NCT07363109

Brief Summary

The aim of this double-blind randomised study will be to compare a fixed-rate prophylactic metaraminol infusion to a fixed-rate prophylactic norepinephrine infusion during elective cesarean section under combined spinal-epidural anaesthesia.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
34mo left

Started Feb 2026

Typical duration for not_applicable

Status
not yet recruiting

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 Progress9%
Feb 2026Mar 2029

First Submitted

Initial submission to the registry

January 15, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2029

Expected
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

3 years

First QC Date

January 15, 2026

Last Update Submit

January 15, 2026

Conditions

Hypotension During Cesarean DeliveryHypotension After Spinal Anesthesia

Keywords

metaraminolnorepinephrineprevention of hypotensioncesarean sectionmaternal hemodynamics

Outcome Measures

Primary Outcomes (3)

  • incidence of hypotension

    any occurrence of hypotension throughout the operation will be recorded (SAP \< 80% of baseline)

    intraoperative

  • number of hypotensive episodes in the pregnant woman

    the number of hypotensive episodes (SAP \< 80% of baseline)throughout the operation will be recorded

    intraoperativre

  • incidence of bradycardia

    any incidence of HR \< 60/min will be recorded

    intraoperative

Secondary Outcomes (12)

  • need for vasoconstrictor

    intraoperative

  • type of bolus vasopressor administered

    intraoperative

  • number of bolus doses of vasoconstrictor administered

    intraoperative

  • total dose of vasoconstrictor administered

    intraoperative

  • need for administration of atropine

    intraoperative

  • +7 more secondary outcomes

Study Arms (2)

Metaraminol group

ACTIVE COMPARATOR
Procedure: Metaraminol infusion

Norepinephrine group

ACTIVE COMPARATOR
Procedure: Norepinephrine infusion

Interventions

Metaraminol infusionPROCEDURE

In parturients allocated to the metaraminol group, a metaraminol infusion (30 mL/h corresponding to 100 μg/min) will be initiated as soon as spinal anaesthesia is established.

Metaraminol group
Norepinephrine infusionPROCEDURE

In parturients allocated to the norepinephrine group, a norepinephrine infusion (30 mL/h corresponding to 4 μg/min) will be initiated as soon as spinal anaesthesia is established.

Norepinephrine group

Eligibility Criteria

Age18 Years - 48 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • adult parturients, singleton gestation, elective cesarean section

You may not qualify if:

  • ASA \>II, age \<18 years, 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, emergency CT, cardiovascular disease or cerebrovascular disease, pre-existing or pregnancy-induced hypertension, use of antihypertensive medication during pregnancy, preeclampsia, any contraindication for regional anesthesia, such as thrombocytopenia or coagulation disorder, communication or language barriers, lack of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (16)

  • McDonnell NJ, Paech MJ, Muchatuta NA, Hillyard S, Nathan EA. A randomised double-blind trial of phenylephrine and metaraminol infusions for prevention of hypotension during spinal and combined spinal-epidural anaesthesia for elective caesarean section. Anaesthesia. 2017 May;72(5):609-617. doi: 10.1111/anae.13836. Epub 2017 Mar 3.

    PMID: 28255987BACKGROUND

  • Chao E, Sun HL, Huang SW, Liao JH, Ma PL, Chen HC. Metaraminol use during spinal anaesthesia for caesarean section: a meta-analysis of randomised controlled trials. Int J Obstet Anesth. 2019 Aug;39:42-50. doi: 10.1016/j.ijoa.2019.01.009. Epub 2019 Jan 25.

    PMID: 30772119BACKGROUND

  • Lyu W, Zhang Z, Li C, Wei P, Feng H, Zhou H, Zheng Q, Zhou J, Li J. Intravenous initial bolus during prophylactic norepinephrine infusion to prevent spinal hypotension for cesarean delivery: A randomized controlled, dose-finding trial. J Clin Anesth. 2024 Oct;97:111562. doi: 10.1016/j.jclinane.2024.111562. Epub 2024 Jul 23.

    PMID: 39047530BACKGROUND

  • Xiao F, Xu WP, Yao HQ, Fan JM, Chen XZ. A Randomized Double-Blinded Dose-dependent Study of Metaraminol for Preventing Spinal-Induced Hypotension in Caesarean Delivery. Front Pharmacol. 2021 May 12;12:608198. doi: 10.3389/fphar.2021.608198. eCollection 2021.

