Phenylephrine Versus Norepinephrine for Maintenance of Hemodynamic During Cesarean Section Under Spinal Anesthesia

NCT03849508 | Completed Phase 4

• 1 other identifier: CHRO-2018-10
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cesarean Section Complications; Spinal Anesthesia

Keywords

cesarean section complications; spinal anesthesia; norepinephrine; maternal hemodynamic and cardiac output

Outcome Measures

Primary Outcomes (1)

• 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.

  5 minutes before the induction of spinal anesthesia until umbilical cord clamping.

Secondary Outcomes (31)

• Heart rate

  From induction of spinal anesthesia until weaning of vasopressor

• Systolic blood pressure

  From induction of spinal anesthesia until weaning of vasopressor

• Mean blood pressure

  From induction of spinal anesthesia until weaning of vasopressor

• Duration of bradycardia

  From induction of spinal anesthesia until weaning of vasopressor]

• Duration of hypotension with Mean blood pressure less than 65mmHg

  after applying spinal anesthesia until weaning of vasopressor

Study Arms (2)

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.

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.

Drug: Norepinephrine

Interventions

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

Norepinephrine

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

phenylephrine

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead

Study Sites (1)

Regional Hospital Center of ORLEANS

Orléans, 45067, France

Location

Related Publications (10)

• 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.

  PMID: 23135692 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.

  PMID: 21415724 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.

  PMID: 29090733 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.

  PMID: 28976555 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.

  PMID: 20841418 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.

  PMID: 28277383 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.

  PMID: 27720613 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.

  PMID: 28678073 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.

  PMID: 28733057 BACKGROUND

• 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.

  PMID: 36279409 DERIVED

MeSH Terms

Interventions

Norepinephrine; Phenylephrine

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Olivier BELIN, Dr

  CHR d'Orléans

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2019
• First Posted: February 21, 2019
• Study Start: February 27, 2019
• Primary Completion: December 2, 2020
• Study Completion: December 2, 2020
• Last Updated: May 27, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)