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临床试验/NCT04629573
NCT04629573已完成不适用

Epidural Anesthesia and Myomectomy-Associated Blood Loss: A Prospective Randomised Controlled Study

Assiut University1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2014年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
78
试验地点
1
主要终点
Blood loss

研究概览

简要总结

This is a prospective study for abdominal myomectomies performed from June 2012 to June 2019 by a single surgeon in a tertiary care referral hospital. Large uterine myoma was defined as the estimated diameter of dominant myoma equal to or larger than 10 cm by sonography. Demographics, diagnosis, perioperative variables, operative outcomes and complications were recorded. The Intraoperative anesthetic management, blood and blood products transfusion, and total volume of blood loss, as well as postoperative follow-up, were reviewed for each patient.

详细描述

Randomization and Blinding: To allow randomization, researchers prepared the management protocol for each group and sealed one protocol per envelope with a computer-generated number assigned prior to study initiation. Randomization was performed by picking the numbered study envelopes sequentially and opened before induction of anesthesia by the anesthesia doctor and managing the participant based on the enclosed protocol. The study will not be double-blinded, as it is impossible to blind the health care workers and women involved for the strategy to which the woman is allocated.

Interventions Anesthesia technique: On arrival to the operative theatre, an 18 gauge IV catheter was inserted and 500 ml of NaCl (0.9%) was infused, 1 mg midazolam was administered iv as premedication. Patients were monitored with continuous electrocardiography and pulse oximetry and intermittent non-invasive blood pressure measurements every 5 min.

Lumbar epidural: Epidural procedure was performed by attending anesthesiologists who had completed at least 50 epidural procedures during their training. Patient was placed in the sitting position, the skin over the lumbar area was cleaned and a sterile technique was observed throughout the procedure. Skin and subcutaneous tissue were infiltrated with 1% lidocaine 2 mL at the intended site of epidural placement (L2-3 or L3-4 interspace). The lumbar epidural space was then located, using a midline approach with an 18 gauge Tuohy epidural needle via a loss of resistance technique with 2 mL of saline, 20 gauge epidural catheter was placed in each patient. We deliver an initial bolus of 20 ml bupivacaine 0.5% plus 100 mcg Fentanyl, followed by continuous infusion of bupivacaine 0.5% plus 1mcg/ml Fentanyl (3-5 ml/hr.).

General anesthesia: Anesthesia was initiated with IV fentanyl 1 µg/kg, propofol 2 mg/kg and cisatracurium 0.15 mg/kg to facilitate endotracheal intubation. After tracheal intubation, anesthesia was maintained with sevoflurane in O2 and air (FiO2 of 0.5), cisatracurium 1µg/kg/min and fentanyl 0.5 µg/ kg /h were infused. Volume-Controlled ventilation was performed in all patients. Cisatracurium and fentanyl infusion was stopped at the end of surgery, neuromuscular blockade was reversed, and the patient was extubated and send to post-anesthesia care unit.

Myomectomy: Abdominal myomectomy was performed in the standard conventional fashion. A single surgeon handled all the surgical procedures. The myomectomy was performed by enucleating the fibroid and closing the uterine defect in multiple layers. The use of energy devices, suture type, and adhesion barriers were at the discretion of the surgeon.

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
None

入排标准

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

入选标准

  • 未提供

排除标准

  • Patients with previous uterine surgery (myomectomy, cesarean delivery)
  • Coagulopathy or other bleeding diathesis
  • Severe anemia (Hb under 5.0 g/dl)

结局指标

主要结局

Blood loss

时间窗: 24 hours

Intraoperative blood loss

次要结局

未报告次要终点

研究者

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

Abdelrady S Ibrahim, MD

Professor of Anesthesia

Assiut University

研究点 (1)

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