Back to resultsLeg Elevation for Prevention of Post Spinal Hypotension in Cesarean Section
Primary Purpose
Effects of; Anesthesia, Spinal and Epidural, in Pregnancy
Status
Unknown status
Phase
Not Applicable
Locations
Tunisia
Study Type
Interventional
Intervention
leg elevation
Sponsored by
About this trial
This is an interventional prevention trial for Effects of; Anesthesia, Spinal and Epidural, in Pregnancy
Eligibility Criteria
Inclusion Criteria:
- full term parturients
- age> 18 Y
- scheduled of elective or urgent cesarean section under spinal anesthesia
Exclusion Criteria:
- patients who had general anesthesia
Sites / Locations
- Mongi Slim HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
LE: leg elevation group
CG: Control group
Arm Description
the patients of this group will be positionned in supine with 15° left tilt and will have a leg elevation with a 30 cm pillow positionned under the heels. this position will be hold immediately after spinal anesthesia until fetal extraction
The patients of this group will be positiooned in supine with 15° left tlit after spinal anesthesia. no leg elevation
Outcomes
Primary Outcome Measures
Incidence of post spinal hypotension
change of systolic blood pressure from baseline< 90 mmHg
Secondary Outcome Measures
Lowest systolic blood pressure
the lowest systolic blood pressure observed after spinal anesthesia
ephedrine consumption
total dose of Ephedrine received to treat post spinal hypotension
Fetal ph
fetal ph measured with blood gas analysis
Fetal blood lactates
fetal blood lactates (mmol/L) measured with blood gas analysis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03488277
Brief Title
Leg Elevation for Prevention of Post Spinal Hypotension in Cesarean Section
Official Title
Evaluation of the Efficiency of Leg Elevation for Preventing Post Spinal Hypotension in Cesarean Section
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 10, 2018 (Actual)
Primary Completion Date
March 22, 2018 (Actual)
Study Completion Date
December 31, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mongi Slim Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Prospective trial including full term parturients scheduled for a cesarean section under spinal anesthesia. patients are being randomly assigned into 2 groups:
LE group: will be positioned in 15° left tilt with leg elevation with a 30cm height pillow under the heels, this position will be hold after spinal anesthesia until fetal extraction.
Control group: will be positioned in supine with 15° left tilt. the 2 groups will receive a 10ml/kg of crystalloid co-load intravenously, and the spinal anesthesia will be performed in sitting position with the same dose of Bupivacain, morphine and sufentanil.
Detailed Description
Prospective trial including full term parturients scheduled for a cesarean section under spinal anesthesia. patients are being randomly assigned into 2 groups:
LE group: will be positioned in 15° left tilt with leg elevation with a 30cm height pillow under the heels, this position will be hold after spinal anesthesia until fetal extraction.
Control group: will be positioned in supine with 15° left tilt. the 2 groups will receive a 10ml/kg of crystalloid co-load intravenously, and the spinal anesthesia will be performed in sitting position with the same dose of Bupivacain, morphine and sufentanil. we will record the demographic data, pre and intraoperative hemodynamic parameters, the dose of ephedrine required to treat post spinal hypotension and fetal parameters: pH and blood lactates
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Effects of; Anesthesia, Spinal and Epidural, in Pregnancy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
LE: leg elevation group
Arm Type
Experimental
Arm Description
the patients of this group will be positionned in supine with 15° left tilt and will have a leg elevation with a 30 cm pillow positionned under the heels. this position will be hold immediately after spinal anesthesia until fetal extraction
Arm Title
CG: Control group
Arm Type
No Intervention
Arm Description
The patients of this group will be positiooned in supine with 15° left tlit after spinal anesthesia. no leg elevation
Intervention Type
Other
Intervention Name(s)
leg elevation
Intervention Description
intra operative position that consists in leg elevation with a 30 cm height pillow under the patient's heels
Primary Outcome Measure Information:
Title
Incidence of post spinal hypotension
Description
change of systolic blood pressure from baseline< 90 mmHg
Time Frame
during the first 30minutes after the spinal anesthesia
Secondary Outcome Measure Information:
Title
Lowest systolic blood pressure
Description
the lowest systolic blood pressure observed after spinal anesthesia
Time Frame
during the first 30 minutes following spinal anesthesia
Title
ephedrine consumption
Description
total dose of Ephedrine received to treat post spinal hypotension
Time Frame
during the first 30 minutes following the spinal anesthesia
Title
Fetal ph
Description
fetal ph measured with blood gas analysis
Time Frame
30 minutes after spinal anesthesia
Title
Fetal blood lactates
Description
fetal blood lactates (mmol/L) measured with blood gas analysis
Time Frame
30 minutes after spinal anesthesia
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
full term parturients
age> 18 Y
scheduled of elective or urgent cesarean section under spinal anesthesia
Exclusion Criteria:
patients who had general anesthesia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mhamed Sami Mebazaa, professor
Phone
0021622252589
Email
msmebazaa@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Asma Ben Souissi
Phone
0021698336883
Email
bsouissiasma@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mhamed Sami Mebazaa, Professor
Organizational Affiliation
Mongi Slim Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mongi Slim Hospital
City
La Marsa
State/Province
Tunis
ZIP/Postal Code
2046
Country
Tunisia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mhamed Sami Mebazaa, professor
Phone
0021622252589
Email
msmebazaa@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Leg Elevation for Prevention of Post Spinal Hypotension in Cesarean Section
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