Evaluation of the Impact of Carbetocin Administration (Bolus Versus Infusion) on Heart Rate and Other Hemodynamic Parameters.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Delta Heart Rate
研究概览
简要总结
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.
详细描述
The purpose of this prospective pragmatic study is to determine if an infusion of carbetocin over 10 minutes will reduce hemodynamic compromise in comparison to a rapid intravenous bolus (less than 2 seconds) during elective cesarean delivery under spinal anesthesia.
In this prospective, randomized and controlled study, each parturient will enter the operating room on the day scheduled for there surgery. All the classic monitors will be installed, along with the Edwards (Clear sight system).
Each patient will receive an antacid prophylaxis of 30 ml of sodium citrate per mouth 30 min before surgery. Baseline measures of BP (blood pressure), HR (Heart Rate), O2 Arterial Saturation will be taken before entering in the operating room, in a calm environment.
The anesthetic technique will be standardized. Spinal anesthesia will be performed in the sitting position by the anesthesiologist in charge of the patient, with the local anesthetic injected between L2 to L5 spinal level. The anesthetic solution will consist of hyperbaric bupivacaine 0.75% 10.5 mg, fentanyl 15 μg, and morphine 150 μg with a Whitacre needle 25G ou 27G. Then, the patient will be immediately placed in the supine position, with a cushion under their right hip or a left lateral tilt. Antibiotic prophylaxis will be administered to each patient before incision.
Each patient included in the study will have a phenylephrine infusion of 0.5 mcg/kg/min (lean body weight) started immediately after the injection of local anesthetic. A bolus of phenylephrine 1.5 mcg/kg (lean body weight) will be administered in case of a hypotensive episode. A hypotensive episode will be defined as 2 consecutive Systolic BP (SBP) measurements less than 20% below the baseline value. The treatment of hypotension consists of Phenylephrine 1.5 mcg/kg intravenous bolus will be administered if HR > 55 bpm or Ephedrine 5 mg intravenous bolus if HR is < 55 bpm. If only the HR is < 55 bpm, but SBP is normal, Glycopyrrolate 0.2 mg intravenous bolus will be administered and the patient will be excluded. In the case of a hypertensive episode, where systolic BP is > 120% Baseline value, treatment will consist of a decrease in the phenylephrine infusion rate by 0.2 mcg/kg/min.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Only the clinical nurse won't be blinded
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- 未提供
研究组 & 干预措施
Carbetocin bolus
Patients in this arm will receive both syringes : the 3 ml and the 10 ml. The carbetocin 100 mcg will be in the 3 ml syringe over 2 sec and the 10 ml syringe will contain only normal saline given as infusion over 10 min.
干预措施: Carbetocin bolus (Drug)
Carbetocin infusion
Patients in this arm will receive both syringes : the 3 ml and the 10 ml. The carbetocin 100 mcg will be in the 10 ml syringe as an infusion over 10min and the 3 ml syringe will contain only normal saline given iv over 2 sec as a bolus.
干预措施: Carbetocin infusion (Drug)
结局指标
主要结局
Delta Heart Rate
时间窗: From the administration of the drug study every 20 secondes until 20 minutes after the drug injection for each patient.
To compare the variation of HR (delta heart rate) after the administration of Carbetocin when administered in Infusion vs Bolus, in patients with elective Caesarian under regional anesthesia.
次要结局
- Delta Stroke Volume(From the administration of the drug study every 20 secondes until 20 minutes after the drug injection for each patient.)
- Delta Systemic Vascular Resistance(From the administration of the drug study every 20 secondes until 20 minutes after the drug injection for each patient.)
- Phenylephrine consomption in the Infusion group VS Bolus group(From the administration of the drug study every 5 minutes until 20 minutes after the drug injection for each patient.)
- Area Under the Curve of Cardiac Output for Carbetocin Infusion Vs Bolus(From the administration of the drug study until 20 minutes after the drug injection for each patient.)
- Incidence of headache(From the administration of the drug study until 20 minutes after the drug injection for each patient.)
- Incidence of tremulousness(From the administration of the drug study until 20 minutes after the drug injection for each patient.)
- Delta Stroke Volume Variation(From the administration of the drug study every 20 secondes until 20 minutes after the drug injection for each patient.)
- Peak value of Cardiac Output(From the administration of the drug study every 20 secondes until 20 minutes after the drug injection for each patient.)
- Peak value of Systemic Vascular Resistance(From the administration of the drug study every 20 secondes until 20 minutes after the drug injection for each patient.)
- Incidence of nausea/vomiting(From the administration of the drug study until 20 minutes after the drug injection for each patient.)
- Delta Cardiac Output(From the administration of the drug study every 20 secondes until 20 minutes after the drug injection for each patient.)
- Area Under the Curve of Phenylephrine consomption for Carbetocin Infusion Vs Bolus(From the administration of the drug study until 20 minutes after the drug injection for each patient.)
- Time (bloc of 5 minutes) for the maximal consomption of phenylephrine(From the administration of the drug study every 5 minutes until 20 minutes after the drug injection for each patient.)
- Amount of time (in minutes) Heart Rate will be at his peak after administration of carbetocin(From the administration of the drug study every 20 secondes until 20 minutes after the drug injection for each patient.)
- Incidence of thoracic pain(From the administration of the drug study until 20 minutes after the drug injection for each patient.)
- Peak value of Heart Rate(From the administration of the drug study every 20 secondes until 20 minutes after the drug injection for each patient.)
- Peak value of Stroke Volume(From the administration of the drug study every 20 secondes until 20 minutes after the drug injection for each patient.)
- Area Under the Curve of Heart Rate for Carbetocin Infusion vs Bolus(From the administration of the drug study until 20 minutes after the drug injection for each patient.)
- Incidence of flushing(From the administration of the drug study until 20 minutes after the drug injection for each patient.)
- Incidence of abdominal pain(From the administration of the drug study until 20 minutes after the drug injection for each patient.)
- Incidence of dyspnea(From the administration of the drug study until 20 minutes after the drug injection for each patient.)
研究者
Philippe Richebe
Professor of Anesthesiology and Pain Medicine
Ciusss de L'Est de l'Île de Montréal