Comparison between different prophylactic & therapeutic phenylephrine regimenes in reducing maternal hypotention after induction of spinal anesthesia in caesarean section
1)Objectives: hypotension remains the most common complication of spinal anesthesia in cesarean section. A lot of studies have been performed to solve this problem but there are still controversies. This investigation was planned to find the best dose and the best way of phenylephrine administration to reduce the incidence of spinal anesthesia induced hypotension in cesarean section.
2) Design: 120 patients will be studied in 3 groups. Groups 1 & 2 will receive prophylactic 100 microgram bolus dose or 50 µg /min infusion of phenylephrine immediately after spinal anesthesia and the third group (placebo) will receive normal saline.
3) Setting & conduct:all of the drugs will be prepared in the same syringes with the same volume. The patient and the nurse who recorded the vital signs are not aware of the grouping. Patient’s blood pressure will be measured by non invasive blood pressure monitoring and will be recorded. In the case of hypotension which was defined as more than 20% decline in blood pressure compared to baseline, 100 µg phenylephrine in one ml volume will be injected in all three groups and if hypertension was detected, the infusing solution will be hold.
4): Participants including major eligibility criteria: all of the ASA 1 healthy term parturients referring to Fatemieh hospital candidate for Cesarean section will be included in the study.
Exclusion criteria: chronic hypertension; preeclampsia; twin pregnancy;, preterm labor; allergy to drugs; cardiovascular disease; renal disease and previous abdominal surgeries with adhesion band and fibrosis.
5) Intervention: prophylactic bolus dose administration or infusion of phenylephrine 6) Main outcome measures variables:spinal anesthesia induced blood pressure change
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201601238768N4
Registration date:2016-10-09, 1395/07/18
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-10-09, 1395/07/18
Registrant information
Name
Mahshid Nikooseresht
Name of organization / entity
Hamadan university of Medical Sciences, Faculty of Medicine
Country
Iran (Islamic Republic of)
Phone
+98 81 3823 5383
Email address
nikooseresht@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research and Technology, Hamadan University Of Medical Sciences
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2017-08-20, 1396/05/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between different prophylactic & therapeutic phenylephrine regimenes in reducing maternal hypotention after induction of spinal anesthesia in caesarean section
Public title
Evaluation of the effect of phenylephrine on spinal anesthesia induced hypotension in cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All of the ASA 1 healthy term parturients referring to Fatemieh hospital candidate for Cesarean section were included in the study.
Exclusion criteria: chronic hypertension; pre eclampsia; twin pregnancy;, preterm labor; allergy to drugs; cardiovascular disease; renal disease and previous abdominal surgeries with adhesion band and fibrosis.
Age
From 16 years old to 50 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
120
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
Committee of Ethics in Research, Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Street, Hamadan
City
Hamedan
Postal code
65178
Approval date
2016-01-23, 1394/11/03
Ethics committee reference number
IR.UMSHA.REC.1394.449
Health conditions studied
1
Description of health condition studied
spinal anesthesia induced 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
spinal anesthesia induced blood pressure change
Timepoint
before performing spinal anesthesia, every 2 minutes until delivery and then every 5 minutes until the end of surgery
Method of measurement
blood pressure was measured with automatic blood pressure device and hypotension was defined as more than 20% decrease of BP compared to baseline
Secondary outcomes
1
Description
Heart rate
Timepoint
before performing spinal anesthesia and then every 5 minutes until the end of surgery
Method of measurement
Electrocardiogram monitoring
2
Description
nausea
Timepoint
every 5 minutes until the end of surgery
Method of measurement
observation
3
Description
vomiting
Timepoint
every 5 minutes until the end of surgery
Method of measurement
observation
4
Description
rescue vasopressor dose
Timepoint
at the end of surgery
Method of measurement
measurement
5
Description
Neonatal condition
Timepoint
at min 1 and 5
Method of measurement
Apgar score mesurements by observation and physical examination
Intervention groups
1
Description
Intervention1: after performing spinal anesthesia (with 10 milligram bupivacaine plus 25 micro-gram fentanyl) 100 microgram phenylephrin in 1 cc volume will be injected and then infusion of normal saline will be started and continued until delivery. In the case of hypotension 50 microgram phenylephrine will be injected.
Category
Treatment - Drugs
2
Description
Intervention 2: after performing spinal anesthesia (with 10 milligram bupivacaine plus 25 micro-gram fentanyl) normal saline in 1 cc volume will be injected and then infusion of phenylephrine 50 microgram per minute will be started and continued until delivery. In the case of hypotension 50 microgram phenylephrine will be injected.
Category
Treatment - Drugs
3
Description
Control group: after performing spinal anesthesia (with 10 milligram bupivacaine plus 25 micro-gram fentanyl) normal saline in 1 cc volume will be injected and then infusion of normal saline will be started and continued until delivery. In the case of hypotension 50 microgram phenylephrine will be injected.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh hospital
Full name of responsible person
Mahshid Nikooseresht
Street address
Pasdaran Street, Shariati square, Hamadan, Iran
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research and Technology, Hamadan University Of Medical Sciences
Full name of responsible person
Saiid Bashirian
Street address
Hamadan University of Medical Science, Shahid Fahmideh street, Hamadan
City
Hamadan
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 and Technology, Hamadan 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
Hamadan University of Medical Sciences
Full name of responsible person
Mahshid Nikooseresht M.D
Position
Assistant Professor of Anesthsiology, Fellowship of Pain managenent