Complications; Cesarean Section, Hypotension, Obstetrical Complication of Anesthesia
Conditions
Keywords
norepinephrine, ephedrine
Brief summary
Incidence of hypotension is high in parturients after spinal anesthesia. Ephedrine could be used to treat hypotension but lead to lower fetal pH as well. This study is to compare the effects of norepinephrine and ephedrine on hypotension in parturients.
Detailed description
Spinal anesthesia is an accepted technique in elective cesarean sections. However, hypotension, resulted from sympathectomy is a common problem, especially in pregnant women. Prevention of this complication by sympathomimetic agents is of potential clinical significance. Ephedrine could be used to treat hypotension but lead to lower fetal pH, which may be related to worse fetal outcome.Norepinephrine could improve the hypotension to the same extent as phenylephrine. In this study, we tend to compare the effects of norepinephrine and ephedrine on hypotension in parturients and on fetal acid status.
Interventions
DRUGNorepinephrine
norepinephrine injection
DRUGEphedrine
Ephedrine injection
Sponsors
Air Force Military Medical University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients scheduled for elective cesarean section
Exclusion criteria
* Patients with severe pre-eclampsia * Patients with contraindications for spinal anesthesia * Patients with multiple pregnancy * Patients with gestation \<38w
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence of hypotension | from immediately after spinal anesthesia to 30min after spinal anesthesia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| incidence of dizzy | from immediately after spinal anesthesia to 30min after spinal anesthesia | — |
| incidence of chest congestion | from immediately after spinal anesthesia to 30min after spinal anesthesia | — |
| pH value of fetal arterial blood | just after clamp of the umbilical cord, usually 1min to 10min after start of the surgery | — |
| fetal arterial partial pressure of oxygen | just after clamp of the umbilical cord, usually 1min to 10min after start of the surgery | — |
| arterial base excess of fetal arterial blood | just after clamp of the umbilical cord, usually 1min to 10min after start of the surgery | — |
| incidence of nausea and vomiting | from immediately after spinal anesthesia to 30min after spinal anesthesia | — |
| lactate level of fetal arterial blood | just after clamp of the umbilical cord, usually 1min to 10min after start of the surgery | — |
| number of rescue vasoactive agent | from immediately after spinal anesthesia to 30min after spinal anesthesia | — |
| incidence of bradycardia | from immediately after spinal anesthesia to 30min after spinal anesthesia | — |
| incidence of dyspnea | from immediately after spinal anesthesia to 30min after spinal anesthesia | — |
| Apgar scores of the neonates | from clamp of umbilical cord to 1min after clamping | The Apgar score is a method to quickly summarize the health of newborn children.It is determined by evaluating the newborn baby on five simple criteria(Appearance, Pulse, Grimace, Activity, Respiration) on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. Scores 7 and above are generally normal; 4 to 6, fairly low; and 3 and below are generally regarded as critically low and cause for immediate resuscitative efforts |
| lowest neonatal cerebral oxygen saturation | from clamp of the umbilical cord to 10 min later, 10min in total | — |
Countries
China
Outcome results
None listed