Effects of; Anesthesia, Spinal and Epidural, in Pregnancy
Conditions
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
Interventions
OTHERleg elevation
intra operative position that consists in leg elevation with a 30 cm height pillow under the patient's heels
Sponsors
Mongi Slim Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of post spinal hypotension | during the first 30minutes after the spinal anesthesia | change of systolic blood pressure from baseline\< 90 mmHg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lowest systolic blood pressure | during the first 30 minutes following spinal anesthesia | the lowest systolic blood pressure observed after spinal anesthesia |
| ephedrine consumption | during the first 30 minutes following the spinal anesthesia | total dose of Ephedrine received to treat post spinal hypotension |
| Fetal ph | 30 minutes after spinal anesthesia | fetal ph measured with blood gas analysis |
| Fetal blood lactates | 30 minutes after spinal anesthesia | fetal blood lactates (mmol/L) measured with blood gas analysis |
Countries
Tunisia
Contacts
Primary ContactMhamed Sami Mebazaa, professor
Backup ContactAsma Ben Souissi
Outcome results
None listed