Protocol summary

Study aim
Comparison of intravenous injection of phenylephrine and ephedrine in preventing post spinal hypotension in cesarean section
Design
80 patients were randomly assigned to a double blind randomized phase 4 clinical trial. They are randomly placed in 4 blocks and enter into one of two ephedrine (A) and phenylephrine (B) groups.
Settings and conduct
After spinal anesthesia in candidates for C/S in Fatemieh hospital of Hamedan, they are placed in a supine position and in one of two groups A (10 mg ephedrine) or B (100 μg phenylephrine) .Both medicines are prepared by an anesthetist nurse who does not have information from the groups in syringes of the same shape and volume, and injected intravenously, in which anesthetist and patient are not familiar with the type of medication prescribed
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients aged 18 to 45; healthy and candidates for C/S under spinal anesthesia. Exclusion criteria: Cardiac disease; Renal disease; Hypertension; Diabetes; Eclampsia and pre-eclampsia; Multiple pregnancy; Candidates for emegency C/S and spinal anesthesia contraindications.
Intervention groups
Patients were restored to supine position after spinal anesthesia and in group A 10 mg ephedrine and group B 100 microgram phenylephrine, is prepared with the same shape and volume, by an anesthetist nurse and is injected intravenously.
Main outcome variables
Systolic; Diastolic blood pressure; Mean arterial pressure; heart rate and SPO2 in 0, 2, 4, 6, 8, 10, 15, 20, 25, 30, 40, 50, 60 minutes; nausea and vomiting; first and fifth minutes Apgar score and consum ephedrine and atropine are registered.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120915010841N8
Registration date: 2018-06-23, 1397/04/02
Registration timing: registered_while_recruiting

Last update: 2018-06-23, 1397/04/02
Update count: 0
Registration date
2018-06-23, 1397/04/02
Registrant information
Name
Nahid Manuchehrian
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 7012
Email address
manouchehrian@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2018-07-23, 1397/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Intravenous bolus Phenylephrine and Ephedrine for prevention of postspinal Hypotension during Cesarean section.
Public title
Determination of effective drug in prevention of post spinal hypotension in C/S
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
ASA CLASS 1(Healthy Patients) 18-45 aged pregnant patients for C/S
Exclusion criteria:
Cardiac disease Renal disease History of hypertensive disease Diabetes Eclampsia &pre eclampsia Multiple pregnancy C/S for meconium or fetal distress Contraindications for spinal anesthesia
Age
From 18 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the randomization method is used as a 4-blocks. In this way, according to the sample size, 20 blocks of four are identified, and in each of these blocks of four, two of each group will be written in the form of letters A or B. This means that two A and two B are written in each block, although the order of the writing of the four letters A and B will be different in each block. The periodic numbers table will then be used to determine the order of block selection.
Blinding (investigator's opinion)
Double blinded
Blinding description
Ephedrine (10 mg) and phenylephrine (100 μg) in the same volumes (1 ml) are prepared in the same syringes by the anesthetist nurse according to the list of patients entered into the study (based on the four blocks) and then administered intravenously after spinal anesthesia. . Therefore, the anesthetist, the patient and the person evaluating the outcome (anesthetist) are not familiar with the type of prescribed medication
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Hamadan university of Medical Sciences
Street address
Fahmide Street
City
Hamadan
Province
Hamadan
Postal code
6517838678
Approval date
2017-11-25, 1396/09/04
Ethics committee reference number
IR.UMSHA.REC.1396.580

Health conditions studied

1

Description of health condition studied
post spinal anaesthesia hypotension
ICD-10 code
O74.6
ICD-10 code description
Other complications of spinal and epidural anaesthesia during labour and delivery

Primary outcomes

1

Description
Systolic blood pressure
Timepoint
Minutes of 0,2, 4, 6, 8, 10,15, 20, 25, 30, 40, 50 and 60 after spinal anesthesia
Method of measurement
Automatic non-invasive blood pressure device

2

Description
Diastolic blood pressure
Timepoint
Minutes of 0,2, 4, 6, 8, 10,15, 20, 25, 30, 40, 50 and 60 after spinal anesthesia
Method of measurement
Automatic non-invasive blood pressure device

3

Description
Mean arterial pressure
Timepoint
Minutes of 0,2, 4, 6, 8, 10,15, 20, 25, 30, 40, 50 and 60 after spinal anesthesia
Method of measurement
Automatic non-invasive blood pressure device

Secondary outcomes

1

Description
Heart rate
Timepoint
Minutes of 0,2, 4, 6, 8, 10,15, 20, 25, 30, 40, 50 and 60 after spinal anesthesia.
Method of measurement
Pulse oximetry device

2

Description
Arterial oxygen saturation
Timepoint
Minutes of 0,2, 4, 6, 8, 10,15, 20, 25, 30, 40, 50 and 60 after spinal anesthesia.
Method of measurement
Pulse oximetry device

3

Description
Nausea and vomiting
Timepoint
During surgery
Method of measurement
Observation

4

Description
Apgar Score of neonate
Timepoint
The first and fifth minutes after birth
Method of measurement
Examination and calculation on Apgar score

5

Description
The amount of ephedrine have been consumed
Timepoint
during surgery
Method of measurement
The amount of ephedrine have been consumed by mg

6

Description
The amount of atropine have been consumed
Timepoint
during surgery
Method of measurement
The amount of atropine have been consumed by mg

Intervention groups

1

Description
First intervention group : In this group immediately after the spinal anesthesia, 10 mg (1ml) of ephedrine which is a vaoconstrictor for prevetion of hypotension is injected intravenously.
Category
Prevention

2

Description
Second intervention group : In this group immediately after the spinal anesthesia, 100 ug (1ml) of ephedrine which is a vaoconstrictor for prevetion of hypotension is injected intravenously.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Nahid Manouchehrian
Street address
Fatemieh Hospital, Pasdaran Street.
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7012
Fax
+98 81 3828 3939
Email
hp.fatemieh@gmail.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeed Bashirian
Street address
Fahmieh Street, Hamadan university of medical sciences
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3838 0717
Fax
+98 81 3838 0130
Email
VC_research@umsha.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Hamedan University of Medical Sciences, vice chancellor of research
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
Hamedan University of Medical Sciences
Full name of responsible person
Nahid Manouchehrian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Fatemieh Hospital, Pasdaran Street.
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7012
Fax
+98 81 3828 3939
Email
manouchehrian@umsha.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Nahid Manouchehrian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Fatemieh Hospital, Pasdaran Street.
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7012
Fax
+98 81 3828 3939
Email
manouchehrian@umsha.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Nahid Manouchehrian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Fatemieh Hospital, Pasdaran Street.
City
Hamadan
Province
Hamadan
Postal code
6517789971
Phone
+98 81 3827 7012
Fax
+98 81 3828 3939
Email
manouchehrian@umsha.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
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