Comparison between the effect of Phenylephrine versus Ephedrine on treatment of maternal hypotension & neonatal cord Venus blood analysis during caesarean section under spinal anesthesia with Bupivacaine
The purpose of this study is comparison of Phenylephrine and Ephedrine on treatment of maternal hypotension and neonatal cord blood Gases analysis during caesarean section under spinal anesthesia with Bupivacaine.This study undergoing on 100 singleton pregnant women with gestational age of 37 weeks that are undergoing to spinal anesthesia with Bupivacaine for cesarean section. Patients are randomly divided into two groups P and E. Before spinal anesthesia both groups receive 500 ml Ringer. The arterial blood pressure, heart rate and blood oxygen saturation be measure and use as a basis. Three mL of 0.5% Hyperbaric Bupivacaine is injected in vertebral space L4-L5 in both groups. Immediately after spinal anesthesia, then every 5 minutes until 30 minutes and every 10 minutes until reduced sensation below the level of T10, arterial blood pressure, heart rate and blood oxygen saturation will be measured and recorded. If hypotension is more than 20% from baseline or a systolic blood pressure less than 100, 100 micro gram bolus Phenylephrine or 10 mg ephedrine inject. Bolus doses repeat if necessary. After the neonates delivery, the"1st and 5th minutes' Apgar scores" is recorded and umbilical venous blood samples are taken to evaluate acid-base status.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201412046280N5
Registration date:2014-12-17, 1393/09/26
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-12-17, 1393/09/26
Registrant information
Name
Mohammad Haghighi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3211 1319
Email address
mohaghighi@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan university of medical sciences
Expected recruitment start date
2015-01-20, 1393/10/30
Expected recruitment end date
2015-04-30, 1394/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between the effect of Phenylephrine versus Ephedrine on treatment of maternal hypotension & neonatal cord Venus blood analysis during caesarean section under spinal anesthesia with Bupivacaine
Public title
Effect of phenylephrine and ephedrine for treatment of hypotension during Caesarean
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Age 18-40 years; MOM height 150-170 cm; Weight 60-90 kg; Gestational age 37-42 weeks; Singleton; ASA class 1, 2; Systolic blood pressure under 100 mmHg after spinal anesthesia
Exclusion criteria:
Severe respiratory distress; Cord prolapse; Decollement;
Placenta prevail
Age
From 18 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
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
Ethics committee of Guilan university of Medical Science
Street address
Namjoo Street
City
Rasht
Postal code
4193893345
Approval date
2014-09-30, 1393/07/08
Ethics committee reference number
1930330303
Health conditions studied
1
Description of health condition studied
Maternal hypotension
ICD-10 code
O26.5
ICD-10 code description
Maternal hypotension
Primary outcomes
1
Description
Blood pressure
Timepoint
After spinal anesthesia, then every 5 minutes until 30 minutes and every 10 minutes until reduced sensation below the level of T10
Method of measurement
mmHg by Saadat monitoring system
2
Description
Oxygen saturation
Timepoint
Upon arrival to operating room , 3, 5, 10, 15 minutes after endotracheal intubatioin and 10 minutes after extubation
Method of measurement
Percent by pulse oximeter
3
Description
PH umblical vein
Timepoint
After birth
Method of measurement
by AVL
4
Description
Neonate APgar
Timepoint
First and five minutes after birth
Method of measurement
Apgar score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention1: Injection 100 micro ggram phenylephrine if hypotension is more than 20% from baseline or a systolic blood pressure less than 100
Category
Treatment - Drugs
2
Description
Intervention 2: Injection 10 mg ephedrine if hypotension is more than 20% from baseline or a systolic blood pressure less than 100
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Mohammad Haghighi
Street address
Namjoo Street
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Guilan University of Medical Sciences
Full name of responsible person
Abtin Heidarzadeh
Street address
Shahid beheshti Highway
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Guilan University of Medical Sciences
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Full name of responsible person
Street address
City
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Proportion provided by this source
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
Guilan University of Medical Sciences
Full name of responsible person
Mohammad Haghighi
Position
Anesthesiologist/ Associated Professor
Other areas of specialty/work
Street address
PoorsinaHospital
City
Rasht
Postal code
4193713194
Phone
+98 13 3331 0434
Fax
+98 13 3334 5132
Email
arcguilan1392@gmail.com
Web page address
www.arc.gums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Mohammad Haghighi
Position
Anesthesiologist/Assosiated proffessor
Other areas of specialty/work
Street address
Poursina Hospital
City
Rasht
Postal code
4139638459
Phone
+98 13 3331 0434
Fax
+98 13 3334 5132
Email
arcguilan1392@gmail.com
Web page address
www.arc.gums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Hedieh Nemati
Position
Medical laboratory Sciences Technician/ Bachelor's Degree
Other areas of specialty/work
Street address
Poursina Hospital
City
Rasht
Postal code
4193713194
Phone
+98 13 3331 0434
Fax
+98 13 3334 5132
Email
arcguilan1392@gmail.com
Web page address
www.arc.gums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)