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Completed

NCT Number: NCT03716076

Carbetocin on Myocardial Repolarization Dynamics in Obstetrics Study

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

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Key information

Conditions

Cardiac Arrythmias

Age range

19 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

BC Women's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Carbetocin

Drug

50 mcg or 100 mcg bolus of carbetocin

Primary outcomes

  1. Tp-e

    Time frame: 5 minutes post-carbetocin administration

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

Secondary outcomes

  1. Arrhythmia

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

    Occurrence of Atrial or Ventricular Arrhythmias

  2. QTc at 5 Min

    Time frame: 5 min post-carbetocin administration

    Bazette corrected Q-T interval

  3. QTc 10 Min

    Time frame: 10 minutes post-carbetocin administration

    Bazette corrected Q-T interval (QTc)

  4. QTc 5 Min Spinal

    Time frame: 5 min post-administration of spinal anesthesia

    Bazette corrected Q-T interval change after spinal anesthesia

  5. Tp-e 5 Min Post-spinal

    Time frame: 5 minutes after administration of spinal anesthesia

    Time between peak and end of T-wave,

  6. Tp-e at 10 Min

    Time frame: 10 minutes post-carbetocin administration

    Time between peak and end of T-wave

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

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

Acronym: CaRDIO

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Oct 23, 2018
Registry last updated
May 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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