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Clinical Trials/NCT03488277
NCT03488277
Unknown
Not Applicable

Evaluation of the Efficiency of Leg Elevation for Preventing Post Spinal Hypotension in Cesarean Section

Mongi Slim Hospital1 site in 1 country200 target enrollmentJanuary 10, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Effects of; Anesthesia, Spinal and Epidural, in Pregnancy
Sponsor
Mongi Slim Hospital
Enrollment
200
Locations
1
Primary Endpoint
Incidence of post spinal hypotension
Last Updated
8 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
January 10, 2018
End Date
December 31, 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Sequential
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mhamed Sami Mebazaa

Professor head of the anesthesia and intensive care department

Mongi Slim Hospital

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

Outcomes

Primary Outcomes

Incidence of post spinal hypotension

Time Frame: during the first 30minutes after the spinal anesthesia

change of systolic blood pressure from baseline\< 90 mmHg

Secondary Outcomes

  • Lowest systolic blood pressure(during the first 30 minutes following spinal anesthesia)
  • ephedrine consumption(during the first 30 minutes following the spinal anesthesia)
  • Fetal ph(30 minutes after spinal anesthesia)
  • Fetal blood lactates(30 minutes after spinal anesthesia)

Study Sites (1)

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