Prevention of Maternal Hypotension During Cesarean Section With Norepinephrine Infusion.

NCT ID: NCT04406051

Last Updated: 2021-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-26
• Study Completion Date: 2021-04-30

Brief Summary

This will be a randomized study aiming at investigating the combination of a norepinephrine infusion and colloid preloading versus the combination of a norepinephrine infusion and crystalloid co-loading for the prevention of maternal hypotension during elective cesarean section

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. Recently, noradrenaline has been shown to be effective in maintaining blood pressure in obstetric patients. Another technique widely used to prevent hypotension is fluid administration. Current evidence suggests that the combination of fluid administration and vasoconstrictive medications should be the main strategy for prevention and management of hypotension accompanying neuraxial anesthesia procedures during cesarean section. Research is still underway in relation to the most appropriate timing for fluid administration, the most appropriate fluid volume as well as the type of fluid that should be administered. However, preloading of crystalloids seems to be inefficient as a sole strategy, while co-loading of colloids is more effective than co-loading of crystalloids for prevention of hypotension in the parturient. On the other hand, preloading and co-loading of colloids seem to be of equal effectiveness. Literature is rather scarce regarding the comparison of colloid preloading and crystalloid co-loading.

The aim of this randomized study will be to investigate the combination of a norepinephrine infusion and colloid preloading versus the combination of a norepinephrine infusion and crystalloid co-loading for the prevention of maternal hypotension during elective cesarean section.

Conditions

Hypotension; Obstetric Anesthesia Problems; Cesarean Section Complications; Hypotensive; Vasoconstriction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

norepinephrine infusion and colloid preloading (NOR-COL)

in parturients allocated to the NOR-COL group, a norepinephrine infusion will be started as soon as spinal anesthesia is initiated. This group will also receive colloid preloading (5 mL/kg)

Group Type: ACTIVE_COMPARATOR

norepinephrine infusion and colloid preloading (NOR-COL)

Intervention Type: PROCEDURE

in parturients allocated to the NOR-COL group, a norepinephrine infusion will be started as soon as spinal anesthesia is initiated. This group will also receive 5 mL/kg of colloid infusion prior to the initiation of spinal anesthesia

norepinephrine infusion and crystalloid co-loading (NOR-CRYS)

in parturients allocated to the NOR-CRYST group, a norepinephrine infusion will be started as soon as spinal anesthesia is initiated. This group will also receive crystalloid co-loading (10 mL/kg)

Group Type: ACTIVE_COMPARATOR

norepinephrine infusion and crystalloid co-loading (NOR-CRYST)

Intervention Type: PROCEDURE

in parturients allocated to the NOR-CRYST group, a norepinephrine infusion will be started as soon as spinal anesthesia is initiated. This group will also receive 10 mL/kg of crystalloid infusion simultaneously with the initiation of spinal anesthesia

Interventions

norepinephrine infusion and colloid preloading (NOR-COL)

in parturients allocated to the NOR-COL group, a norepinephrine infusion will be started as soon as spinal anesthesia is initiated. This group will also receive 5 mL/kg of colloid infusion prior to the initiation of spinal anesthesia

Intervention Type: PROCEDURE

norepinephrine infusion and crystalloid co-loading (NOR-CRYST)

in parturients allocated to the NOR-CRYST group, a norepinephrine infusion will be started as soon as spinal anesthesia is initiated. This group will also receive 10 mL/kg of crystalloid infusion simultaneously with the initiation of spinal anesthesia

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Body Mass Index (BMI) >40 kg/m2
• Body weight <50 kg
• Body weight>100 kg
• height<150 cm
• height>180 cm
• multiple gestation
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 48 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Alexandra Hospital, Athens, Greece

OTHER

Sponsor Role: collaborator

Aretaieion University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dr Kassiani Theodoraki

Professor of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kassiani Theodoraki, PhD, DESA

Role: PRINCIPAL_INVESTIGATOR

Aretaieion University Hospital

Emmanouil Stamatakis, PhD

Role: PRINCIPAL_INVESTIGATOR

Alexandra General Hospital of Athens

Sofia Hadzilia, MD

Role: PRINCIPAL_INVESTIGATOR

Alexandra General Hospital of Athens

Dimitrios Valsamidis, MD

Role: PRINCIPAL_INVESTIGATOR

Alexandra General Hospital of Athens

Konstantina Kalopita, MD

Role: PRINCIPAL_INVESTIGATOR

Alexandra General Hospital of Athens

Locations

Aretaieion University Hospital

Athens, , Greece

Alexandra General Hospital of Athens

Athens, , Greece

Countries

Greece

References

Afolabi BB, Lesi FE. Regional versus general anaesthesia for caesarean section. Cochrane Database Syst Rev. 2012 Oct 17;10(10):CD004350. doi: 10.1002/14651858.CD004350.pub3.

Reference Type: BACKGROUND

PMID: 23076903 (View on PubMed)

Klohr S, Roth R, Hofmann T, Rossaint R, Heesen M. Definitions of hypotension after spinal anaesthesia for caesarean section: literature search and application to parturients. Acta Anaesthesiol Scand. 2010 Sep;54(8):909-21. doi: 10.1111/j.1399-6576.2010.02239.x. Epub 2010 Apr 23.

Reference Type: BACKGROUND

PMID: 20455872 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20173633 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29090733 (View on PubMed)

Banerjee A, Stocche RM, Angle P, Halpern SH. Preload or coload for spinal anesthesia for elective Cesarean delivery: a meta-analysis. Can J Anaesth. 2010 Jan;57(1):24-31. doi: 10.1007/s12630-009-9206-7. Epub 2009 Oct 27.

Reference Type: BACKGROUND

PMID: 19859776 (View on PubMed)

Mercier FJ. Fluid loading for cesarean delivery under spinal anesthesia: have we studied all the options? Anesth Analg. 2011 Oct;113(4):677-80. doi: 10.1213/ANE.0b013e3182245af4. No abstract available.

Reference Type: BACKGROUND

PMID: 21948275 (View on PubMed)

Li L, Zhang Y, Tan Y, Xu S. Colloid or crystalloid solution on maternal and neonatal hemodynamics for cesarean section: a meta-analysis of randomized controlled trials. J Obstet Gynaecol Res. 2013 May;39(5):932-41. doi: 10.1111/jog.12001. Epub 2013 Feb 4.

Reference Type: BACKGROUND

PMID: 23379937 (View on PubMed)

Other Identifiers

nor-cryst vs. nor-coll

Identifier Type: -

Identifier Source: org_study_id