Cesarean Section ComplicationsPhase 4PHENADNCT03849508
Phenylephrine Versus Norepinephrine for Maintenance of Hemodynamic During Cesarean Section Under Spinal Anesthesia
A Phase 4 study testing Norepinephrine and Phenylephrine in people with Cesarean Section Complications and Spinal Anesthesia, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
Trial summary
Comparison between prophylactic continuous variable infusion of phenylephrine (starting dose 0,5mcg/kg/min) and norepinephrine tartrate (starting dose 0,1mcg/kg/min) to prevent hypotension and maintain cardiac output under spinal anesthesia during cesarean delivery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cesarean Section Complications, Spinal Anesthesia
- What is being tested?
- Norepinephrine and Phenylephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteFrance
- Study dates
- 27 Feb 2019to 2 Dec 2020
- Phase
- Phase 4
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnancy higher than 36 weeks of amenorrhea
- Scheduled or semi-urgent (interval between decision and delivery by cesarean section higher than 12hours) cesarean section under spinal anesthesia
Who cannot join
- Extreme height (less than 140cm; higher than 180cm)
- Weight less than 50kg
- Weight higher than 120kg
- Cardiovascular disease with use of cardiac medication (including antihypertensive drug)
- Active neurological disease
- Anti-hypertension treatment.
Show all 16Show fewer
- High blood pressure or severe pre-eclampsia
- American Society of Anesthesiologists physical status class higher than 3
- Placenta accrete/percreta
- Cesarean section scheduled under general anesthesia
- Contraindications to spinal anesthesia
- Minor (age less than 18 years old)
- Guardianship/ curatorship
- Anemia less than or equal to 8 g/dl
- Allergy to any study medication
- Simultaneous participation in another study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind, Controlled Clinical Trial for Comparison of Continuous Phenylephrine Versus Norepinephrine Infusion for Maintenance of Hemodynamic Stability During Cesarean Section Under Spinal Anesthesia
Comparison between prophylactic continuous variable infusion of phenylephrine (starting dose 0,5mcg/kg/min) and norepinephrine tartrate (starting dose 0,1mcg/kg/min) to prevent hypotension and maintain cardiac output under spinal anesthesia during cesarean delivery.
Read the detailed description
Maternal hypotension is a frequent complication after spinal anesthesia for cesarean delivery. Many vasopressors have been studied and used, but the perfect vasopressor is yet to be found. Phenylephrine is the most common used in obstetric anesthesia but its cardiac depressant activity, being an only alpha-adrenergic agonistic, is linked to frequent side effects such as bradycardia and decreased cardiac output.
Norepinephrine is a vasopressor characterized by both alpha and minor beta-adrenergic agonistic activity, it has then a minimal cardiac depressant activity. Hence it would provide a better stability of hemodynamic and cardiac output, and appears as a better alternative to phenylephrine.
In this study, the investigators will compare prophylactic continuous variable infusion of both vasopressors. Phenylephrine started at the dose of 0,5mcg/kg/min and Norepinephrine tartrate started at the dose of 0,1mcg/kg/min. The doses will be adjusted according to maternal systolic blood pressure in order to prevent hypotension (defined by a systolic blood pressure under 80% of baseline).
- Conditions
- Cesarean Section Complications, Spinal Anesthesia
- Being tested
- Norepinephrine, Phenylephrine
- Keywords
- cesarean section complications, spinal anesthesia, norepinephrine, maternal hemodynamic and cardiac output
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NorepinephrineDrug
Drug: Norepinephrine Norepinephrine tartrate variable infusion with a starting rate of 0,1μg/kg/min (equivalent to norepinephrine base of 0.05 μg /Kg/min).
