Hypotension Clinical Trial
Official title:
Comparison of Norepinephrine and Ephedrine on Hypotension After Spinal Anesthesia in Parturients Undergoing Cesarean Section: a Randomized Double Blinded Controlled Study
Verified date | January 2019 |
Source | Fourth Military Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 66 |
Est. completion date | June 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
China | Xijing Hospital,Fourth Military Medical University | Xi'an | Shaanxi |
Lead Sponsor | Collaborator |
---|---|
Fourth Military Medical University |
China,
Carvalho B, Dyer RA. Norepinephrine for Spinal Hypotension during Cesarean Delivery: Another Paradigm Shift? Anesthesiology. 2015 Apr;122(4):728-30. doi: 10.1097/ALN.0000000000000602. — View Citation
Mitra JK, Roy J, Bhattacharyya P, Yunus M, Lyngdoh NM. Changing trends in the management of hypotension following spinal anesthesia in cesarean section. J Postgrad Med. 2013 Apr-Jun;59(2):121-6. doi: 10.4103/0022-3859.113840. Review. — View Citation
Moslemi F, Rasooli S. Comparison of Prophylactic Infusion of Phenylephrine with Ephedrine for Prevention of Hypotension in Elective Cesarean Section under Spinal Anesthesi: A Randomized Clinical Trial. Iran J Med Sci. 2015 Jan;40(1):19-26. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | incidence of hypotension | from immediately after spinal anesthesia to 30min after spinal anesthesia | ||
Secondary | pH value of fetal arterial blood | just after clamp of the umbilical cord, usually 1min to 10min after start of the surgery | ||
Secondary | incidence of nausea and vomiting | from immediately after spinal anesthesia to 30min after spinal anesthesia | ||
Secondary | incidence of dizzy | from immediately after spinal anesthesia to 30min after spinal anesthesia | ||
Secondary | incidence of chest congestion | from immediately after spinal anesthesia to 30min after spinal anesthesia | ||
Secondary | fetal arterial partial pressure of oxygen | just after clamp of the umbilical cord, usually 1min to 10min after start of the surgery | ||
Secondary | arterial base excess of fetal arterial blood | just after clamp of the umbilical cord, usually 1min to 10min after start of the surgery | ||
Secondary | lowest neonatal cerebral oxygen saturation | from clamp of the umbilical cord to 10 min later, 10min in total | ||
Secondary | lactate level of fetal arterial blood | just after clamp of the umbilical cord, usually 1min to 10min after start of the surgery | ||
Secondary | number of rescue vasoactive agent | from immediately after spinal anesthesia to 30min after spinal anesthesia | ||
Secondary | incidence of bradycardia | from immediately after spinal anesthesia to 30min after spinal anesthesia | ||
Secondary | incidence of dyspnea | from immediately after spinal anesthesia to 30min after spinal anesthesia | ||
Secondary | Apgar scores of the neonates | 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 | from clamp of umbilical cord to 1min after clamping | |
Secondary | Apgar scores of the neonates | 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 | from clamp of umbilical cord to 5min after clamping |
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