Preventive Intramuscular Phenylephrine in Elective Cesarean Section Under Spinal Anesthesia

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ClinicalTrials.gov Identifier: NCT03507387

Recruitment Status : Completed

First Posted : April 25, 2018

Last Update Posted : July 5, 2019

Sponsor:

Information provided by (Responsible Party):

Chao Xu, Xuzhou Medical University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Elective Cesarean Section Spinal Anesthesia	Drug: Phenylephrine Drug: Normal saline Drug: Bupivacaine	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	99 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	Preventive Intramuscular Phenylephrine in Elective Cesarean Section Under Spinal Anesthesia: A Randomized Controlled Tiral
Actual Study Start Date :	April 1, 2018
Actual Primary Completion Date :	August 31, 2018
Actual Study Completion Date :	August 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Drug Information available for: Phenylephrine Phenylephrine hydrochloride Oxymetazoline Oxymetazoline hydrochloride Bupivacaine

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intramuscular phenylephrine group Patients in intramuscular phenylephrine group will receive spinal anesthesia with bupivacaine. 5 mg (1ml) phenylephrine intramuscular injection will be given into the gluteus maximus muscle before anesthesia.1ml of 0.9% normal saline intravenous injection will be given after the subarachnoid injection is completed.	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 . Other Name: Metasympatol Drug: 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. Other Name: Physiological saline Drug: Bupivacaine All patients will receive spinal anesthesia with bupivacaine. Other Name: Marcaine
Active Comparator: Intravenous phenylephrine group Patients in intravenous phenylephrine group will receive spinal anesthesia with bupivacaine. 1ml of 0.9% normal saline 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.	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 . Other Name: Metasympatol Drug: 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. Other Name: Physiological saline Drug: Bupivacaine All patients will receive spinal anesthesia with bupivacaine. Other Name: Marcaine
Placebo Comparator: Placebo group Patients in intravenous phenylephrine group will receive spinal anesthesia with bupivacaine. 1ml of 0.9% normal saline intramuscular injection will be given into the gluteus maximus muscle before anesthesia. 1ml of 0.9% normal saline intravenous injection will be given after the subarachnoid injection is completed.	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 . Other Name: Metasympatol Drug: 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. Other Name: Physiological saline Drug: Bupivacaine All patients will receive spinal anesthesia with bupivacaine. Other Name: Marcaine

Outcome Measures

Primary Outcome Measures :

Umbilical artery potential of hydrogen (pH) [ Time Frame: after the baby is delivered ]
detected by a blood gase analyzer

Secondary Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 40 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03507387

Locations

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China, Jiangsu
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China, 221000

Sponsors and Collaborators

Xuzhou Medical University

Investigators

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Principal Investigator:	Chao Xu, M.D.	The Affiliated Hospital of Xuzhou Medical University

More Information

Publications of Results:

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.

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.

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 Anesth. 2017 Feb;37:43-48. doi: 10.1016/j.jclinane.2016.11.001. Epub 2016 Dec 26.

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.

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.

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.

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.

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. English, Portuguese.

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Responsible Party:	Chao Xu, Principal Investigator, Xuzhou Medical University
ClinicalTrials.gov Identifier:	NCT03507387
Other Study ID Numbers:	XYFY2018-KL010-01
First Posted:	April 25, 2018 Key Record Dates
Last Update Posted:	July 5, 2019
Last Verified:	July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Chao Xu, Xuzhou Medical University:


Intramuscular Phenylephrine

Additional relevant MeSH terms:

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Phenylephrine Oxymetazoline Bupivacaine Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Cardiotonic Agents Mydriatics Autonomic Agents	Sympathomimetics Vasoconstrictor Agents Nasal Decongestants Respiratory System Agents Adrenergic alpha-1 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Protective Agents

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