Other name: Noradrenaline
Drug: Hyperbaric Bupivacaine will be injected in the subarachnoid space with a dose of 8 to 12 mg adjusted according to height
Drug: Sufentanil will be injected in the subarachnoid space with a dose of 2,5μg
Drug: Morphine will be injected in the subarachnoid space with a dose of 100 μg
PhenylephrineDrug
Drug: Phenylephrine variable infusion with a starting rate of 0,5μg/kg/min
Drug: Hyperbaric Bupivacaine will be injected in the subarachnoid space with a dose of 8 to 12 mg adjusted according to height
Drug: Sufentanil will be injected in the subarachnoid space with a dose of 2,5μg
Drug: Morphine will be injected in the subarachnoid space with a dose of 100 μg
| Study group | Role | What they receive |
|---|---|---|
| phenylephrine | Active comparator | Spinal anesthesia with bupivacaine, sufentanil and morphine will be performed and prophylactic infusion of phenylephrine started at an initial rate of 0,5mcg/kg/ min. The rate will be adjusted according to maternal systolic blood pressure. Receives: Drug: Phenylephrine |
| Norepinephrine | Experimental | Spinal anesthesia with bupivacaine, sufentanil and morphine will be performed and prophylactic infusion of norepinephrine tartrate started at an initial rate of 0,1mcg/kg/min. The rate will be adjusted according to maternal systolic blood pressure. Receives: Drug: Norepinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac output maintenance (measured in L/min by bioreactance).
Cardiac output values were analyses at eight points
- Baseline measurement: patient placed in the supine position with the table tilted 10° left, before spinal anesthesia
- Seven measurements at regular intervals: first measurement just after administration of spinal anesthesia in supine position with the table tilted 10° left and last measurement at umbilical cord clamping.
Measured: 5 minutes before the induction of spinal anesthesia until umbilical cord clamping.
Secondary outcomes (31)
Heart rate
number of heart beats per minute
Measured: From induction of spinal anesthesia until weaning of vasopressor
Systolic blood pressure
Systolic blood pressure measured in mmHg
Measured: From induction of spinal anesthesia until weaning of vasopressor
Mean blood pressure
Mean blood pressure measured in mmHg
Measured: From induction of spinal anesthesia until weaning of vasopressor
Duration of bradycardia
Cumulative time in minutes with heart rate less than 60 beats/min
Measured: From induction of spinal anesthesia until weaning of vasopressor]
Duration of hypotension with Mean blood pressure less than 65mmHg
Cumulative time in minutes
Measured: after applying spinal anesthesia until weaning of vasopressor
Duration of hypotension with Systolic Blood Pressure less than 80mmHg
Cumulative time in minutes
Measured: after applying spinal anesthesia until weaning of vasopressor
Duration of hypertension
Cumulative time in minutes with Systolic Blood Pressure more than 140mmHg
Measured: after applying spinal anesthesia until weaning of vasopressor
Cardiac Output
Measured in L/min
Measured: after applying spinal anesthesia until weaning of vasopressor
Stroke Volume
Measured in ml/beat
Measured: after applying spinal anesthesia until weaning of vasopressor
Total Peripheral Resistance
Measured in dynes.sec.cm-5
Measured: after applying spinal anesthesia until weaning of vasopressor
Maximum flow rate of study drug given
Measured in mcg/hour
Measured: after applying spinal anesthesia until weaning of vasopressor
Total dose of study drug consumed
Total dose of study drug given from induction of spinal anesthesia to delivery of the fetus
Measured: after applying spinal anesthesia until weaning of vasopressor
Total Rescue Bolus Dose of atropine to maintain Systolic Blood Pressure
Total dose of atropine administered (mg)
Measured: after applying spinal anesthesia until weaning of vasopressor
Total Rescue Bolus Dose of ephedrine or other vasopressor to maintain Systolic Blood Pressure
Total dose of ephedrine or other vasopressor administered (mg)
Measured: after applying spinal anesthesia until weaning of vasopressor
Incidence of nausea or vomiting
The percentage of patients with nausea or vomiting (at least one episode)
