AzTrials
AzTrials

Hypotension Symptomaticannie-zoeNCT04404946

Colloid Co-hydration and Vasoconstrictor Infusion for Prevention of Hypotension During Cesarean Section

A study testing phenylephrine infusion and norepinephrine infusion in people with Hypotension Symptomatic and Vasoconstriction, run by Aretaieion University Hospital at 1 site in Greece.

Completed

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

Official record
Search all trials

Trial summary

This will be a double-blind randomized study, aiming at investigating a fixed rate phenylephrine infusion versus a fixed rate norepinephrine infusion versus placebo in combination with co-hydration with colloids for the prevention of maternal hypotension in elective cesarean section Read more about this study

Who is it for?
Ages 18 to 48 years, women only
What is being tested?
phenylephrine infusion and norepinephrine infusion
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteGreece
Study dates
23 May 2020to 31 May 2021
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 48 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • adult parturients, American Society of Anesthesiologists (ASA) I-II,
  • singleton gestation>37 weeks
  • elective cesarean section

Who cannot join

  • Body Mass Index (BMI) >40 kg/m2
  • Body weight <50 kg
  • Body weight>100 kg
  • height<150 cm
  • height>180 cm
  • multiple gestation
Show all 17Show fewer
  • fetal abnormality
  • fetal distress
  • active labor
  • cardiac disease
  • pregnancy-induced hypertension
  • thrombocytopenia
  • coagulation abnormalities
  • use of antihypertensive medication during pregnancy
  • communication or language barriers
  • lack of informed consent
  • contraindication for regional anesthesia

Trial locations and contacts

1 site in 1 country.

Greece1 site

  • Aretaieion University Hospital

    Athens, 115 28

Other trials in Greece

About this study

Official title: Colloid Co-hydration and Vasoconstrictor Infusion for Prevention of Postspinal Hypotension During Elective Cesarean Section. A Comparative Study

This will be a double-blind randomized study, aiming at investigating a fixed rate phenylephrine infusion versus a fixed rate norepinephrine infusion versus placebo in combination with co-hydration with colloids for the prevention of maternal hypotension in elective cesarean section

Read the detailed description

Neuraxial techniques are the anesthetic techniques of choice in contemporary obstetric anesthesia practice, with a definitive superiority as compared to general anesthesia, since, by their use, serious complications involving the airway can be avoided.Spinal anesthesia has become the favorable technique for both elective and emergency cesarean section due to a quick and predictable onset of action, however, it can be frequently complicated by hypotension, with incidence exceeding 80% occasionally.

The aim of the current randomized controlled double-blinded trial was to compare the effect of a fixed-rate norepinephrine infusion versus a fixed-rate phenylephrine infusion versus placebo in parturients subjected to elective cesarean section under combined spinal-epidural anesthesia. All parturients will also receive colloid co-hydration.

Being tested
phenylephrine infusion, norepinephrine infusion, placebo infusion

What participants receive

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

  • phenylephrine infusionOther

    Also called medication used for blood pressure maintenance

    in parturients allocated to the phenylephrine group, a phenylephrine infusion will be started as soon as spinal anesthesia is initiated

  • norepinephrine infusionOther

    Also called medication used for blood pressure maintenance

    in parturients allocated to the norepinephrine group, a norepinephrine infusion will be started as soon as spinal anesthesia is initiated

  • placebo infusionOther

    Also called medication used for blood pressure maintenance

    in parturients allocated to the placebo group, a normal saline infusion will be started as soon as spinal anesthesia is initiated

Study groups in NCT04404946
Study groupRoleWhat they receive
phenylephrine infusionActive comparatorfixed-rate phenylephrine infusion
Receives: Other: phenylephrine infusion
norepinephrine infusionActive comparatorfixed-rate norepinephrine infusion
Receives: Other: norepinephrine infusion
placebo infusionPlacebo comparatornormal saline infusion
Receives: Other: placebo infusion

What is being measured

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

  1. incidence of bradycardia

    any incidence of maternal bradycardia (heart rate<60/min) will be recorded

    Measured: intraoperative

  2. incidence of hypotension

    any occurence of hypotension (systolic blood pressure<80% of baseline) throughout the operation will be recorded

    Measured: intraoperative

Secondary outcomes (14)

  1. need for vasoconstrictor

    any need for vasoconstrictor during the operation will be recorded

    Measured: intraoperative

  2. type of vasoconstrictor administered

    phenylephrine versus ephedrine

    Measured: intraoperative

  3. number of bolus doses of vasoconstrictor administered

    number of interventions to maintain systolic blood pressure within the set limits will be recorded

    Measured: intraoperative

  4. total dose of vasoconstrictor administered

    total dose in mg for ephedrine or μg for phenylephrine administered

    Measured: intraoperative

  5. incidence of hypertension

    any incidence of systolic blood pressure>120% of baseline will be recorded

    Measured: intraoperative

  6. need for atropine

    any need for atropine during the operation because of bradycardia will be recorded

    Measured: intraoperative

  7. modification or cessation of the infusion

    any requirement for modification or cessation of the infusion due to reactive hypertension or bradycardia will be recorded

    Measured: intraoperative

  8. incidence of nausea/vomiting

    any occurence of nausea and/or vomiting during the operation will be recorded

    Measured: intraoperative

  9. Neonatal Apgar score at 1 minutes

    Neonatal Apgar score will be recorded at 1 minutes after delivery. The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. Scores 7 and above are generally normal; 4 to 6, fairly low; and 3 and below are generally regarded as critically low and cause for immediate resuscitative efforts.

