Skip to main content
Clinical Trials/NCT07363109
NCT07363109Not yet recruitingNot Applicable

Prevention of Hypotension During Elective Cesarean Section Under Spinal Anaesthesia With Fixed-rate Metaraminol Infusion Versus Fixed-rate Norepinephrine Infusion: A Double-blind Randomised Controlled Clinical Trial.

Aretaieion University Hospital0 sites80 target enrollmentStarted: February 1, 2026Last updated:
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
80
Primary Endpoint
incidence of hypotension

Study Overview

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.

Detailed Description

Spinal anaesthesia is the anaesthetic technique of choice for elective cesarean section.

Spinal anaesthesia can be complicated by hypotension, with incidence exceeding 80% occasionally. Hypotension can lead to nausea, emesis and a subjective feeling of discomfort due to cerebral hypoperfusion. If left untreated, severe or sustained hypotension can lead to decreased uteroplacental flow and fetal distress of premature or compromised fetuses while severe complications to the parturient might ensue, such as loss of consciousness, aspiration, apnea or cardiac arrest.

Prophylactic vasoconstrictor infusion is an effective strategy for preventing maternal hypotension during regional anaesthesia. Phenylephrine is widely used because it acts quickly and causes less neonatal acidosis than ephedrine, but high doses may reduce maternal cardiac output. Norepinephrine and metaraminol, a sympathomimetic amine that acts both directly and indirectly, mainly by stimulating alpha-1-adrenergic receptors, with a weak effect on beta-receptors, have emerged as potential alternatives. While the optimal norepinephrine infusion dose has been defined in several studies, research on metaraminol remains limited, with insufficient data on its ideal dosing and efficacy in obstetrics. Most comparative studies evaluate metaraminol against phenylephrine-some suggesting better fetal acid-base outcomes-but no studies directly compare metaraminol with norepinephrine. Further research is therefore needed before metaraminol can be routinely recommended in obstetric anaesthesia.

This study will include pregnant adults who are normotensive, without complications, with a single pregnancy, who are not in active labor, and who are scheduled to undergo an elective cesarean section at the Gynecology-Obstetrics Clinic of Aretaieion Hospital.The study will use randomized, concealed allocation to assign participants to receive either metaraminol or norepinephrine infusions. Study group allocation will take place according to a computer-generated sequence of random numbers. A non-involved healthcare professional will reveal each participant's assignment, and a nurse will prepare identical 50 mL syringes labeled "study infusion," containing the drug at concentrations that deliver either 100 µg/min (200 µg/mL at 30 mL/h) of metaraminol or 4 µg/min (8 µg/mL at 30 mL/h) of norepinephrine. The anaesthesiologist, patient, and data analyst will remain blinded to group allocation.

All parturients will receive standard pre-anesthetic evaluation and standard hemodynamic monitoring will be applied. Next, on the hand opposite the one with the cuff for measuring NIBP, a special finger cuff connected to the Edwards Lifesciences ClearSight system will be placed on the index, middle, or ring finger. The ClearSight system from Edwards Lifesciences is a non-invasive medical system that allows continuous monitoring of blood pressure (cBP), as well as a range of other hemodynamic parameters such as cardiac output (CO), stroke volume (SV), and systemic vascular resistance (SVR).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 48 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • adult parturients, singleton gestation, elective cesarean section

Exclusion Criteria

  • 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

Arms & Interventions

Metaraminol group

Active Comparator

Intervention: Metaraminol infusion (Procedure)

Norepinephrine group

Active Comparator

Intervention: Norepinephrine infusion (Procedure)

Outcomes

Primary Outcomes

incidence of hypotension

Time Frame: intraoperative

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

number of hypotensive episodes in the pregnant woman

Time Frame: intraoperativre

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

incidence of bradycardia

Time Frame: intraoperative

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

Secondary Outcomes

  • 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)
  • incidence of hypertension(intraoperative)
  • need for differentiation in the basic infusion rate of the vasopressor solution(intraoperative)
  • incidence of nausea/vomiting(intraoperative)
  • Incidence of dizziness, discomfort, and shivering(intraoperative)
  • neonatal Apgar score(1 min and 5 min post delivery)
  • neonatal blood gases(1 min post delivery)
  • glucose in neonatal blood(1 min post delivery)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Adamantia Gkaniou

Resident anaesthesiologist, MD, MSc

Aretaieion University Hospital

Similar Trials