Cardiac Arrythmias
Conditions
Keywords
Carbetocin, Myocardial repolarization
Brief summary
Relationship between carbetocin dose on transmural dispersion of repolarization (TDR).
Detailed 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
Interventions
DRUGCarbetocin
50 mcg or 100 mcg bolus of carbetocin
Sponsors
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tp-e | 5 minutes post-carbetocin administration | Time interval between peak and end of T-wave (Tp-e) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| QTc at 5 Min | 5 min post-carbetocin administration | Bazette corrected Q-T interval |
| QTc 10 Min | 10 minutes post-carbetocin administration | Bazette corrected Q-T interval (QTc) |
| Arrhythmia | perioperatively, typically ranging 30 minutes-1 hour | Occurrence of Atrial or Ventricular Arrhythmias |
| Tp-e 5 Min Post-spinal | 5 minutes after administration of spinal anesthesia | Time between peak and end of T-wave, |
| Tp-e at 10 Min | 10 minutes post-carbetocin administration | Time between peak and end of T-wave |
| QTc 5 Min Spinal | 5 min post-administration of spinal anesthesia | Bazette corrected Q-T interval change after spinal anesthesia |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Participant Receives 50 mcg of Carbetocin Post-delivery. Participant receives 50 mcg of carbetocin post-delivery.
Carbetocin: 50 mcg or 100 mcg bolus of carbetocin | 22 |
| Participant Receives 100 mcg of Carbetocin Post-delivery. Participant receives 100 mcg of carbetocin post-delivery.
Carbetocin: 50 mcg or 100 mcg bolus of carbetocin | 19 |
| Total | 41 |
Baseline characteristics
| Characteristic | Participant Receives 50 mcg of Carbetocin Post-delivery. | Participant Receives 100 mcg of Carbetocin Post-delivery. | Total |
|---|---|---|---|
| Age, Continuous | 34.5 years STANDARD_DEVIATION 4.3 | 35.7 years STANDARD_DEVIATION 2.8 | 35 years STANDARD_DEVIATION 3.7 |
| Baseline QTc | 413.7 milliseconds STANDARD_DEVIATION 11 | 409.0 milliseconds STANDARD_DEVIATION 15.8 | 411.6 milliseconds STANDARD_DEVIATION 13.5 |
| Baseline Tp-e | 67.5 milliseconds STANDARD_DEVIATION 8.2 | 69.6 milliseconds STANDARD_DEVIATION 5.7 | 68.5 milliseconds STANDARD_DEVIATION 7.1 |
| Gestational Age | 38.9 weeks STANDARD_DEVIATION 0.8 | 39.2 weeks STANDARD_DEVIATION 0.5 | 39.0 weeks STANDARD_DEVIATION 0.7 |
| Gravida | 2 pregnancies | 2 pregnancies | 2 pregnancies |
| Heart Rate | 83.0 bpm STANDARD_DEVIATION 8.6 | 81.8 bpm STANDARD_DEVIATION 9 | 82.0 bpm STANDARD_DEVIATION 8.7 |
| Mean Arterial Pressure | 89.7 mmHg STANDARD_DEVIATION 10.4 | 88.5 mmHg STANDARD_DEVIATION 8.3 | 89.2 mmHg STANDARD_DEVIATION 9.4 |
| Parity greater than 0 | 15 participants | 14 participants | 29 participants |
| Parity of 0 | 7 participants | 5 participants | 12 participants |
| Phenylephrine Dose | 1459.0 micrograms STANDARD_DEVIATION 426.1 | 1538.1 micrograms STANDARD_DEVIATION 479.2 | 1495.6 micrograms STANDARD_DEVIATION 500.2 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Canada | 22 participants | 19 participants | 41 participants |
| Sex: Female, Male Female | 22 Participants | 19 Participants | 41 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Weight | 74.9 Kilograms STANDARD_DEVIATION 13.2 | 75.1 Kilograms STANDARD_DEVIATION 10.7 | 75.0 Kilograms STANDARD_DEVIATION 12 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Tp-e
Time interval between peak and end of T-wave (Tp-e)
Time frame: 5 minutes post-carbetocin administration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participant Receives 50 mcg of Carbetocin Post-delivery. | Tp-e | 69.5 milliseconds | Standard Deviation 7.7 |
| Participant Receives 100 mcg of Carbetocin Post-delivery. | Tp-e | 74.7 milliseconds | Standard Deviation 4.7 |
Secondary
Arrhythmia
Occurrence of Atrial or Ventricular Arrhythmias
Time frame: perioperatively, typically ranging 30 minutes-1 hour
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participant Receives 50 mcg of Carbetocin Post-delivery. | Arrhythmia | 0 Participants |
| Participant Receives 100 mcg of Carbetocin Post-delivery. | Arrhythmia | 0 Participants |
Secondary
QTc 10 Min
Bazette corrected Q-T interval (QTc)
Time frame: 10 minutes post-carbetocin administration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participant Receives 50 mcg of Carbetocin Post-delivery. | QTc 10 Min | 431.6 milliseconds | Standard Deviation 18.2 |
| Participant Receives 100 mcg of Carbetocin Post-delivery. | QTc 10 Min | 431.9 milliseconds | Standard Deviation 15.4 |
Secondary
QTc 5 Min Spinal
Bazette corrected Q-T interval change after spinal anesthesia
Time frame: 5 min post-administration of spinal anesthesia
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participant Receives 50 mcg of Carbetocin Post-delivery. | QTc 5 Min Spinal | 409.4 milliseconds | Standard Deviation 19.2 |
| Participant Receives 100 mcg of Carbetocin Post-delivery. | QTc 5 Min Spinal | 413.6 milliseconds | Standard Deviation 17.4 |
Secondary
QTc at 5 Min
Bazette corrected Q-T interval
Time frame: 5 min post-carbetocin administration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participant Receives 50 mcg of Carbetocin Post-delivery. | QTc at 5 Min | 435.1 milliseconds | Standard Deviation 18.3 |
| Participant Receives 100 mcg of Carbetocin Post-delivery. | QTc at 5 Min | 434.2 milliseconds | Standard Deviation 18.8 |
Secondary
Tp-e 5 Min Post-spinal
Time between peak and end of T-wave,
Time frame: 5 minutes after administration of spinal anesthesia
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participant Receives 50 mcg of Carbetocin Post-delivery. | Tp-e 5 Min Post-spinal | 69.5 milliseconds | Standard Deviation 8.6 |
| Participant Receives 100 mcg of Carbetocin Post-delivery. | Tp-e 5 Min Post-spinal | 70.9 milliseconds | Standard Deviation 6.5 |
Secondary
Tp-e at 10 Min
Time between peak and end of T-wave
Time frame: 10 minutes post-carbetocin administration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participant Receives 50 mcg of Carbetocin Post-delivery. | Tp-e at 10 Min | 69.4 milliseconds | Standard Deviation 8.2 |
| Participant Receives 100 mcg of Carbetocin Post-delivery. | Tp-e at 10 Min | 71.8 milliseconds | Standard Deviation 5.5 |