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

Comparison of Norepinephrine and Ephedrine on Hypotension After Spinal Anesthesia in Parturients Undergoing Cesarean Section: a Randomized Double Blinded Controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Hypotension; Complications; Cesarean Section; Obstetrical Complication of Anesthesia
• Intervention / Treatment: Drug: Norepinephrine; Drug: Ephedrine

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.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Xijing Hospital,Fourth Military Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: norepinephrine; norepinephrine is injected after spinal anesthesia	Drug: Norepinephrine; norepinephrine injection; Other Names: vasoactive agents
Other: ephedrine; ephedrine is injected after spinal anesthesia	Drug: Ephedrine; Ephedrine injection; Other Names: vasoactive agents

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
incidence of hypotension	from immediately after spinal anesthesia to 30min after spinal anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pH value 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
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
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
lowest neonatal cerebral oxygen saturation		from clamp of the umbilical cord to 10 min later, 10min in total
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	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
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

Collaborators and Investigators

• Sponsor: Air Force Military Medical University, China
• Investigators: Study Chair: Hailong DONG, Prof., Xijing Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: September 3, 2015
• First Submitted That Met QC Criteria: September 3, 2015
• First Posted (Estimate): September 7, 2015

Study Record Updates

• Last Update Posted (Actual): January 15, 2019
• Last Update Submitted That Met QC Criteria: January 12, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: ephedrine; norepinephrine
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Central Nervous System Stimulants; Sympathomimetics; Vasoconstrictor Agents; Norepinephrine; Ephedrine
• Other Study ID Numbers: XJH-A-2015-5-5-01