Leg Elevation for Prevention of Post Spinal Hypotension in Cesarean Section
NCT ID: NCT03488277
Last Updated: 2018-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2018-01-10
2018-12-31
Brief Summary
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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.
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
PREVENTION
NONE
Study Groups
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LE: leg elevation group
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
leg elevation
intra operative position that consists in leg elevation with a 30 cm height pillow under the patient's heels
CG: Control group
The patients of this group will be positiooned in supine with 15° left tlit after spinal anesthesia. no leg elevation
No interventions assigned to this group
Interventions
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leg elevation
intra operative position that consists in leg elevation with a 30 cm height pillow under the patient's heels
Eligibility Criteria
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Inclusion Criteria
* age\> 18 Y
* scheduled of elective or urgent cesarean section under spinal anesthesia
Exclusion Criteria
18 Years
FEMALE
Yes
Sponsors
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Mongi Slim Hospital
OTHER
Responsible Party
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Mhamed Sami Mebazaa
Professor head of the anesthesia and intensive care department
Principal Investigators
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Mhamed Sami Mebazaa, Professor
Role: PRINCIPAL_INVESTIGATOR
Mongi Slim Hospital
Locations
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Mongi Slim Hospital
La Marsa, Tunis Governorate, Tunisia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Mater1
Identifier Type: -
Identifier Source: org_study_id
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