Carbetocin on Myocardial Repolarization Dynamics in Obstetrics Study

Cardiac Arrythmias Clinical Trial

— CaRDIO  

Official title:

The Effect of Carbetocin Dose on Dispersion of Myocardial Repolarization in Healthy Parturients Scheduled for Elective Cesarean Delivery Under Spinal Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03716076
• Other study ID #: H18-02232
• Status: Completed
• Phase: Phase 4
• Start date: November 1, 2018
• Est. completion date: April 24, 2020

Study information

• Verified date: April 2021
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 24, 2020
• Est. primary completion date: June 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrythmias

Intervention

Drug:
• Carbetocin
50 mcg or 100 mcg bolus of carbetocin

Locations

Country	Name	City	State
Canada	BC Women's Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tp-e	Time interval between peak and end of T-wave (Tp-e)	5 minutes post-carbetocin administration
Secondary	Arrhythmia	Occurrence of Atrial or Ventricular Arrhythmias	perioperatively, typically ranging 30 minutes-1 hour
Secondary	QTc at 5 Min	Bazette corrected Q-T interval	5 min post-carbetocin administration
Secondary	QTc 10 Min	Bazette corrected Q-T interval (QTc)	10 minutes post-carbetocin administration
Secondary	QTc 5 Min Spinal	Bazette corrected Q-T interval change after spinal anesthesia	5 min post-administration of spinal anesthesia
Secondary	Tp-e 5 Min Post-spinal	Time between peak and end of T-wave,	5 minutes after administration of spinal anesthesia
Secondary	Tp-e at 10 Min	Time between peak and end of T-wave	10 minutes post-carbetocin administration