Clinical trial NCT02542748: Comparison of Norepinephrine and Ephedrine on Hypotension After Spinal Anesthesia in Parturients
Official title: Comparison of Norepinephrine and Ephedrine on Hypotension After Spinal Anesthesia in Parturients Undergoing Cesarean Section: a Randomized Double Blinded Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypotension
Obstetrical Complication of Anesthesia
Complications; Cesarean Section
Keywords: norepinephrine
ephedrine
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2015-09-07
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: incidence of hypotension
timeFrame: from immediately after spinal anesthesia to 30min after spinal anesthesia
Secondary outcomes:
measure: pH value of fetal arterial blood
timeFrame: just after clamp of the umbilical cord, usually 1min to 10min after start of the surgery
measure: incidence of nausea and vomiting
timeFrame: from immediately after spinal anesthesia to 30min after spinal anesthesia
measure: incidence of dizzy
timeFrame: from immediately after spinal anesthesia to 30min after spinal anesthesia
measure: incidence of chest congestion
timeFrame: from immediately after spinal anesthesia to 30min after spinal anesthesia
measure: fetal arterial partial pressure of oxygen
timeFrame: just after clamp of the umbilical cord, usually 1min to 10min after start of the surgery
measure: arterial base excess of fetal arterial blood
timeFrame: just after clamp of the umbilical cord, usually 1min to 10min after start of the surgery
measure: lowest neonatal cerebral oxygen saturation
timeFrame: from clamp of the umbilical cord to 10 min later, 10min in total
measure: lactate level of fetal arterial blood
timeFrame: just after clamp of the umbilical cord, usually 1min to 10min after start of the surgery
measure: number of rescue vasoactive agent
timeFrame: from immediately after spinal anesthesia to 30min after spinal anesthesia
measure: incidence of bradycardia
timeFrame: from immediately after spinal anesthesia to 30min after spinal anesthesia
measure: incidence of dyspnea
timeFrame: from immediately after spinal anesthesia to 30min after spinal anesthesia
measure: Apgar scores of the neonates
timeFrame: from clamp of umbilical cord to 1min after clamping
measure: Apgar scores of the neonates
timeFrame: from clamp of umbilical cord to 5min after clamping
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital,Fourth Military Medical University
state: Shaanxi
Study officials:
affiliation: Xijing Hospital
name: Hailong DONG, Prof.
role: STUDY_CHAIR
References:
citation: 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. No abstract available.
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.
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.
citation: Fan QQ, Wang YH, Fu JW, Dong HL, Yang MP, Liu DD, Jiang XF, Wu ZX, Xiong LZ, Lu ZH. Comparison of two vasopressor protocols for preventing hypotension post-spinal anesthesia during cesarean section: a randomized controlled trial. Chin Med J (Engl). 2021 Mar 4;134(7):792-799. doi: 10.1097/CM9.0000000000001404.