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临床试验/NCT00777166
NCT00777166已完成4 期

Phase 4 Study of Oxytocin Used During Cesarean Section

Uppsala University1 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2005年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
103
试验地点
1
主要终点
ST segment depression on ECG

研究概览

简要总结

Oxytocin has cardio vascular effects as hypotension, tachycardia and possibly coronary spasm. The uterotonic effect of the drug is used during cesarean section, to minimize blood loss.ECG changes suggestive of cardiac ischemia (ST depression) has been showed in previous studies of patients undergoing cesarean section i regional anaesthesia. The effect of oxytocin on this outcome has not been investigated to any extent.

In the current study, we tested the hypothesis that there was no difference in occurrence of ECG changes (ST segment depression) between two doses of oxytocin. Participants were randomized to receive either 5 or 10 units of oxytocin in a double blinded fashion.

Main outcome measure is occurrence of significant ST depression on ECG. Secondary outcome measures are mean arterial pressure, heart rate, blood loss, symptoms as chest pain, shortness of breath and feeling of heaviness on the chest.

详细描述

All healthy term participants scheduled to undergo elective caesarean section under spinal anaesthesia at the Department of Obstetrics and Gynecology, University Hospital, Uppsala Sweden and who were > 18 years old, were candidates for inclusion in the study. .

The study was approved by the regional ethics committee and informed written consent was obtained from each participant.

ECGs were recorded by continuous ambulatory ECG (Holter) monitoring (GE Medical systems SEER/MARS, UK) during the peroperative period utilizing leads V3, V5 and avF. As secondary outcomes, symptoms as chest pain, shortness of breath and feeling of heaviness on the chest and, Troponin I levels 12 hours postoperatively, were recorded. Also, as secondary outcomes, differences in blood pressure, heart rate, and blood loss were measured.

Before induction of anaesthesia, patients received 1000 mL of lactated Ringer's solution intravenously. Thereafter an additional 500-1000 mL of lactated Ringer's solution or 500 mL Hydroxyethyl starch was infused if considered needed by the anaesthesiologist.

Spinal anaesthesia was established in the sitting position at lumbal interspace L2/L3 or L3/L4. Non invasive blood pressure (systolic, diastolic and mean arterial pressure, MAP) and heart rate was monitored every 2 minutes, throughout surgery. Oxytocin was given as an intravenous bolus dose immediately after clamping of the umbilical cord. Blood loss during the operation was estimated and recorded. During surgery, any spontaneous complaints by the patients of symptoms as chest pain, shortness of breath and feeling of heaviness on the chest, was recorded as well as duration of symptoms. Episodes of chest pain were assessed with the visual analogue scale (VAS).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Healthy women >/= 18 years scheduled to planned cesarean section

排除标准

  • BMI > 35
  • Multiple birth
  • Complications to pregnancy
  • Non proficiency in the Swedish language

研究组 & 干预措施

1

Active Comparator

oxytocin 5 units

干预措施: oxytocin (Drug)

2

Active Comparator

oxytocin, 10 units

干预措施: oxytocin (Drug)

结局指标

主要结局

ST segment depression on ECG

时间窗: 30 minutes

次要结局

  • mean arterial blood pressure, heart rate, blood loss and symptoms as chest pain(60 minutes)

研究者

发起方
Uppsala University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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