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

NCT03404544 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2021-10-04

No results posted yet for this study

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.

Conditions

  • Cesarean Section Complications
  • Hemodynamic Instability

Interventions

DRUG

Carbetocin bolus

Carbetocin 100 mcg intravenous as a bolus (less than 2 sec)

DRUG

Carbetocin infusion

Carbetocin 100 mcg intravenous as a 10 minutes infusion

Sponsors & Collaborators

  • Ciusss de L'Est de l'Île de Montréal

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-11
Primary Completion
2020-01-28
Completion
2021-01-15

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03404544 on ClinicalTrials.gov