    Measured: 1 minute post delivery

  10. Neonatal Apgar score at 5 minutes

    Neonatal Apgar score will be recorded at 5 minutes after delivery. The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. Scores 7 and above are generally normal; 4 to 6, fairly low; and 3 and below are generally regarded as critically low and cause for immediate resuscitative efforts.

    Measured: 5 minutes post delivery

  11. neonatal blood gases

    fetal cord blood analysis will be performed immediately post-delivery

    Measured: 1 minute post delivery

  12. glucose in neonatal blood

    glucose will be measured in the cord blood gas sample taken immediately post-delivery

    Measured: 1 minute post delivery

  13. adrenaline in neonatal blood

    an amount of the umbilical artery cord blood sampled from every neonate will be sent for lab measurements

    Measured: 5 minutes post delivery

  14. noradrenaline in neonatal blood

    an amount of the umbilical artery cord blood sampled from every neonate will be sent for lab measurements

    Measured: 5 minutes post delivery

Timeline

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

  1. First posted28 May 2020
  2. Study start23 May 2020
  3. Primary completion31 May 2021
  4. Study completion31 May 2021

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04404946
Sponsor's protocol ID
196/25-02-2020
Acronym
annie-zoe
Status last verified
Jun 2021
First submitted
22 May 2020
Last updated
15 Jun 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Langesaeter E, Dyer RA. Maternal haemodynamic changes during spinal anaesthesia for caesarean section. Curr Opin Anaesthesiol. 2011 Jun;24(3):242-8. doi: 10.1097/ACO.0b013e32834588c5.

    PubMed 21415724

  • Ngan Kee WD. Prevention of maternal hypotension after regional anaesthesia for caesarean section. Curr Opin Anaesthesiol. 2010 Jun;23(3):304-9. doi: 10.1097/ACO.0b013e328337ffc6.

    PubMed 20173633

  • Kinsella SM, Carvalho B, Dyer RA, Fernando R, McDonnell N, Mercier FJ, Palanisamy A, Sia ATH, Van de Velde M, Vercueil A; Consensus Statement Collaborators. International consensus statement on the management of hypotension with vasopressors during caesarean section under spinal anaesthesia. Anaesthesia. 2018 Jan;73(1):71-92. doi: 10.1111/anae.14080. Epub 2017 Nov 1. No abstract available.

    PubMed 29090733

  • Mets B. Should Norepinephrine, Rather than Phenylephrine, Be Considered the Primary Vasopressor in Anesthetic Practice? Anesth Analg. 2016 May;122(5):1707-14. doi: 10.1213/ANE.0000000000001239. No abstract available.

    PubMed 27101504

  • Carvalho B, Dyer RA. Norepinephrine for Spinal Hypotension during Cesarean Delivery: Another Paradigm Shift? Anesthesiology. 2015 Apr;122(4):728-30. doi: 10.1097/ALN.0000000000000602. No abstract available.

    PubMed 25654435

  • Sen I, Hirachan R, Bhardwaj N, Jain K, Suri V, Kumar P. Colloid cohydration and variable rate phenylephrine infusion effectively prevents postspinal hypotension in elective Cesarean deliveries. J Anaesthesiol Clin Pharmacol. 2013 Jul;29(3):348-55. doi: 10.4103/0970-9185.117106.

    PubMed 24106360

  • Gunusen I, Karaman S, Ertugrul V, Firat V. Effects of fluid preload (crystalloid or colloid) compared with crystalloid co-load plus ephedrine infusion on hypotension and neonatal outcome during spinal anaesthesia for caesarean delivery. Anaesth Intensive Care. 2010 Jul;38(4):647-53. doi: 10.1177/0310057X1003800337.

    PubMed 20715726

  • Kulkarni KR, Naik AG, Deshpande SG. Evaluation of antihypotensive techniques for cesarean section under spinal anesthesia: Rapid crystalloid hydration versus intravenous ephedrine. Anesth Essays Res. 2016 Sep-Dec;10(3):637-642. doi: 10.4103/0259-1162.191118.

    PubMed 27746565

Questions about this trial

What is this clinical trial studying?

A study testing phenylephrine infusion and norepinephrine infusion in people with Hypotension Symptomatic and Vasoconstriction, run by Aretaieion University Hospital at 1 site in Greece.

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 3 inclusion and 17 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 15 Jun 2021. 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 Greece. 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?

incidence of bradycardia (time frame: intraoperative). The study lists 2 primary outcomes in all. 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 NCT04404946, 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 15 Jun 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in