Impact of Carbetocin Administration on Heart Rate When Given as an Infusion Versus as a Bolus.

• Status: Completed
• Trial end date: 2021-01-15
• Target enrollment: 0
• Participant gender: Female

Summary

Prospective, randomized and controlled study who will be conducted at Maisonneuve-Rosemont hospital with the following objectives:

To determine if an infusion of carbetocin over 10 minutes will reduce hemodynamic side effects, especially the peak of heart rate, in comparison to a rapid intravenous bolus (less than 2 seconds).

To determine if an infusion of carbetocin will reduce the other side effects of duratocin in comparison to a rapid intravenous bolus.

Study plans to enroll 70 adult patients scheduled to undergo elective cesarean delivery under spinal anesthesia.

Half of the patient will receive Carbetocin 100 mcg intravenous as a bolus (less than 2 seconds) and the other half will receive Carbetocin 100 mcg intravenous infusion over 10 minutes.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ciusss de L'Est de l'Île de Montréal
• Treatments: Carbetocin; Oxytocin

Criteria

Inclusion Criteria:

• Elective caesarean delivery

• 37 weeks or more of gestation

• ASA status I or II

• Patients > 18 years old

• Spinal anesthesia

Non-Inclusion Criteria:

• Multiple gestation

• Morbid obesity (BMI > 40 at first prenatal medical visit)

• Coagulopathy

• Active labour

• Polyhydramnios

• Leiomyoma/Uterine fibroma

• Hypotensive illness/Pre-eclampsia/Eclampsia

• Placenta accreta/Previa

• Cardiopathy of any kind

• Patient on medication affecting hemodynamics (ex. B-blocker, CCG, antihypertensive, etc)

• Emergent cesarean delivery

• Contra-indications to spinal anesthesia

• General anesthesia for cesarean delivery

• Known allergy to carbetocin

• Patient refusal

Exclusion criteria

• Patient who receives iv ephedrine or glycopyrrolate during the study period

• Administration of a second dose of carbetocin or other uterotonic agent.

• Onset of post-partum hemorrhage defined as blood loss > 1000 ml or uncontrolled bleeding after delivery of the baby.

• Patient who needs an exteriorization of the uterus for repair following caesarean delivery.