Impact of Carbetocin Administration on Heart Rate When Given as an Infusion Versus as a Bolus.

What Was Tested

This registered phase 4 trial tested Carbetocin.

Study plans to enroll 70 adult patients scheduled to undergo elective cesarean delivery under spinal anesthesia.

It had two arms (groups): Carbetocin bolus (active comparator) and Carbetocin infusion (experimental).

The registry classes the interventions as drug.

More on the Plan

In this prospective, randomized and controlled study, each parturient will enter the operating room on the day scheduled for there surgery.

All the classic monitors will be installed, along with the Edwards (Clear sight system).

Baseline measures of BP (blood pressure), HR (Heart Rate), O2 Arterial Saturation will be taken before entering in the operating room, in a calm environment.

The anesthetic technique will be standardized.

Who Took Part

70 actual participants took part.

It was open to women only aged from 18 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Elective caesarean delivery. 37 weeks or more of gestation. ASA status I or II. Patients \> 18 years old. Morbid obesity (BMI \> 40 at first prenatal medical visit).

The full record lists 20 inclusion and 4 exclusion criteria; among the exclusions: patient who receives iv ephedrine or glycopyrrolate during the study period; patient who needs an exteriorization of the uterus for repair following caesarean delivery.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

Random assignment meant chance, not the researchers, decided who got Carbetocin and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Carbetocin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2018-06-11 with completion listed for 2020-01-28.

It ran at 1 site in Canada.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Delta Heart Rate (time frame: From the administration of the drug study every 20 secondes until 20 minutes after the drug injection for each patient).

It also tracked 21 secondary outcomes, for example Delta Stroke Volume, Delta Stroke Volume Variation, Delta Cardiac Output, Delta Systemic Vascular Resistance, Peak value of Heart Rate and Peak value of Stroke Volume.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Carbetocin in 70 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Carbetocin compound page, all human trials.