NCT04951167

Brief Summary

There are previous studies in which norepinephrine was administered only as a prophylactic or only infusion to prevent hypotension after spinal anesthesia in cesarean sections. However, there are not enough studies reporting which of these application methods are more effective. Therefore, in our study, cesarean section under spinal anesthesia was planned; We aimed to investigate the effectiveness of norepinephrine differential administration methods on preventing maternal hypotension.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
208

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 6, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

July 6, 2021

Status Verified

July 1, 2021

Enrollment Period

1 year

First QC Date

July 1, 2021

Last Update Submit

July 1, 2021

Conditions

HYPOTENSION AFTER SPINAL ANESTHESIA,IN PREGNANCY

Keywords

NOREPINPHRINESPINAL ANESTHESIAHYPOTENSIONpregnancy

Outcome Measures

Primary Outcomes (1)

  • systolic blood pressure

    When systolic blood pressure drops more than 20% compared to baseline, it will be considered as hypotension

    every 2 mins from intrathecal drug administration until delivery

Study Arms (4)

PB: prophylactic bolus

ACTIVE COMPARATOR

an IV bolus of 4 mcg Norepinephrine will be administered immediately after spinal anesthesia, and then SF infusion will be started at 1 ml/min.

Drug: Norepinephrine

PI:prophylactic infusion

ACTIVE COMPARATOR

1ml of saline is administered immediately after spinal anesthesia, and then infusion will be started with the study drug at 1 ml/min.(4mcg/min)

Drug: Norepinephrine

TB:therapeutic bolus

ACTIVE COMPARATOR

immediately after spinal anesthesia, 1 ml of saline, followed by 1 ml/min infusion of SF, and when the blood pressure decreases by 20%, 1 ml of working solution and then 1 ml/min of saline infusion will be started.

Drug: Norepinephrine

TBI:therapeutic bolus-infusion

ACTIVE COMPARATOR

1 ml of study drug and 1 ml/min of study drug infusion will be started immediately after spinal anesthesia, after 1 ml of saline followed by 1 ml/min of SF infusion when blood pressure decreases by 20% of the entry

Drug: Norepinephrine

Interventions

NorepinephrineDRUG

in the form of infusion

PB: prophylactic bolusTB:therapeutic bolusTBI:therapeutic bolus-infusion

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant women over the age of 18, with ASA (American Society of Anesthesiologists physical status) ≤ III, body weight 50-100 kg and height 150-180 cm, with a single pregnancy planned for cesarean section under elective conditions under spinal anesthesia, will be included in the study.

You may not qualify if:

  • Pregnant women with allergy or hypersensitivity to norepinephrine, pre-existing hypertension or pregnancy-induced hypertension, cardiovascular or cerebrovascular disease, renal failure, history of thrombosis in the mesenteric or peripheral vessels, history of diabetes with known fetal anomalies, users of monoaminooxidase inhibitors, tricyclic antidepressants and those who refused to study were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu Universitesi

Malatya, 44280, Turkey (Türkiye)

Location

Related Publications (8)

  • 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: 29090733BACKGROUND

  • Lee A, Ngan Kee WD, Gin T. A quantitative, systematic review of randomized controlled trials of ephedrine versus phenylephrine for the management of hypotension during spinal anesthesia for cesarean delivery. Anesth Analg. 2002 Apr;94(4):920-6, table of contents. doi: 10.1097/00000539-200204000-00028.

    PMID: 11916798BACKGROUND

  • Habib AS. A review of the impact of phenylephrine administration on maternal hemodynamics and maternal and neonatal outcomes in women undergoing cesarean delivery under spinal anesthesia. Anesth Analg. 2012 Feb;114(2):377-90. doi: 10.1213/ANE.0b013e3182373a3e. Epub 2011 Nov 21.

    PMID: 22104076BACKGROUND

  • Chen D, Qi X, Huang X, Xu Y, Qiu F, Yan Y, Li Y. Efficacy and Safety of Different Norepinephrine Regimens for Prevention of Spinal Hypotension in Cesarean Section: A Randomized Trial. Biomed Res Int. 2018 May 23;2018:2708175. doi: 10.1155/2018/2708175. eCollection 2018.

    PMID: 29951531BACKGROUND

  • Onwochei DN, Ngan Kee WD, Fung L, Downey K, Ye XY, Carvalho JCA. Norepinephrine Intermittent Intravenous Boluses to Prevent Hypotension During Spinal Anesthesia for Cesarean Delivery: A Sequential Allocation Dose-Finding Study. Anesth Analg. 2017 Jul;125(1):212-218. doi: 10.1213/ANE.0000000000001846.

    PMID: 28248702BACKGROUND

  • Ngan Kee WD, Khaw KS, Tan PE, Ng FF, Karmakar MK. Placental transfer and fetal metabolic effects of phenylephrine and ephedrine during spinal anesthesia for cesarean delivery. Anesthesiology. 2009 Sep;111(3):506-12. doi: 10.1097/ALN.0b013e3181b160a3.

    PMID: 19672175BACKGROUND

  • Saravanan S, Kocarev M, Wilson RC, Watkins E, Columb MO, Lyons G. Equivalent dose of ephedrine and phenylephrine in the prevention of post-spinal hypotension in Caesarean section. Br J Anaesth. 2006 Jan;96(1):95-9. doi: 10.1093/bja/aei265. Epub 2005 Nov 25.

    PMID: 16311286BACKGROUND

  • Cooper DW. Caesarean delivery vasopressor management. Curr Opin Anaesthesiol. 2012 Jun;25(3):300-8. doi: 10.1097/ACO.0b013e3283530d62.

    PMID: 22473212BACKGROUND

MeSH Terms

Conditions

Hypotension

Interventions

Norepinephrine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Nurcin Gulhas, Prof

    Inonu Universitesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Pregnant women will be randomly divided into 4 groups using the closed envelope method. The person who prepares the study drugs and follows the study will be different and unaware of the study.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

July 1, 2021

First Posted

July 6, 2021

Study Start

May 15, 2021

Primary Completion

May 15, 2022

Study Completion

August 1, 2022

Last Updated

July 6, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will share

Locations

TU(1)