Cesarean, Maternal Hypotension Syndrome
Conditions
Brief summary
Spinal anesthesia is still the gold standard anesthetic method for elective and urgent cesarean section, the post spinal hypotension remains the most frequent complication of this procedure and is still responsible of considerable maternel and fetal morbidity. It is recommanded to prevent this post spinal hypotension with fluid coloading and prophylactic vasopressors administration. The aim of this study is to compare the efficency and the safety of norepinephrin and ephedrin prophylactic administration to reduce the incidence of post spinal hypotension in cesarean section.
Detailed description
Spinal anesthesia is still the gold standard anesthetic method for elective and urgent cesarean section, the post spinal hypotension remains the most frequent complication of this procedure and is still responsible of considerable maternel and fetal morbidity. It is recommanded to prevent this post spinal hypotension with fluid coloading and prophylactic vasopressors administration. The prophylactic use of norepinephrin and phenylephrin has been validated by several studies, but few data are published concerning the comparaison between norepinephrin and ephedrine as preventive vasopressors in cesarean section; these molecules act on alpha and beta adrenergic receptors and could provide better maternal hemodynamics in parturients undergoing cesarean section under spinal anesthesia. The aim of this study is to compare the efficency and the safety of norepinephrin and ephedrin prophylactic administration to reduce the incidence of post spinal hypotension in cesarean section.
Interventions
DRUGEphedrine
Comparaison of Norepinephrin and Ephedrin for prevention of the post spinal anesthesia in cesarean section
DRUGNorepinephrine
Comparaison of Norepinephrin and Ephedrin for prevention of the post spinal anesthesia in cesarean section
Sponsors
Mongi Slim Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Intervention model description
controlled, prospective, randomised trial comparing 2 interventions
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* full termed parturients scheduled for elective or semi urgent cesarean section under spinal anesthesia * AGE\>15 years * ASA II status * No history of hypertension, preeclampsia or cardiopathy * BMI\<40
Exclusion criteria
* cesarean section under genearl anesthesia or epidural analgesia during labor
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of post spinal hypotension | during the first 20 minutes after spinal anesthesia | decrease of systolic arterial blood pressure \> 20% baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of bradycardia | during the first 20 minutes after spinal anesthesia | heart rate\<50 beats/min |
| incidence of nausea and/or vomiting | during the first 20 minutes after spinal anesthesia | incidence of nausea and/or vomiting |
| Lowest systolic blood pressure | uring the first 20 minutes after spinal anesthesia | Lowest systolic blood pressure recorded after spinal anesthesia |
| fetal ph | 20min after spinal anesthesia | fetal ph |
| fetal blood lactates | 20min after spinal anesthesia | fetal blood lactates |
| Apgar score | 20min after spinal anesthesia | Apgar score at 1 min, 5 min, 10 min |
Contacts
Primary ContactAsma Ben Souissi, assistant professor
Backup ContactMhamed Sami Mebazaa, Professor
Outcome results
None listed