Comparison of the effects of ephedrine, atropine and mucosal phenylephrine perfusion in preventing hypotension during spinal anesthesia for ceasarean section.
Occurrence of hypotension after spinal anaesthesia is common. This study aims to find the most effective way of preventing hypotension that occurs after spinal anaesthesia and its subsequent complications. Preventing the hypotension associated with spinal anaesthesia could produce a better condition for the operation and surgery could be done with less end organ damage and higher safety level. Materials and Methods: This is a randomized double blind prospective study with 3 groups. Ninety young adult female, ASA physical status 1 and 11 with single pregnancy undergoing elective caesarean section under spinal anaesthesia divided into 3groups. All of the groups will receive 500 ml ringer serum before spinal anaesthesia. The first group will receive 0.5 mg atropine (IV), the second group will receive 5mg ephedrine and the last group will receive 100µgr phenylephrine (mucosal). Blood pressure, heart rate, oxygen saturation and side effects were recorded before spinal anaesthesia, and every 5 minutes throughout the operation up to 30 minutes. After that recordings will be at 15 minutes interval until 1.5 hours after spinal anaesthesia. If systolic blood pressure comes to less than 80 mmHg we will get the patients 5 mg ephedrine. Key Words: Anaesthesia, Caesarean, Prophylaxis, Atropine, Ephedrine, phenylephrine
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138902213912N1
Registration date:2010-06-15, 1389/03/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-06-15, 1389/03/25
Registrant information
Name
Kobra Nourian
Name of organization / entity
Sharekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1333 5648
Email address
noorian@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahrekord University of Medical Sciences
Expected recruitment start date
2006-12-22, 1385/10/01
Expected recruitment end date
2007-05-22, 1386/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of ephedrine, atropine and mucosal phenylephrine perfusion in preventing hypotension during spinal anesthesia for ceasarean section.
Public title
Comparison of the effects of ephedrine, atropine and mucosal phenylephrine perfusion in preventing hypotension during spinal anesthesia for ceasarean section.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria consisted of age between 20-40 years, ASAphysical status 1 and 11, single pregnancy, elective ceasarean, gestational age≥37weeks and patients satisfaction.
Exclusion criteria consisted of hypovolemia, deformity of spinal column, increase of ICP, coaglopathy, infection of skin or soft tissue and unsatisfaction of patient .
Age
From 20 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
Not used
Assignment
Parallel
Other design features
This is a double blind study because both the patients and the officer responsible for measuring outcomes are unaware of the intervention received by patient.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahrekord University of Medical Sciences
Street address
Shahrekord -kashane street-university of medical sciences
City
Shahrekord
Postal code
8813833435
Approval date
empty
Ethics committee reference number
86-312
Health conditions studied
1
Description of health condition studied
Single delivery ceasarean
ICD-10 code
O82.0
ICD-10 code description
Single delivery by caesarean section
Primary outcomes
1
Description
blood pressure
Timepoint
before spinal anesthesia andevery 5 minutes interval through out the surgery until 30 minutes,therefore at 15minutes interval until 1.5 hourrs after spinal
Method of measurement
palseoxymetery
2
Description
heart rate
Timepoint
before spinal anesthesia andevery 5 minutes interval through out the surgery until 30 minutes,therefore at 15minutes interval until 1.5 hourrs after spinal
Method of measurement
palseoxymetery
3
Description
oxygen saturation
Timepoint
before spinal anesthesia andevery 5 minutes interval through out the surgery until 30 minutes,therefore at 15minutes interval until 1.5 hourrs after spinal
Method of measurement
palse oxymetery
Secondary outcomes
empty
Intervention groups
1
Description
0.5 mg atropine (IV) before spinal anesthesia (single dose)
Category
Treatment - Drugs
2
Description
5mg ephedrine before spinal anesthesia(single dose)
Category
Treatment - Drugs
3
Description
100µgr phenylephrine (mucosal) before spinal anesthesia (single dose)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajar Hospital
Full name of responsible person
Mitra Talebpoor
Street address
Parastar Street-Hajar Hospital-Surgery Department
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Reserch Center
Street address
Kashani Street.University of Medical Sciences
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrekord University of Medical 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
Shahrekord University of Medical Sciences
Full name of responsible person
Cobra Noorian
Position
Lecturer, Nursing Dept, Shahrekord University of Medical Sciences
Other areas of specialty/work
Street address
Nursing department, Shahrekord University of Medical Sciences
City
Shahrekord
Postal code
8813833435
Phone
+98 38 1333 5648
Fax
+98 38 1334 6714
Email
noorian@skums.ac.ir; cobranori@yahoo.com
Web page address
www.skums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Mohammmad Reza Abedinzadeh
Position
Assistant Proffesr
Other areas of specialty/work
Street address
Assistant proffesr, Anesthesiology Dept, Shahrekord University of Medical Sciences
City
shahrekord
Postal code
8815713471
Phone
+98 38 1333 5552
Fax
+98 38 1334 6714
Email
abedinzade@skums.ac.ir
Web page address
www.skums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Cobra Noorian
Position
Lecturer, Nursing Dept, Shahrekord University of Medical Sciences
Other areas of specialty/work
Street address
Rahmateieh- Shahrekord University of Medical Sciences
City
Shahrekord
Postal code
8813833435
Phone
+98 38 1333 5648
Fax
+98 38 1334 6714
Email
noorian@skums.ac.ir
Web page address
www.skums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)