Measured: after applying spinal anesthesia until weaning of vasopressor
Incidence of dizziness or malaise
The percentage of patients with dizziness or malaise (at least one episode)
Measured: after applying spinal anesthesia until weaning of vasopressor
Maternal blood glucose concentration
concentration measured in mmol/l
Measured: at peripheral intravenous line placement
Maternal blood glucose concentration
concentration measured in mmol/l
Measured: at umbilical cord clamping
APGAR score
APGAR score of the fetus ranging from 0 to 10
Measured: 1 minute after delivery
APGAR score
APGAR score of the fetus ranging from 0 to 10
Measured: 3 minutes after delivery
APGAR score
APGAR score of the fetus ranging from 0 to 10
Measured: 5 minutes after delivery
APGAR score
APGAR score of the fetus ranging from 0 to 10
Measured: 10 minutes after delivery
Umbilical arterial potential hydrogen
potential hydrogen in the blood sample obtained from umbilical artery scaled from 1 to 14
Measured: At time of birth
Fetal lactates
from umbilical artery blood sample, measured in mmol/l
Measured: At time of birth
Umbilical arterial partial pressure of carbon dioxide
in the blood sample obtained from umbilical artery measured in mmHg
Measured: At time of birth
Umbilical arterial partial pressure of oxygen
in the blood sample obtained from umbilical artery measured in mmHg
Measured: At time of birth
Umbilical arterial base excess
in the blood sample obtained from umbilical artery measured in mmol/L
Measured: At time of birth
Fetal blood glucose concentration at birth
from umbilical artery blood sample, measured in mmol/l
Measured: At time of birth
Neonatal blood glucose concentration
Capillary blood glucose is measured in mmol/l
Measured: at 1 hour after birth
Uterine and umbilical arteries Doppler with measurement of the pulsatility
pulsatility index of Gosling (peak systolic velocity - end diastolic velocity /mean velocity)
Measured: 5 minutes before realization of spinal anesthesia
Uterine and umbilical arteries Doppler with measurement of the pulsatility
pulsatility index of Gosling (peak systolic velocity - end diastolic velocity /mean velocity)
Measured: 5 minutes after induction of spinal anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start27 Feb 2019
- Primary completion2 Dec 2020
- Study completion2 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Cesarean Section ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier BELIN, Dr, Principal investigator, CHR d'Orléans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03849508
- Sponsor's protocol ID
- CHRO-2018-10
- Acronym
- PHENAD
- Status last verified
- May 2021
- First submitted
- 4 Feb 2019
- Last updated
- 27 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mercier FJ, Auge M, Hoffmann C, Fischer C, Le Gouez A. Maternal hypotension during spinal anesthesia for caesarean delivery. Minerva Anestesiol. 2013 Jan;79(1):62-73. Epub 2012 Nov 18.
PubMed 23135692Langesaeter 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 21415724Kinsella 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 29090733Chooi C, Cox JJ, Lumb RS, Middleton P, Chemali M, Emmett RS, Simmons SW, Cyna AM. Techniques for preventing hypotension during spinal anaesthesia for caesarean section. Cochrane Database Syst Rev. 2017 Aug 4;8(8):CD002251. doi: 10.1002/14651858.CD002251.pub3.
PubMed 28976555Stewart A, Fernando R, McDonald S, Hignett R, Jones T, Columb M. The dose-dependent effects of phenylephrine for elective cesarean delivery under spinal anesthesia. Anesth Analg. 2010 Nov;111(5):1230-7. doi: 10.1213/ANE.0b013e3181f2eae1. Epub 2010 Sep 14.
PubMed 20841418Ngan Kee WD. The use of vasopressors during spinal anaesthesia for caesarean section. Curr Opin Anaesthesiol. 2017 Jun;30(3):319-325. doi: 10.1097/ACO.0000000000000453.
PubMed 28277383Vallejo MC, Attaallah AF, Elzamzamy OM, Cifarelli DT, Phelps AL, Hobbs GR, Shapiro RE, Ranganathan P. An open-label randomized controlled clinical trial for comparison of continuous phenylephrine versus norepinephrine infusion in prevention of spinal hypotension during cesarean delivery. Int J Obstet Anesth. 2017 Feb;29:18-25. doi: 10.1016/j.ijoa.2016.08.005. Epub 2016 Aug 28.
