Hypotension, a frequent complication of spinal anesthesia for caesarean delivery, can have adverse maternal and fetal effects. Single-agent prophylaxis, most notably with ephedrine, does not reliably prevent spinal anesthesia-induced hypotension. The aim of this study is evaluate the effect of prophylactic infusion of ephedrine and phenylephrine combination on maternal hemodynamics after spinal anesthesia for cesarean section. In this double-blind, randomized, and placebo-controlled clinical trial, 90 parturients undergoing spinal anesthesia for elective cesarean delivery were randomized to receive an prophylactic IV infusion of phenylephrine and ephedrine combined in the study group (n=45) or normal saline in the placebo group (n=45) from 15 minutes before the start of spinal block. The infusions are adjusted to maintain systolic blood pressure (SBP) near baseline until induction of anesthesia. Hemodynamic changes, total consumption of vasoconstrictors, and umbilical cord blood gases are compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201401277013N6
Registration date:2014-02-10, 1392/11/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-02-10, 1392/11/21
Registrant information
Name
Simin Atashkhoei
Name of organization / entity
Tabriz University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 41 3333 3806
Email address
atashkhoii@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chanceller for Research, Tabriz University of Medical Sciences
Expected recruitment start date
2013-11-03, 1392/08/12
Expected recruitment end date
2014-08-02, 1393/05/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Prophylactic Infusion of Ephedrine and Phenylephrine Combination on Maternal Hemodynamics after Spinal Anesthesia for Cesarean section
Public title
Effect of prophylactic of ephedrine and phenylephrine combination in control of maternal hypotension after spinal anesthesia for cesarean section
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: term pregnancy; aged 18-40 years; ASA class I or II; scheduled for Cesarean section; scheduled for spinal anesthesia.
Exclusion criteria: contraindication for spinal anesthesia; allergy to local anesthetics; Organic dysfunction (cardiovascular; cardiovascular disease,...) fetal abnormalities; maternal hypertension; chronic medication abuse
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Vice Chancellor of Tabriz University of Medical Sciences
Street address
Research Vice Chanceller; Tabriz University; Daneshgah Street; Tabriz
City
Tabriz
Postal code
Approval date
2013-11-03, 1392/08/12
Ethics committee reference number
92115
Health conditions studied
1
Description of health condition studied
Hypotension after spinal anesthesia
ICD-10 code
I95.2
ICD-10 code description
Hypotension due to drugs
Primary outcomes
1
Description
Blood pressure
Timepoint
Baseline and every 2 minutes after start of study solusion infusion
Method of measurement
mmHg
Secondary outcomes
1
Description
Total dose of vasoconstrictors
Timepoint
After spinal anesthesia to end of operation
Method of measurement
Doses of medicatins by mg or ug
Intervention groups
1
Description
In the study group(n=45) ephedrine 10mg plus phenylephrine 125 ug into 15 ml normal saline at rate of 60 ml/h (within 15 min) is infused.
Category
Prevention
2
Description
In the placebo group(n=45) 15 ml normal saline at rate of 60 ml/h (within 15 min) is infused.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Dr.Simin Atashkhoii
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Tabriz University of Medicalُ Sciences
Full name of responsible person
Dr. Rashidi
Street address
Research Vice Chancellor; Daneshgah Street; Tabriz
City
TABRIZ
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, Tabriz University of Medicalُ Sciences
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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Simin Atashkhoyi
Position
Anesthesiologist/ Professor
Other areas of specialty/work
Street address
Al-Zahra Hospital; South Artesh street; Tabriz
City
Tabriz
Postal code
Phone
+98 41 1553 9161
Fax
Email
satashkhoyi@gmail.comsiminatashkhoii@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Simin Atashkhoyi
Position
Anesthesiologist/Professor
Other areas of specialty/work
Street address
Al-Zahra Hospital; South Artesh street; Tabriz
City
Tabriz
Postal code
Phone
+98 41 1553 9161
Fax
Email
satashkhoyi@gmail.comsiminatashkhoii@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Simin Atashkhoyi
Position
Anesthesiologist/Professor
Other areas of specialty/work
Street address
Al-Zahra Hospital; South Artesh street; Tabriz
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)