Comparison of Norepinephrine and Ephedrine on Hypotension After Spinal Anesthesia in Parturients

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02542748
• Other study ID #: XJH-A-2015-5-5-01
• Status: Completed
• Phase: N/A
• Start date: October 5, 2015
• Est. completion date: June 2016

Study information

• Verified date: January 2019
• Source: Fourth Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Complications; Cesarean Section
• Hypotension
• Obstetric Labor Complications
• Obstetrical Complication of Anesthesia

Intervention

Drug:
• Norepinephrine
norepinephrine injection
• Ephedrine
Ephedrine injection

Locations

Country	Name	City	State
China	Xijing Hospital,Fourth Military Medical University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Fourth Military Medical University

Country where clinical trial is conducted

China, 

References & Publications (3)

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

Outcome

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