P) intravenousely after observation of hypotension episode(grater than %20 of baseline blood pressure) and in non responsive cases ephedrine will be infused and repeated till achieving normal blood pressure. If bradycardia develops (Heart rate bellow 60 beat per minute) 0.5 mg Atropine IV will be infused.
Category
Treatment - Drugs
2
Description
Intervention group-2 :Will receive 5mg Ephedrine(group E) intravenousely after observation of hypotension episode(grater than %20 of baseline blood pressure) and in non responsive cases ephedrine will be infused and repeated till achieving normal blood pressure. If bradycardia develops (Heart rate bellow 60 beat per minute) 0.5 mg Atropine IV will be infused.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Feiz University Hospital
Full name of responsible person
Dr Darioush Moradi Farsani
Street address
Feiz University Hospital, Soroush Street, Isfahan, Iran
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vce chancellor for research of Isfahan University of Medical Scienses
Full name of responsible person
dr Mehdi Nematbakhsh
Street address
Research daeputy, Isfahan University of Medical Sciences, Hezargrib Street, Isfahan, Iran
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vce chancellor for research of Isfahan University of Medical Scienses
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
Isfahan University of Medical Sciences
Full name of responsible person
Darioush Moradi
Position
Assistant Professor of Anesthesia and Critical care
Other areas of specialty/work
Street address
Depatment of Anesthesia and critical care, Alzahra University Hospital, Hezarjrib street, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3362 5555
Fax
Email
dmoradi@med.mui.ac.irdrdmoradi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Darioush Moradi
Position
Assistant Professor of Anesthesia and Critical Care
Other areas of specialty/work
Street address
Depatment of Anesthesia and critical care, Alzahra University Hospital, Hezarjrib street, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3362 5555
Fax
Email
dmoradi@med.mui.ac.irdrdmorsdi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Scienses
Full name of responsible person
Darioush Moradi
Position
Assisstant Professor of Anesthesia and Critical Care
Other areas of specialty/work
Street address
Depatment of Anesthesia and critical care, Alzahra University Hospital, Hezarjrib street, Isfahan esthesia and critical care
City
Isfahan
Postal code
8174675731
Phone
+98 31 3362 5555
Fax
+98 31 3668 4510
Email
dmoradi@med.mui.ac.irdrdmoradi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)