Carbetocin on Myocardial Repolarization Dynamics in Obstetrics Study

University of British Columbia50 enrolled

Overview

Relationship between carbetocin dose on transmural dispersion of repolarization (TDR).

Carbetocin is a uterotonic used to prevent postpartum hemorrhage. Although it has been proven to be completely safe, little is known about its effects on the electrical activity of the heart. The investigators aim to determine its effect on myocardial repolarization dynamics

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

Conditions

Cardiac Arrythmias

Interventions

CarbetocinDRUG

50 mcg or 100 mcg bolus of carbetocin

Eligibility

Sex: FEMALEMin age: 19 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Pregnant patients ≥ 36 weeks gestation, for elective Cesarean delivery under neuraxial anesthesia * American Society of Anesthesiologists (ASA) class 2 * Patients ≥ 19 years of age Exclusion Criteria: * Long QT syndrome * Cardiac disease or rhythm abnormalities * Family history of long QT syndrome or abnormal cardiac conduction * Currently taking medication that is known to prolong the QT interval * Women who are high risk for uterine atony as outlined in SOGC * Known allergic reaction or hypersensitivity to Carbetocin or any other oxytocin homologue * Patients who are unable to give informed consent because of a language barrier as the study team only speaks English and will be unable to complete consent process and study procedure appropriately.

Locations (1)

BC Women's Hospital

Vancouver, British Columbia, Canada

Outcomes

Primary Outcomes

Tp-e

Time interval between peak and end of T-wave (Tp-e)

Time frame: 5 minutes post-carbetocin administration

Secondary Outcomes

Arrhythmia

Occurrence of Atrial or Ventricular Arrhythmias

Time frame: perioperatively, typically ranging 30 minutes-1 hour

QTc at 5 Min

Bazette corrected Q-T interval

Time frame: 5 min post-carbetocin administration

QTc 10 Min

Bazette corrected Q-T interval (QTc)

Time frame: 10 minutes post-carbetocin administration

QTc 5 Min Spinal

Bazette corrected Q-T interval change after spinal anesthesia

Time frame: 5 min post-administration of spinal anesthesia

Tp-e 5 Min Post-spinal

Time between peak and end of T-wave,

Time frame: 5 minutes after administration of spinal anesthesia

Tp-e at 10 Min

Time between peak and end of T-wave

Time frame: 10 minutes post-carbetocin administration

Data from ClinicalTrials.gov

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