跳至主要内容
临床试验/NCT01466530
NCT01466530已完成2 期

Effects of Preoperative Sublingual Misoprostol on Uterine Tone During Isoflurane Anaesthesia for Caesarean Section

Mansoura University1 个研究点 分布在 1 个国家目标入组 366 人开始时间: 2006年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
366
试验地点
1
主要终点
estimated blood loss after caesarean delivery

研究概览

简要总结

Misoprostol would reduce the uterine bleeding after caesarean delivery, without harmful effects on either mother or baby. The investigators postulated that the use of sublingual misoprostol during isoflurane anaesthesia for uncomplicated caesarean delivery would reduce maternal haemorrhage, uterine atonic effects, and the need for additional uterotonic agents, without harmful effects on either mother or baby. Therefore, the present study was designed to evaluate the effects of preoperative sublingual misoprostol on maternal blood loss, uterine tone, the need for additional oxytocin and neonatal outcome after elective caesarean delivery under isoflurane anaesthesia.

详细描述

Volatile anaesthetics including sevoflurane, desflurane, and isoflurane are often used during general anaesthesia for caesarean delivery. The cost effectiveness of isoflurane anaesthesia1 for caesarean delivery is widely used at many centres including the authors' centre, where general anaesthesia is commonly used for caesarean deliveries than did regional anaesthesia because of the refusal of many ladies for the later, especially in the light of evidence-based equivocal maternal or neonatal outcomes of both techniques. 2 However, isoflurane in similar to other inhalational anaesthetics have been shown a dose-dependent (from 0.5 to 2.35 minimum alveolar concentration (MAC)) induced myometrial relaxation in 25% of parturients with added risks of postpartum haemorrhage, 3-5 which may be mediated through the inhibition of the oxytocin-induced contraction,6 decrease in intracellular concentration of free calcium,7 inhibition of voltage-dependent calcium channels activity,8 and activation of adenosine triphosphate-sensitive potassium channels (K (ATP))9 of pregnant uterine smooth muscle.

Several uterotonics such as oxytocin reduce postpartum haemorrhage by inducing uterine contraction, but with added risks of haemodynamic adverse effects. 10 Sublingual or rectal misoprostol, a prostaglandin E1 analogue, in doses of 100 to 800 µg is safe and as effective as intravenous infusion of oxytocin in reducing blood loss and the need for additional oxytocin after caesarean delivery under either spinal or general anaesthesia, with occurrence of transient side effects such as nausea, shivering and pyrexia. 11-17 Misoprostol possess several advantages over oxytocin, including long shelf life, stability at room temperature, and possible buccal, rectal and sublingual administration. 11, 16The later has many advantages such as rapid uptake, long-lasting duration of effect, and greatest bioavailability, compared with other routes of misoprostol administration. 18 Up to our best knowledge, this trial was the first one studied the inhibitory effects of misoprostol on the uterine atonic effects of inhalational anaesthetics.

Based upon previous published data, 19 blood loss after caesarean delivery was normally distributed with standard deviation 560 ml. A priori power analysis indicated that 174 patients in each group would be sufficient to detect a 20% reduction in blood loss after caesarean delivery, with a type-I error of 0.05 and a power of 90%. The investigators added 10% more patients to account for patients dropping out during the study.

Patients were randomly allocated to receive sublingual 400 µg of misoprostol or identical placebo two tablets after tracheal intubation before surgery.

Anaesthetic management was standardized in all studied patients. Oral ranitidine 150 mg was given the night before and on the morning of surgery, with 0.3 mol/L sodium citrate (30 mL) given 15 min before induction. In the operating theatre women were positioned supine on the operating table with 15° firm rubber wedge under the right hip to effect left uterine displacement. A slow 500-mL i.v. infusion of lactated Ringer's solution was given to all subjects over 20 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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • American Society of Anesthesiologists class I and II
  • parturients aged 18-35 years
  • uncomplicated singleton pregnancies
  • Gestational age >= 36 weeks
  • elective caesarean delivery
  • refused regional anaesthesia
  • requested general anaesthesia.

排除标准

  • allergy to prostaglandins
  • bronchial asthma
  • bleeding disorders
  • cardiac diseases
  • inflammatory bowel diseases
  • multiple pregnancies
  • preeclampsia
  • placenta praevia
  • abruptio placenta
  • previous postpartum haemorrhage
  • antepartum haemorrhage
  • grand multiparity
  • uterine fibroids
  • intrauterine growth restriction
  • fetal abnormality

研究组 & 干预措施

Placebo

Placebo Comparator

sublingual two moistened white coated placebo tablets

干预措施: Placebo (Drug)

Misoprostol

Active Comparator

sublingual misoprostol (400 µg)

干预措施: Misoprostol (Drug)

结局指标

主要结局

estimated blood loss after caesarean delivery

时间窗: up to 24 hours

estimated blood loss (EBL) = pregnancy blood volume (ml) (EBV) x \[preoperative haematocrit - postoperative haematocrit\] / preoperative haematocrit, where EBV measured as shown in the following formula; (0.75 x {\[maternal height (inches) x 50\] + \[maternal weight in pounds x 25\]})

次要结局

  • uterine tone(5 min, 10 min, 15 min, 20 min, 25 min, 30 min)
  • need for additional oxytocin(8 hrs)
  • haematocrit levels(24 hours, 48 hours)
  • neonatal outcome(1 min and 5 min)
  • adverse effects(48 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed R El Tahan

Associate Professor

Mansoura University

研究点 (1)

Loading locations...

相似试验