PubMed 27720613Ngan Kee WD, Lee SWY, Ng FF, Khaw KS. Prophylactic Norepinephrine Infusion for Preventing Hypotension During Spinal Anesthesia for Cesarean Delivery. Anesth Analg. 2018 Jun;126(6):1989-1994. doi: 10.1213/ANE.0000000000002243.
PubMed 28678073McLaughlin K, Wright SP, Kingdom JCP, Parker JD. Clinical Validation of Non-Invasive Cardiac Output Monitoring in Healthy Pregnant Women. J Obstet Gynaecol Can. 2017 Nov;39(11):1008-1014. doi: 10.1016/j.jogc.2017.02.015. Epub 2017 Jul 18.
PubMed 28733057Belin O, Casteres C, Alouini S, Le Pape M, Dupont A, Boulain T. Manually Controlled, Continuous Infusion of Phenylephrine or Norepinephrine for Maintenance of Blood Pressure and Cardiac Output During Spinal Anesthesia for Cesarean Delivery: A Double-Blinded Randomized Study. Anesth Analg. 2023 Mar 1;136(3):540-550. doi: 10.1213/ANE.0000000000006244. Epub 2022 Oct 24.
PubMed 36279409
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Controlled Clinical Trial for Comparison of Continuous Phenylephrine Versus Norepinephrine Infusion for Maintenance of Hemodynamic Stability During Cesarean Section Under Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT03849508
- Acronym / sponsor ID
- PHENAD / CHRO-2018-10
- Conditions
- Cesarean Section Complications, Spinal Anesthesia
- Keywords
- cesarean section complications, spinal anesthesia, norepinephrine, maternal hemodynamic and cardiac output
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 27 Feb 2019 (actual)
- Primary completion
- 2 Dec 2020 (actual)
- Study completion
- 2 Dec 2020 (actual)
- First posted
- 21 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison between prophylactic continuous variable infusion of phenylephrine (starting dose 0,5mcg/kg/min) and norepinephrine tartrate (starting dose 0,1mcg/kg/min) to prevent hypotension and maintain cardiac output under spinal anesthesia during cesarean delivery.
Detailed description
Maternal hypotension is a frequent complication after spinal anesthesia for cesarean delivery. Many vasopressors have been studied and used, but the perfect vasopressor is yet to be found. Phenylephrine is the most common used in obstetric anesthesia but its cardiac depressant activity, being an only alpha-adrenergic agonistic, is linked to frequent side effects such as bradycardia and decreased cardiac output.
Norepinephrine is a vasopressor characterized by both alpha and minor beta-adrenergic agonistic activity, it has then a minimal cardiac depressant activity. Hence it would provide a better stability of hemodynamic and cardiac output, and appears as a better alternative to phenylephrine.
In this study, the investigators will compare prophylactic continuous variable infusion of both vasopressors. Phenylephrine started at the dose of 0,5mcg/kg/min and Norepinephrine tartrate started at the dose of 0,1mcg/kg/min. The doses will be adjusted according to maternal systolic blood pressure in order to prevent hypotension (defined by a systolic blood pressure under 80% of baseline).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| phenylephrine | Active comparator | Drug: PhenylephrineSpinal anesthesia with bupivacaine, sufentanil and morphine will be performed and prophylactic infusion of phenylephrine started at an initial rate of 0,5mcg/kg/ min. The rate will be adjusted according to maternal systolic blood pressure. |
| Norepinephrine | Experimental | Drug: NorepinephrineSpinal anesthesia with bupivacaine, sufentanil and morphine will be performed and prophylactic infusion of norepinephrine tartrate started at an initial rate of 0,1mcg/kg/min. The rate will be adjusted according to maternal systolic blood pressure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pregnancy higher than 36 weeks of amenorrhea
- Scheduled or semi-urgent (interval between decision and delivery by cesarean section higher than 12hours) cesarean section under spinal anesthesia
Key exclusion criteria (16 listed)
- Extreme height (less than 140cm; higher than 180cm)
- Weight less than 50kg
- Weight higher than 120kg
- Cardiovascular disease with use of cardiac medication (including antihypertensive drug)
- Active neurological disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NorepinephrineDrug: Norepinephrine Norepinephrine tartrate variable infusion with a starting rate of 0,1μg/kg/min (equivalent to norepinephrine base of 0.05 μg /Kg/min). Other name: Noradrenaline Drug: Hyperbaric Bupivacaine will be injected in the subarachnoid space with a dose of 8 to 12 mg adjusted according to height Drug: Sufentanil will be injected in the subarachnoid space with a dose of 2,5μg Drug: Morphine will be injected in the subarachnoid space with a dose of 100 μg | Drug | Norepinephrine |
| PhenylephrineDrug: Phenylephrine variable infusion with a starting rate of 0,5μg/kg/min Drug: Hyperbaric Bupivacaine will be injected in the subarachnoid space with a dose of 8 to 12 mg adjusted according to height Drug: Sufentanil will be injected in the subarachnoid space with a dose of 2,5μg Drug: Morphine will be injected in the subarachnoid space with a dose of 100 μg | Drug | phenylephrine |
Primary outcome
Cardiac output maintenance (measured in L/min by bioreactance).
