Norepinephrine Versus Ephedrin for Prevention of Post Spinal Anesthesia in Cesarean Section
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Mongi Slim Hospital
- Enrollment
- 200
- Primary Endpoint
- Incidence of post spinal hypotension
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 15 Years to 45 Years (Child, Adult)
- Sex
- Female
- Accepts 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
Exclusion Criteria
- •cesarean section under genearl anesthesia or epidural analgesia during labor
Arms & Interventions
norepinephrin group
The patients of this group will recieve 0.5 micro gr/kg of norepinephin intravenously, the infusion will start during the intrathecal injection and during 10 minutes
Intervention: Norepinephrine (Drug)
Ephedrin group
The patients of this group will recieve 0,3mg/kg of Ephedrin intravenously, the infusion will start during the intrathecal injection and during 10 minutes
Intervention: Ephedrine (Drug)
Outcomes
Primary Outcomes
Incidence of post spinal hypotension
Time Frame: during the first 20 minutes after spinal anesthesia
decrease of systolic arterial blood pressure \> 20% baseline
Secondary Outcomes
- Lowest systolic blood pressure(uring the first 20 minutes after spinal anesthesia)
- Incidence of bradycardia(during the first 20 minutes after spinal anesthesia)
- incidence of nausea and/or vomiting(during the first 20 minutes after spinal anesthesia)
- Apgar score(20min after spinal anesthesia)
- fetal ph(20min after spinal anesthesia)
- fetal blood lactates(20min after spinal anesthesia)
Investigators
Mhamed Sami Mebazaa
Head of the anesthesia intensive care department
Mongi Slim Hospital