Preventive Intramuscular Phenylephrine in Elective Cesarean Section Under Spinal Anesthesia

Spinal Anesthesia Clinical Trial

Official title:

Preventive Intramuscular Phenylephrine in Elective Cesarean Section Under Spinal Anesthesia: A Randomized Controlled Tiral

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03507387
• Other study ID #: XYFY2018-KL010-01
• Status: Completed
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: August 31, 2018

Study information

• Verified date: July 2019
• Source: Xuzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

1. Age 18 years to 40 years.

2. Elective cesarean section

3. American Society of Anesthesiologists (ASA) grade from I to ?, 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.

Related Conditions & MeSH terms

• Elective Cesarean Section
• Spinal Anesthesia

Intervention

Drug:
• Phenylephrine
5 mg (1ml) phenylephrine intramuscular injection will be given into the gluteus maximus muscle before anesthesia.100ug (1ml) phenylephrine intravenous injection will be given after the subarachnoid injection is completed .
• Normal saline
1ml 0.9% normal saline intramuscular injection will be given into the gluteus maximus muscle before anesthesia and after the subarachnoid injection is completed.
• Bupivacaine
All patients will receive spinal anesthesia with bupivacaine.

Locations

Country	Name	City	State
China	The Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Xuzhou Medical University

Country where clinical trial is conducted

China, 

References & Publications (8)

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;5:8 — View 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. — View Citation

Macarthur A, Riley ET. Obstetric anesthesia controversies: vasopressor choice for postspinal hypotension during cesarean delivery. Int Anesthesiol Clin. 2007 Winter;45(1):115-32. Review. — View Citation

Magalhães E, Govêia CS, de Araújo 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. Englis — View 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.ijo — View Citation

Mon W, Stewart A, Fernando R, Ashpole K, El-Wahab N, MacDonald S, Tamilselvan P, Columb M, Liu YM. Cardiac output changes with phenylephrine and ephedrine infusions during spinal anesthesia for cesarean section: A randomized, double-blind trial. J Clin An — View 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. Epub 2005 Nov 25. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Umbilical artery potential of hydrogen (pH)	detected by a blood gase analyzer	after the baby is delivered
Secondary	Umbilical venous potential of hydrogen (pH)	detected by a blood gase analyzer	after the baby is delivered
Secondary	Umbilical artery base excess	detected by a blood gase analyzer	after the baby is delivered
Secondary	Umbilical venous base excess	detected by a blood gase analyzer	after the baby is delivered
Secondary	Umbilical artery partial pressure of oxygen (PaO2)	detected by a blood gase analyzer	after the baby is delivered
Secondary	Umbilical venous partial pressure of oxygen (PaO2)	detected by a blood gase analyzer	after the baby is delivered
Secondary	Umbilical artery partial pressure of carbon dioxide (PaCO2)	detected by a blood gase analyzer	after the baby is delivered
Secondary	Umbilical venous partial pressure of carbon dioxide (PaCO2)	detected by a blood gase analyzer	after the baby is delivered
Secondary	Umbilical artery lactate	detected by a blood gase analyzer	after the baby is delivered
Secondary	Umbilical venous lactate	detected by a blood gase analyzer	after the baby is delivered
Secondary	Umbilical artery glucose	detected by a blood gase analyzer	after the baby is delivered
Secondary	Umbilical venous glucose	detected by a blood gase analyzer	after the baby is delivered
Secondary	Incidence of fetal acidosis	Umbilical artery pH value<7.20	after the baby is delivered
Secondary	Incidence of hypotension	decrease of systolic blood pressure>20% baseline values	intraoperative
Secondary	Incidence of hypertension	increase of systolic blood pressure>20% baseline values	intraoperative
Secondary	Incidence of bradycardia	heart rate <50 bpm	intraoperative
Secondary	Incidence of nausea or vomit	observed by the anesthesiologist	intraoperative