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Elective Cesarean SectionNCT03507387

Preventive Intramuscular Phenylephrine in Elective Cesarean Section Under Spinal Anesthesia

A study testing Phenylephrine, Normal saline and Bupivacaine in people with Elective Cesarean Section and Spinal Anesthesia, run by Xuzhou Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 40 years, women only
Conditions the study is for
Elective Cesarean Section, Spinal Anesthesia
What is being tested?
Phenylephrine, Normal saline and Bupivacaine
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
99 participants
Where
1 siteChina
Study dates
1 Apr 2018to 31 Aug 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221000

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Phenylephrine, Normal saline, Bupivacaine
Keywords
Intramuscular, Phenylephrine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PhenylephrineDrug

    Also called Metasympatol

    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 salineDrug

    Also called Physiological 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.

  • BupivacaineDrug

    Also called Marcaine

    All patients will receive spinal anesthesia with bupivacaine.

Study groups in NCT03507387
Study groupRoleWhat they receive
Intramuscular phenylephrine groupExperimentalPatients 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.
Receives: Drug: Phenylephrine; Drug: Normal saline; Drug: Bupivacaine
Intravenous phenylephrine groupActive comparatorPatients 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.
Receives: Drug: Phenylephrine; Drug: Normal saline; Drug: Bupivacaine
Placebo groupPlacebo comparatorPatients 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.
Receives: Drug: Phenylephrine; Drug: Normal saline; Drug: Bupivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Umbilical artery potential of hydrogen (pH)

    detected by a blood gase analyzer

    Measured: after the baby is delivered

Secondary outcomes (16)

  1. Umbilical venous potential of hydrogen (pH)

    detected by a blood gase analyzer

    Measured: after the baby is delivered

  2. Umbilical artery base excess

    detected by a blood gase analyzer

    Measured: after the baby is delivered

  3. Umbilical venous base excess

    detected by a blood gase analyzer

    Measured: after the baby is delivered

  4. Umbilical artery partial pressure of oxygen (PaO2)

    detected by a blood gase analyzer

    Measured: after the baby is delivered

  5. Umbilical venous partial pressure of oxygen (PaO2)

    detected by a blood gase analyzer

    Measured: after the baby is delivered

  6. Umbilical artery partial pressure of carbon dioxide (PaCO2)

    detected by a blood gase analyzer

    Measured: after the baby is delivered

  7. Umbilical venous partial pressure of carbon dioxide (PaCO2)

    detected by a blood gase analyzer

    Measured: after the baby is delivered

  8. Umbilical artery lactate

    detected by a blood gase analyzer

    Measured: after the baby is delivered

  9. Umbilical venous lactate

    detected by a blood gase analyzer

    Measured: after the baby is delivered

  10. Umbilical artery glucose

    detected by a blood gase analyzer

    Measured: after the baby is delivered

  11. Umbilical venous glucose

    detected by a blood gase analyzer

    Measured: after the baby is delivered

  12. Incidence of fetal acidosis

    Umbilical artery pH value<7.20

    Measured: after the baby is delivered

  13. Incidence of hypotension

    decrease of systolic blood pressure>20% baseline values

    Measured: intraoperative

  14. Incidence of hypertension

    increase of systolic blood pressure>20% baseline values

    Measured: intraoperative

  15. Incidence of bradycardia

    heart rate <50 bpm

    Measured: intraoperative

  16. Incidence of nausea or vomit

    observed by the anesthesiologist

    Measured: intraoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2018
  2. Study start1 Apr 2018
  3. Primary completion31 Aug 2018
  4. Study completion31 Aug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
99 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03507387
Sponsor's protocol ID
XYFY2018-KL010-01
Status last verified
Jul 2019
First submitted
7 Apr 2018
Last updated
5 Jul 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 24624090

  • 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.

    PubMed 17215703

  • 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.

    PubMed 28235526

  • 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.

    PubMed 8672382

  • 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.

    PubMed 22759268

  • 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.

    PubMed 27020488

  • 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.

    PubMed 16311286

  • 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.

    PubMed 19374211

Questions about this trial

What is this clinical trial studying?

A study testing Phenylephrine, Normal saline and Bupivacaine in people with Elective Cesarean Section and Spinal Anesthesia, run by Xuzhou Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Umbilical artery potential of hydrogen (pH) (time frame: after the baby is delivered). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03507387, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.

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