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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Norepinephrine | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac output maintenance (measured in L/min by bioreactance). | Cardiac output values were analyses at eight points
| 5 minutes before the induction of spinal anesthesia until umbilical cord clamping. |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate | number of heart beats per minute | From induction of spinal anesthesia until weaning of vasopressor |
| Systolic blood pressure | Systolic blood pressure measured in mmHg |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olivier BELIN, Dr | CHR d'Orléans | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regional Hospital Center of ORLEANS | Orléans | 45067 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23135692 | Background | 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. | |
| 21415724 | Background | 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. |
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| ID | Term |
|---|---|
| D009638 | Norepinephrine |
| D010656 | Phenylephrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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|
| Phenylephrine | Drug | 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 |
|
| From induction of spinal anesthesia until weaning of vasopressor |
| Mean blood pressure | Mean blood pressure measured in mmHg | From induction of spinal anesthesia until weaning of vasopressor |
| Duration of bradycardia | Cumulative time in minutes with heart rate less than 60 beats/min | From induction of spinal anesthesia until weaning of vasopressor] |
| Duration of hypotension with Mean blood pressure less than 65mmHg | Cumulative time in minutes | after applying spinal anesthesia until weaning of vasopressor |
| Duration of hypotension with Systolic Blood Pressure less than 80mmHg | Cumulative time in minutes | after applying spinal anesthesia until weaning of vasopressor |
| Duration of hypertension | Cumulative time in minutes with Systolic Blood Pressure more than 140mmHg | after applying spinal anesthesia until weaning of vasopressor |
| Cardiac Output | Measured in L/min | after applying spinal anesthesia until weaning of vasopressor |
| Stroke Volume | Measured in ml/beat | after applying spinal anesthesia until weaning of vasopressor |
| Total Peripheral Resistance | Measured in dynes.sec.cm-5 | after applying spinal anesthesia until weaning of vasopressor |
| Maximum flow rate of study drug given | Measured in mcg/hour | 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 | 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) | 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) | 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) | 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) | after applying spinal anesthesia until weaning of vasopressor |
| Maternal blood glucose concentration | concentration measured in mmol/l | at peripheral intravenous line placement |
| Maternal blood glucose concentration | concentration measured in mmol/l | at umbilical cord clamping |
| APGAR score | APGAR score of the fetus ranging from 0 to 10 | 1 minute after delivery |
| APGAR score | APGAR score of the fetus ranging from 0 to 10 | 3 minutes after delivery |
| APGAR score | APGAR score of the fetus ranging from 0 to 10 | 5 minutes after delivery |
| APGAR score | APGAR score of the fetus ranging from 0 to 10 | 10 minutes after delivery |
| Umbilical arterial potential hydrogen | potential hydrogen in the blood sample obtained from umbilical artery scaled from 1 to 14 | At time of birth |
| Fetal lactates | from umbilical artery blood sample, measured in mmol/l | At time of birth |
| Umbilical arterial partial pressure of carbon dioxide | in the blood sample obtained from umbilical artery measured in mmHg | At time of birth |
| Umbilical arterial partial pressure of oxygen | in the blood sample obtained from umbilical artery measured in mmHg | At time of birth |
| Umbilical arterial base excess | in the blood sample obtained from umbilical artery measured in mmol/L | At time of birth |
| Fetal blood glucose concentration at birth | from umbilical artery blood sample, measured in mmol/l | At time of birth |
| Neonatal blood glucose concentration | Capillary blood glucose is measured in mmol/l | 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) | 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) | 5 minutes after induction of spinal anesthesia |
| 29090733 | Background | 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. |
| 28976555 | Background | Chooi 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. |
| 20841418 | Background | Stewart 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. |
| 28277383 | Background | Ngan 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. |
| 27720613 | Background | Vallejo 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. |
| 28678073 | Background | Ngan 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. |
| 28733057 | Background | McLaughlin 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. |
| 36279409 | Derived | Belin 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. |
| D000588 |
| Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |