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临床试验/NCT04609410
NCT04609410终止不适用

Bleeding in Moderate Versus Deep Neuro Muscular Blockade for Laparoscopic Liver Surgery

Università Vita-Salute San Raffaele2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2020年10月30日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
48
试验地点
2
主要终点
Total intra-operative blood loss

研究概览

简要总结

Blood loss during liver resection surgery affects patients morbidity, short and long-term mortality. Among non-surgical interventions to minimize intraoperative blood loss and perioperative blood products transfusion, maintaining conditions of low central venous pressure is considered as standard of care. In animals undergoing laparoscopic hepatectomy, reducing airway pressures represents a minimally invasive measure to reduce central venous pressure and therefore bleeding from the hepatic vein. Neuromuscular blocking agents are usually administered during anesthesia to facilitate endotracheal intubation and to improve surgical conditions: a deep level of neuromuscular blockade has already been shown to reduce peak airway pressures and plateau airway pressures in non-abdominal procedures. Such airway pressures reduction can potentially limit bleeding from hepatic veins during transection phase in liver surgery. The aim of the present study is to evaluate the impact of deep neuromuscular blockade on bleeding (as a consequence of reduced airway peak pressure and plateau pressure) in hepatic laparoscopic resections. Patients undergoing laparoscopic liver resection will be randomized to achieve, using intravenous Rocuronium, either a deep neuromuscular blockade (post-tetanic count = 0 and/or = 1 and train of four count = 0) or moderate neuromuscular blockade (train of four count ≥ 1 and/or post-tetanic count > 5) during surgery. Neuromuscular blockade measurements will be performed every 15 minutes. The primary endpoint is to assess the total blood loss at the end of the resection phase.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • Patients undergoing laparoscopic liver resection
  • Patients ≥ 18 years old
  • Patients willing to participate to the study and able to validly sign informed consent.

排除标准

  • Patients presenting a pre-operative platelet count < 50 x 109/L and/or patients with active pre-operative bleeding
  • Patients with planned requirement of continuous neuromuscular blockade monitoring (upon clinical judgement)
  • Known hypersensitivity / previous allergic reactions to study medications
  • Planned total intra-venous anesthesia technique
  • Pregnant or breastfeeding patients.

结局指标

主要结局

Total intra-operative blood loss

时间窗: Postoperative day 0

total blood loss at the end of surgery, measured in milliliters (ml) of blood inside the aspirator canister

次要结局

  • Airway peak and plateau pressures(Postoperative day 0)
  • Number of blood product units transfused(Up to hospital discharge, an average of 5 days)
  • Surgery and hepatic resection time(Postoperative day 0)
  • Incidence of surgical revision(Up to hospital discharge, an average of 5 days)
  • Quality of surgical field(Postoperative day 0)

研究者

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

Giovanni Landoni

MD, Associate Professor

Università Vita-Salute San Raffaele

研究点 (2)

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