Time frame: 5 minutes before the induction of spinal anesthesia until umbilical cord clamping.
Cardiac output values were analyses at eight points * Baseline measurement: patient placed in the supine position with the table tilted 10° left, before spinal anesthesia * Seven measurements at regular intervals: first measurement just after administration of spinal anesthesia in supine position with the table tilted 10° left and last measurement at umbilical cord clamping.
31 secondary outcomes
Heart rate
Time frame: From induction of spinal anesthesia until weaning of vasopressor
Systolic blood pressure
Time frame: From induction of spinal anesthesia until weaning of vasopressor
Mean blood pressure
Time frame: From induction of spinal anesthesia until weaning of vasopressor
Duration of bradycardia
Time frame: From induction of spinal anesthesia until weaning of vasopressor]
Duration of hypotension with Mean blood pressure less than 65mmHg
Time frame: after applying spinal anesthesia until weaning of vasopressor
Duration of hypotension with Systolic Blood Pressure less than 80mmHg
Time frame: after applying spinal anesthesia until weaning of vasopressor
Duration of hypertension
Time frame: after applying spinal anesthesia until weaning of vasopressor
Cardiac Output
Time frame: after applying spinal anesthesia until weaning of vasopressor
Stroke Volume
Time frame: after applying spinal anesthesia until weaning of vasopressor
Total Peripheral Resistance
Time frame: after applying spinal anesthesia until weaning of vasopressor
Maximum flow rate of study drug given
Time frame: after applying spinal anesthesia until weaning of vasopressor
Total dose of study drug consumed
Time frame: after applying spinal anesthesia until weaning of vasopressor
Total Rescue Bolus Dose of atropine to maintain Systolic Blood Pressure
Time frame: after applying spinal anesthesia until weaning of vasopressor
Total Rescue Bolus Dose of ephedrine or other vasopressor to maintain Systolic Blood Pressure
Time frame: after applying spinal anesthesia until weaning of vasopressor
Incidence of nausea or vomiting
Time frame: after applying spinal anesthesia until weaning of vasopressor
Incidence of dizziness or malaise
Time frame: after applying spinal anesthesia until weaning of vasopressor
Maternal blood glucose concentration
Time frame: at peripheral intravenous line placement
Maternal blood glucose concentration
Time frame: at umbilical cord clamping
APGAR score
Time frame: 1 minute after delivery
APGAR score
Time frame: 3 minutes after delivery
APGAR score
Time frame: 5 minutes after delivery
APGAR score
Time frame: 10 minutes after delivery
Umbilical arterial potential hydrogen
Time frame: At time of birth
Fetal lactates
Time frame: At time of birth
Umbilical arterial partial pressure of carbon dioxide
Time frame: At time of birth
Umbilical arterial partial pressure of oxygen
Time frame: At time of birth
Umbilical arterial base excess
Time frame: At time of birth
Fetal blood glucose concentration at birth
Time frame: At time of birth
Neonatal blood glucose concentration
Time frame: at 1 hour after birth
Uterine and umbilical arteries Doppler with measurement of the pulsatility
Time frame: 5 minutes before realization of spinal anesthesia
Uterine and umbilical arteries Doppler with measurement of the pulsatility
Time frame: 5 minutes after induction of spinal anesthesia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2021.