    PMID: 34054513BACKGROUND

  • Ngan Kee WD, Khaw KS, Ng FF. Comparison of phenylephrine infusion regimens for maintaining maternal blood pressure during spinal anaesthesia for Caesarean section. Br J Anaesth. 2004 Apr;92(4):469-74. doi: 10.1093/bja/aeh088. Epub 2004 Feb 20.

    PMID: 14977792BACKGROUND

  • 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.

    PMID: 20173633BACKGROUND

  • Fitzgerald JP, Fedoruk KA, Jadin SM, Carvalho B, Halpern SH. Prevention of hypotension after spinal anaesthesia for caesarean section: a systematic review and network meta-analysis of randomised controlled trials. Anaesthesia. 2020 Jan;75(1):109-121. doi: 10.1111/anae.14841. Epub 2019 Sep 18.

    PMID: 31531852BACKGROUND

  • Bower JR, Kinsella SM. Preventing and treating hypotension during spinal anaesthesia for caesarean section. BJA Educ. 2020 Nov;20(11):360-361. doi: 10.1016/j.bjae.2020.08.001. Epub 2020 Sep 9. No abstract available.

    PMID: 33456918BACKGROUND

  • Gizzo S, Di Gangi S, Noventa M, Bacile V, Zambon A, Nardelli GB. Women's choice of positions during labour: return to the past or a modern way to give birth? A cohort study in Italy. Biomed Res Int. 2014;2014:638093. doi: 10.1155/2014/638093. Epub 2014 May 15.

    PMID: 24955365BACKGROUND

  • Nguyen-Lu N, Carvalho JC, Kingdom J, Windrim R, Allen L, Balki M. Mode of anesthesia and clinical outcomes of patients undergoing Cesarean delivery for invasive placentation: a retrospective cohort study of 50 consecutive cases. Can J Anaesth. 2016 Nov;63(11):1233-44. doi: 10.1007/s12630-016-0695-x. Epub 2016 Jul 21.

    PMID: 27443374BACKGROUND

  • Kim WH, Hur M, Park SK, Yoo S, Lim T, Yoon HK, Kim JT, Bahk JH. Comparison between general, spinal, epidural, and combined spinal-epidural anesthesia for cesarean delivery: a network meta-analysis. Int J Obstet Anesth. 2019 Feb;37:5-15. doi: 10.1016/j.ijoa.2018.09.012. Epub 2018 Sep 27.

    PMID: 30415797BACKGROUND

  • Theodoraki K, Hadzilia S, Valsamidis D, Stamatakis E. Prevention of hypotension during elective cesarean section with a fixed-rate norepinephrine infusion versus a fixed-rate phenylephrine infusion. Alpha double-blinded randomized controlled trial. Int J Surg. 2020 Dec;84:41-49. doi: 10.1016/j.ijsu.2020.10.006. Epub 2020 Oct 17.

    PMID: 33080415BACKGROUND

  • Sumikura H, Niwa H, Sato M, Nakamoto T, Asai T, Hagihira S. Rethinking general anesthesia for cesarean section. J Anesth. 2016 Apr;30(2):268-73. doi: 10.1007/s00540-015-2099-4. Epub 2015 Nov 19.

    PMID: 26585767BACKGROUND

  • Iddrisu, M., Khan, Z.H. Anesthesia for cesarean delivery: general or regional anesthesia-a systematic review. Ain-Shams J Anesthesiol 13, 1 (2021). https://doi.org/10.1186/s42077-020-00121-7

    BACKGROUND

  • Angolile CM, Max BL, Mushemba J, Mashauri HL. Global increased cesarean section rates and public health implications: A call to action. Health Sci Rep. 2023 May 18;6(5):e1274. doi: 10.1002/hsr2.1274. eCollection 2023 May.

    PMID: 37216058BACKGROUND

  • Ghaffari S, Dehghanpisheh L, Tavakkoli F, Mahmoudi H. The Effect of Spinal versus General Anesthesia on Quality of Life in Women Undergoing Cesarean Delivery on Maternal Request. Cureus. 2018 Dec 11;10(12):e3715. doi: 10.7759/cureus.3715.

    PMID: 30788204BACKGROUND

Study Officials

  • Kassiani Theodoraki

    Aretaieion University Hospital, National and Kapodistrian University of Athens

    STUDY DIRECTOR

Central Study Contacts

Adamantia Gkaniou

CONTACT

00306930386842adamantiagkaniou@gmail.com

Kassiani Theodoraki

CONTACT

00306974634162ktheodoraki@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident anaesthesiologist, MD, MSc

Study Record Dates

First Submitted

January 15, 2026

First Posted

January 23, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

February 1, 2029

Study Completion (Estimated)

March 1, 2029

Last Updated

January 23, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share