NCT03507387

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 25, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
Last Updated

July 5, 2019

Status Verified

July 1, 2019

Enrollment Period

5 months

First QC Date

April 7, 2018

Last Update Submit

July 2, 2019

Conditions

Elective Cesarean SectionSpinal Anesthesia

Keywords

IntramuscularPhenylephrine

Outcome Measures

Primary Outcomes (1)

  • Umbilical artery potential of hydrogen (pH)

    detected by a blood gase analyzer

    after the baby is delivered

Secondary Outcomes (16)

  • Umbilical venous potential of hydrogen (pH)

    after the baby is delivered

  • Umbilical artery base excess

    after the baby is delivered

  • Umbilical venous base excess

    after the baby is delivered

  • Umbilical artery partial pressure of oxygen (PaO2)

    after the baby is delivered

  • Umbilical venous partial pressure of oxygen (PaO2)

    after the baby is delivered

  • +11 more secondary outcomes

Study Arms (3)

Intramuscular phenylephrine group

EXPERIMENTAL

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: PhenylephrineDrug: Normal salineDrug: Bupivacaine

Intravenous phenylephrine group

ACTIVE COMPARATOR

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: PhenylephrineDrug: Normal salineDrug: Bupivacaine

Placebo group

PLACEBO COMPARATOR

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: PhenylephrineDrug: Normal salineDrug: Bupivacaine

Interventions

PhenylephrineDRUG

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 .

Also known as: Metasympatol
Intramuscular phenylephrine groupIntravenous phenylephrine groupPlacebo group
Normal salineDRUG

1ml 0.9% normal saline intramuscular injection will be given into the gluteus maximus muscle before anesthesia and after the subarachnoid injection is completed.

Also known as: Physiological saline
Intramuscular phenylephrine groupIntravenous phenylephrine groupPlacebo group
BupivacaineDRUG

All patients will receive spinal anesthesia with bupivacaine.

Also known as: Marcaine
Intramuscular phenylephrine groupIntravenous phenylephrine groupPlacebo group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221000, China

Location

Related 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;5:81. doi: 10.3389/fphys.2014.00081. eCollection 2014.

    PMID: 24624090RESULT

  • Macarthur A, Riley ET. Obstetric anesthesia controversies: vasopressor choice for postspinal hypotension during cesarean delivery. Int Anesthesiol Clin. 2007 Winter;45(1):115-32. doi: 10.1097/AIA.0b013e31802b8d53. No abstract available.

    PMID: 17215703RESULT

  • 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.

    PMID: 28235526RESULT

  • 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.

    PMID: 8672382RESULT

  • 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.

    PMID: 22759268RESULT

  • 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.

    PMID: 27020488RESULT

  • 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.

    PMID: 16311286RESULT

  • 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.

    PMID: 19374211RESULT

MeSH Terms

Interventions

PhenylephrineSaline SolutionBupivacaine

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsAnilidesAmidesAniline Compounds

Study Officials

  • Chao Xu, M.D.

    The Affiliated Hospital of Xuzhou Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 7, 2018

First Posted

April 25, 2018

Study Start

April 1, 2018

Primary Completion

August 31, 2018

Study Completion

August 31, 2018

Last Updated

July 5, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)