Carbetocin on Myocardial Repolarization Dynamics in Obstetrics Study

Study Overview
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Brief Summary
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Relationship between carbetocin dose on transmural dispersion of repolarization (TDR).

Detailed Description
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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

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

Conditions
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Cardiac Arrythmias

Intervention / Treatment
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* Drug: Carbetocin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participant receives 50 mcg of carbetocin post-delivery.<br>Participant receives 50 mcg of carbetocin post-delivery. | Drug: Carbetocin<br>* 50 mcg or 100 mcg bolus of carbetocin<br>|
| Experimental: Participant receives 100 mcg of carbetocin post-delivery.<br>Participant receives 100 mcg of carbetocin post-delivery. | Drug: Carbetocin<br>* 50 mcg or 100 mcg bolus of carbetocin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tp-e | Time interval between peak and end of T-wave (Tp-e) | 5 minutes post-carbetocin administration | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carbetocin, Myocardial repolarization