This investigation is designed as a unicenter, phase 2-3 clinical trial. 105 single fetus pregnant women who are candidate for elective cesarean, 18 to 40 years old, ASA class I-II with systolic blood pressure 120-140 mmhg will enter the trial. In all patients anesthetic approach is spinal block with bupivacaine 0.5%. In patients with hypotention that need to treat with vasopressor,
randomly phenylephrine or ephedrine will prescribed. Changes of blood pressure, heart rate, type and amount of vasopressor and severity of headache (visual analogue scale) is measured and recorded by anesthesia nurse who will blind with the type of the group and vasopressor.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201509042946N7
Registration date:2016-12-07, 1395/09/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-12-07, 1395/09/17
Registrant information
Name
Mitra Yari
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 6310
Email address
myari@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2016-08-21, 1395/05/31
Expected recruitment end date
2017-02-18, 1395/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of headache prevalence and intensity following administration of ephedrine and phenylephrine in cesarean section under spinal anesthesia
Public title
comparison of headache accurance and severity after use of phenylephtine and ephedrine for treatment of hypotention during cesarian delivery under spinal anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Pregnant women aged 18 to 40 years; ASA class I_II; systolic blood pressure 120-140 mmhg; body mass index 18.5_25 and normal single fetus pregnancy.
Exclusion criteria: History of migraine; psychiatric disorders; any medication except pregnancy supplements; presence of headache in admission time to operation room; eclampsia; preeclampsia; hypertention; diabetes mellitus and cardiovascular disease.
Age
From 18 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Drug prepration will done by an anesthetic nurse. Drug prescription will done by second and evaluation of accurance and severity of headache will done by third nurse. All of nurses and patientswill blinded with type of vasopressor. Randomization will done in allocation of patients to two drug groups(phenylephrine and ephedrine).
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of Kermanshah University of Medical Sciences
Street address
No. 2 building of Medical University, Shahid Beheshti boulevard
City
kermanshah
Postal code
00988334276310
Approval date
2015-08-18, 1394/05/27
Ethics committee reference number
KUMS.REC.1394.52
Health conditions studied
1
Description of health condition studied
headache
ICD-10 code
G44.4
ICD-10 code description
Drug-induced headache, not elsewhere classified
Primary outcomes
1
Description
headache incidence and intencity
Timepoint
during cesarean, 1, 6, 24 hours later
Method of measurement
by visual analogue scale
Secondary outcomes
1
Description
vital sign changes
Timepoint
every 2 minute until 10minute then every 5 minute
Method of measurement
by datascope monitor
Intervention groups
1
Description
Ephedrine ampule 10 mcgr, Intravenous, repeated until hemodynamic stability
Category
Prevention
2
Description
Phenylephrine ampule 50 mcgr, Intravenous, repeated until hemodynamic stability in the first case group
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr. Mitra Yari
Street address
Parastar boulevard, Sorkhalijeh
City
kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for reasearch ,Kermanshah University of Medical Sciences