Cardiac Ischemia, Cesarian Section
Conditions
Keywords
carbetocin, duratocin, cardiac symptoms
Brief summary
The goal of this project is to examine the cardiac symptoms and physiologic changes after administration of a reduced dose of carbetocin in participants undergoing elective cesarian section. * Does reduced dose carbetocin (50mcg) have fewer cardiac side effects than usual dose carbetocin (100mcg) when comparing patient reported symptoms, ECG changes and troponin increases? * Is there a relationship between patient reported cardiac symptoms after carbetocin administration and subjective measures of cardiac ischemia (ECG changes and troponin increases? Researchers will compare 50mcg of carbetocin to the control group of 100mcg of carbetocin in patients undergoing elective cesarian section. Participants will: * Be given 50mcg or 100mcg of carbetocin during cesarian section * Asked to report cardiac symptoms * Be assessed for ECG changes and blood loss using standard of practice monitoring * Have a troponin I blood test completed after delivery
Interventions
DRUGCarbetocin
A uterotonic agent used for the prevention of postpartum hemorrhage in Cesarian section
Sponsors
Jordan Leitch
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Undergoing elective cesarian section * Primary and repeat cesarian section
Exclusion criteria
* Prior and current cardiovascular co-morbidities including pre-eclampsia * BMI greater than 50 * Pre-existing bleeding disorders * Allergy to carbetocin * Age under 18
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient reported symptoms | within 5 minutes of study drug administration | Subjective patient reported symptoms of cardiac ischemia, reported with descriptive words |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Troponin I levels | One day after study drug administration | Troponin I levels on blood work |
| ECG: ST segment | 5 minutes after study drug administration | Changes to the ST segment on ECG |
Other
| Measure | Time frame | Description |
|---|---|---|
| Estimated blood loss during surgery | Within 1 hour of study drug administration | Recorded from anesthesiologists assessment |
| Surgeons assessment of uterine tone | 3 minutes after study drug administration | Assessed as a binary of adequate or not adequate |
| Hemoglobin change | Preoperatively and one day postoperatively | Assessed as a difference between preoperative and postoperative hemoglobin |
Countries
Canada
Contacts
Primary ContactJordan Leitch, MD
Backup ContactTaylor Perry, MD
Outcome results
None listed