Clinical trial NCT03507387: Preventive Intramuscular Phenylephrine in Elective Cesarean Section Under Spinal Anesthesia
Official title: Preventive Intramuscular Phenylephrine in Elective Cesarean Section Under Spinal Anesthesia: A Randomized Controlled Tiral
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elective Cesarean Section
Spinal Anesthesia
Keywords: Intramuscular
Phenylephrine
Lead sponsor: Xuzhou Medical University
Sponsor class: OTHER
First posted: 2018-04-25
Enrollment: 99
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Spinal anesthesia is the preferred anesthesia method in cesarean section to provide satisfactory analgesia and muscle relaxant with less impact on respiratory system. However, hypotension often occurred due to the block of sympathetic nerve, causing maternal decline of frontal lobe oxygenation, nausea vomit and the decrease of uteroplacental perfusion. Several measures are used to prevent or treat hypotension caused by spinal anesthesia: prehydration, limb compression, left lateral tilt of operation tables or usage of vasopressors. In the past decade, the most recommended vasopressor to prevent or treat hypotension in spinal anesthesia in cesarean section was phenylephrine, an α-adrenergic receptor, maintaining maternal blood pressure and fetal acid-base state. In clinical work, there are two ways to use phenylephrine : intravenous method with less onset time (several seconds and duration (several minutes) and intramuscular method with longer onset time (10-15 minutes) and duration (1 hour). Many trials demonstrated the protective effect of preventive intravenous phenylephrine on maternal hemodynamics and neonatal acid-base status. However, few trials reported the effect of preventive intramuscular phenylephrine on cesarean section under spinal anesthesia.

Detailed description: Hypotension often occurred in parturients undergoing cesarean section in spinal anesthesia. This study aims to determine whether preventive intramuscular phenylephrine can better the fetal acid-base state and maternal hemodynamics.

Eligibility criteria: Inclusion Criteria:

1. Age 18 years to 40 years.
2. Elective cesarean section
3. American Society of Anesthesiologists (ASA) grade from I to Ⅱ, height from 150 cm to 180 cm, BMI\<40kg/m2
4. Singleton pregnancy
5. Without pregnancy complications

Exclusion Criteria:

1. Multiple pregnancy
2. Preoperative bradycardia
3. Coagulation dysfunction
4. Parturients with hypertension, diabetes, eclampsia and other pregnancy complications.

Primary outcomes:
measure: Umbilical artery potential of hydrogen (pH)
timeFrame: after the baby is delivered
Secondary outcomes:
measure: Umbilical venous potential of hydrogen (pH)
timeFrame: after the baby is delivered
measure: Umbilical artery base excess
timeFrame: after the baby is delivered
measure: Umbilical venous base excess
timeFrame: after the baby is delivered
measure: Umbilical artery partial pressure of oxygen (PaO2)
timeFrame: after the baby is delivered
measure: Umbilical venous partial pressure of oxygen (PaO2)
timeFrame: after the baby is delivered
measure: Umbilical artery partial pressure of carbon dioxide (PaCO2)
timeFrame: after the baby is delivered
measure: Umbilical venous partial pressure of carbon dioxide (PaCO2)
timeFrame: after the baby is delivered
measure: Umbilical artery lactate
timeFrame: after the baby is delivered
measure: Umbilical venous lactate
timeFrame: after the baby is delivered
measure: Umbilical artery glucose
timeFrame: after the baby is delivered
measure: Umbilical venous glucose
timeFrame: after the baby is delivered
measure: Incidence of fetal acidosis
timeFrame: after the baby is delivered
measure: Incidence of hypotension
timeFrame: intraoperative
measure: Incidence of hypertension
timeFrame: intraoperative
measure: Incidence of bradycardia
timeFrame: intraoperative
measure: Incidence of nausea or vomit
timeFrame: intraoperative
Other outcomes:
Locations:
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
Study officials:
affiliation: The Affiliated Hospital of Xuzhou Medical University
name: Chao Xu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Foss VT, Christensen R, Rokamp KZ, Nissen P, Secher NH, Nielsen HB. Effect of phenylephrine vs. ephedrine on frontal lobe oxygenation during caesarean section with spinal anesthesia: an open label randomized controlled trial. Front Physiol. 2014 Mar 3;5:81. doi: 10.3389/fphys.2014.00081. eCollection 2014.
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citation: Thomas DG, Robson SC, Redfern N, Hughes D, Boys RJ. Randomized trial of bolus phenylephrine or ephedrine for maintenance of arterial pressure during spinal anaesthesia for Caesarean section. Br J Anaesth. 1996 Jan;76(1):61-5. doi: 10.1093/bja/76.1.61.
citation: Lin FQ, Qiu MT, Ding XX, Fu SK, Li Q. Ephedrine versus phenylephrine for the management of hypotension during spinal anesthesia for cesarean section: an updated meta-analysis. CNS Neurosci Ther. 2012 Jul;18(7):591-7. doi: 10.1111/j.1755-5949.2012.00345.x.
citation: Mohta M, Aggarwal M, Sethi AK, Harisinghani P, Guleria K. Randomized double-blind comparison of ephedrine and phenylephrine for management of post-spinal hypotension in potential fetal compromise. Int J Obstet Anesth. 2016 Aug;27:32-40. doi: 10.1016/j.ijoa.2016.02.004. Epub 2016 Feb 21.
citation: Saravanan S, Kocarev M, Wilson RC, Watkins E, Columb MO, Lyons G. Equivalent dose of ephedrine and phenylephrine in the prevention of post-spinal hypotension in Caesarean section. Br J Anaesth. 2006 Jan;96(1):95-9. doi: 10.1093/bja/aei265. Epub 2005 Nov 25.
citation: Magalhaes E, Goveia CS, de Araujo Ladeira LC, Nascimento BG, Kluthcouski SM. Ephedrine versus phenylephrine: prevention of hypotension during spinal block for cesarean section and effects on the fetus. Rev Bras Anestesiol. 2009 Jan-Feb;59(1):11-20. doi: 10.1590/s0034-70942009000100003. English, Portuguese.