Maintenance Infusion of Oxytocin Following Elective Cesarean Deliveries: an Up-down Sequential Allocation Dose-response Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Uterine tone upon discharge from the post anesthetic care unit (PACU): questionnaire
研究概览
简要总结
This study is designed to determine the minimal effective oxytocin maintenance dose required during cesarean delivery to achieve the best effect. Oxytocin is a drug which is routinely used to help contract the uterus and keep it contracted after the delivery of the baby and placenta. The aim of oxytocin is to reduce the amount of blood that might be lost. In order to determine the minimal effective dose, the investigators will conduct a dose-finding study. The first patient will receive a set oxytocin infusion. If the uterus contracts well, this is considered satisfactory and the next patient will receive the same dose. If the uterus does not contract well, this is considered unsatisfactory and the next patient will receive a higher dose. The dose for the next patient will be determined based on the results of the uterine contraction of the previous patient.
The investigators hypothesize that the ED90 of an oxytocin infusion rate to maintain a satisfactory uterine tone during a cesarean delivery in non-laboring women, would be lower than that found in previous studies without an initial bolus (less than 16 IU/h).
详细描述
This study will be conducted as a prospective, double blinded clinical trial (patient, anesthesiologist and obstetrician blinded to the oxytocin dose), in an up-down sequential allocation fashion. The objective of the study is to determine the minimum effective dose of oxytocin infusion required to produce appropriate uterine contraction during and after cesarean delivery under neuraxial anesthesia in non-laboring women. For the purpose of this study, the minimum effective dose is defined to be that at which adequate response occurs in 90% of patients, i.e. ED90.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Elective uncomplicated cesarean delivery under neuraxial anesthesia
- •>18 year-old with ASA status II or III, with a singleton gestation and a gestational age between 37 to 42 weeks Informed consent to participate in this study
排除标准
- •Refusal to give written informed consent
- •Allergy or hypersensitivity to oxytocin
- •Body mass index ≥ 40 kg/m2on the day of admission
- •A history of hypertension and/ or severe cardiac disease(s)
- •Contra-indications for neuraxial anesthesia
- •Conditions that predispose to uterine atony and postpartum hemorrhage such as placenta previa, multiple gestation, preeclampsia, macrosomia (≥ 4 kg), polyhydramnios, uterine fibroids in and near operating field, previous history of uterine atony and postpartum bleeding, or bleeding diathesis.
研究组 & 干预措施
Oxytocin infusion rate 2 IU/h
The maintenance infusion rate of oxytocin will be 2 IU/h.
干预措施: Oxytocin (Drug)
Oxytocin infusion rate 4 IU/h
The maintenance infusion rate of oxytocin will be 4 IU/h.
干预措施: Oxytocin (Drug)
Oxytocin infusion rate 6 IU/h
The maintenance infusion rate of oxytocin will be 6 IU/h.
干预措施: Oxytocin (Drug)
Oxytocin infusion rate 8 IU/h
The maintenance infusion rate of oxytocin will be 8 IU/h.
干预措施: Oxytocin (Drug)
Oxytocin infusion rate 10 IU/h
The maintenance infusion rate of oxytocin will be 10 IU/h.
干预措施: Oxytocin (Drug)
Oxytocin infusion rate 12 IU/h
The maintenance infusion rate of oxytocin will be 12 IU/h.
干预措施: Oxytocin (Drug)
Oxytocin infusion rate 14 IU/h
The maintenance infusion rate of oxytocin will be 14 IU/h.
干预措施: Oxytocin (Drug)
Oxytocin infusion rate 16 IU/h
The maintenance infusion rate of oxytocin will be 16 IU/h.
干预措施: Oxytocin (Drug)
结局指标
主要结局
Uterine tone upon discharge from the post anesthetic care unit (PACU): questionnaire
时间窗: 2 hours
Uterine tone will be evaluated as satisfactory or unsatisfactory by the obstetrician throughout the surgery, starting at 5 minutes after the oxytocin infusion. It will also be measured at 10 minutes following the oxytocin infusion and every 10 minutes following that for the duration of the surgery. Unsatisfactory uterine tone at any time until discharge from the PACU will be considered a failure of the maintenance infusion.
次要结局
- Presence of vomiting: questionnaire(2 hours)
- Incidence of post partum hemorrhage(24 hours)
- Postoperative uterine position in the PACU(3 hours)
- Tachycardia: heart rate greater than 130% of baseline(2 hours)
- Intraoperative requirement for additional uterotonic medication(2 hours)
- Requirement for additional uterotonic medication in the PACU(2 hours)
- Episodes of bleeding postpartum(24 hours)
- Requirement for additional uterotonic medication from discharge from the PACU until 24 hours postpartum.(24 hours)
- Hypotension: systolic blood pressure less than 80% of baseline(2 hours)
- Hypertension: systolic blood pressure greater than 120% of baseline(2 hours)
- Bradycardia: heart rate less than 70% of baseline(2 hours)
- Presence of atrial flutter: ECG(2 hours)
- Presence of nausea: questionnaire(2 hours)
- Presence of chest pain: questionnaire(2 hours)
- Calculated blood loss(24 hours)
- Need for blood transfusion(24 hours)
- Presence of ventricular tachycardia: ECG(2 hours)
- Presence of atrial fibrillation: ECG(2 hours)
- Presence of shortness of breath: questionnaire(2 hours)
- Presence of headache: questionnaire(2 hours)