- Background: PubMed 23135692Mercier FJ, Auge M, Hoffmann C, Fischer C, Le Gouez A. Maternal hypotension during spinal anesthesia for caesarean delivery. Minerva Anestesiol. 2013 Jan;79(1):62-73. Epub 2012 Nov 18.
- Background: PubMed 21415724Langesaeter 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.
- Background: PubMed 29090733Kinsella 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.
- Background: PubMed 28976555Chooi C, Cox JJ, Lumb RS, Middleton P, Chemali M, Emmett RS, Simmons SW, Cyna AM. Techniques for preventing hypotension during spinal anaesthesia for caesarean section. Cochrane Database Syst Rev. 2017 Aug 4;8(8):CD002251. doi: 10.1002/14651858.CD002251.pub3.
- Background: PubMed 20841418Stewart A, Fernando R, McDonald S, Hignett R, Jones T, Columb M. The dose-dependent effects of phenylephrine for elective cesarean delivery under spinal anesthesia. Anesth Analg. 2010 Nov;111(5):1230-7. doi: 10.1213/ANE.0b013e3181f2eae1. Epub 2010 Sep 14.
- Background: PubMed 28277383Ngan Kee WD. The use of vasopressors during spinal anaesthesia for caesarean section. Curr Opin Anaesthesiol. 2017 Jun;30(3):319-325. doi: 10.1097/ACO.0000000000000453.
- Background: PubMed 27720613Vallejo MC, Attaallah AF, Elzamzamy OM, Cifarelli DT, Phelps AL, Hobbs GR, Shapiro RE, Ranganathan P. An open-label randomized controlled clinical trial for comparison of continuous phenylephrine versus norepinephrine infusion in prevention of spinal hypotension during cesarean delivery. Int J Obstet Anesth. 2017 Feb;29:18-25. doi: 10.1016/j.ijoa.2016.08.005. Epub 2016 Aug 28.
- Background: PubMed 28678073Ngan Kee WD, Lee SWY, Ng FF, Khaw KS. Prophylactic Norepinephrine Infusion for Preventing Hypotension During Spinal Anesthesia for Cesarean Delivery. Anesth Analg. 2018 Jun;126(6):1989-1994. doi: 10.1213/ANE.0000000000002243.
- Background: PubMed 28733057McLaughlin K, Wright SP, Kingdom JCP, Parker JD. Clinical Validation of Non-Invasive Cardiac Output Monitoring in Healthy Pregnant Women. J Obstet Gynaecol Can. 2017 Nov;39(11):1008-1014. doi: 10.1016/j.jogc.2017.02.015. Epub 2017 Jul 18.
- Derived from this study: PubMed 36279409Belin O, Casteres C, Alouini S, Le Pape M, Dupont A, Boulain T. Manually Controlled, Continuous Infusion of Phenylephrine or Norepinephrine for Maintenance of Blood Pressure and Cardiac Output During Spinal Anesthesia for Cesarean Delivery: A Double-Blinded Randomized Study. Anesth Analg. 2023 Mar 1;136(3):540-550. doi: 10.1213/ANE.0000000000006244. Epub 2022 Oct 24.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier BELIN, Dr principal investigator
CHR d'Orléans
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Norepinephrine and Phenylephrine in people with Cesarean Section Complications and Spinal Anesthesia, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
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 2 inclusion and 16 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 27 May 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 France. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Cardiac output maintenance (measured in L/min by bioreactance). (time frame: 5 minutes before the induction of spinal anesthesia until umbilical cord clamping.). 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 NCT03849508, which also lists 10 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 27 May 2021.