this investigation was planned to evaluate the effect of lower limb elevation to reduce the incidence of spinal anesthesia induced hypotension in cesarean section.
Design
Design: This is a two arm parallel group randomised clinical trial with blinded postoperative care and outcome assessment in which 110 patients will be studied in 2 groups.
Settings and conduct
This investigation will be performed in Fatemieh Hospital, Hamadan. The person who care the patients and the person who analyze the data are blinded to group stratification. After performing spinal anesthesia in sitting position; immediately the patient will be placed in supine or supine with leg elevation position. Non invasive blood pressure monitor, ECG and pulse oximetry will be used for monitoring of vital signs every 2 minutes until delivery and then every 5 minutes until the end of the surgery.
Participants/Inclusion and exclusion criteria
Inclusion criteria: all of the ASA 1 (18-45yr )healthy term parturients candidate for Cesarean section
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
Intervention groups
Intervention group: Immediately after spinal anesthesia injection and in supine position, a wedge with the height of 30 cm was inserted below the patient ankles to place the patients hip in 30 degree semiflexed position and remained in this position until the skin incision and then it was removed.
control group: Patient was placed in supine position with no wedge under the ankles.
Main outcome variables
Blood pressure changes after spinal anesthesia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120118008768N8
Registration date:2018-11-06, 1397/08/15
Registration timing:prospective
Last update:2018-11-06, 1397/08/15
Update count:0
Registration date
2018-11-06, 1397/08/15
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
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-07-22, 1398/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of lower limb elevation in prevention of spinal anesthesia- induced maternal hypotension in elective cesarean section
Public title
The effect of leg elevation on hypotension after spinal anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All of the ASA 1 aged 18-45 yr healthy parturients
Single tone term parturients
Referred to Fatemieh hospital for elective Cesarean section
Exclusion criteria:
Exclusion criteria: chronic hypertension; ; ;, ; allergy to drugs; ; renal disease and
pre eclampsia
twin pregnancy
preterm labor
allergy to drugs
cardiovascular and pulmonary disease
Renal Disease
previous abdominal surgeries with adhesion band and fibrosis.
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization with sealed envelope
For this purpose 4 papers were prepared. The letter "I" for Internention was written on 2 papers and the letter "C" for Comparison was written on two another papers. All 4 sheets were placed in a drawer and for including each patient one sheet was pulled out. According to the letter on the sheet "I" or "C"; the patient was assigned to intervention (leg elevation) or control (supine position) group. All of the four sheets were re-turned to the drawer and this cycle will be continued to meet the calculated sample size.
Blinding (investigator's opinion)
Single blinded
Blinding description
The person who collects data, Data Safety and Monitoring Committee and also the person who analyzes the data are blinded.
Placebo
Not 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
Hamadan
Province
Hamadan
Postal code
65178
Approval date
2017-10-14, 1396/07/22
Ethics committee reference number
IR.UMSHA.REC.1396.494
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
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 after birth
Method of measurement
Apgar score measurements by observation and physical examination
Intervention groups
1
Description
Intervention group: Immediately after spinal anesthesia injection, a wedge with 30 cm height will be inserted under both ankles until skin incision.
Category
Prevention
2
Description
Control group: Immediately after spinal anesthesia, the patients will be placed in supine position.
Category
Prevention
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
Province
Hamadan
Postal code
6516833333
Phone
+98 81 3827 6055
Email
nikooseresht@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saiid Bashirian
Street address
Hamadan University of Medical Science, Shahid Fahmideh street, Hamadan
City
Hamadan
Province
Hamadan
Postal code
65178
Phone
+98 81 3838 0717
Fax
+98 81 3838 0130
Email
nikooseresht@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mahshid Nikooseresht
Position
Associate Professor of Anesthsiology, Fellowship of Pain managenent