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临床试验/NCT05294926
NCT05294926Unknown早期 1 期

Comparison Of Deep Versus Moderate Neuromuscular Blockade on Intra-Operative Blood Loss During Spinal Surgery, Randomized Double Blinded Clinical Trial

Assiut University0 个研究点目标入组 88 人开始时间: 2022年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
入组人数
88
主要终点
Volume of surgical bleeding.

研究概览

简要总结

Reduction of intra-operative blood loss

详细描述

Spine surgery is usually performed using a posterior approach with the patient in the prone position, but on the other hand this position causes venous engorgement in the back and increases bleeding with the risk of interruption of surgery and increases the need for blood transfusion. The prone position also produces undesirable haemodynamic changes resulting from compression of large vessels and decreased venous return to the heart.

Deep neuromuscular blockade has been shown to improve surgical conditions compared with moderate neuromuscular blockade in various surgical procedures specially different laparoscopic procedures to optimize surgical field conditions. In spine surgery, although many other factors such as the body habitus of the patient and the surgical equipment are important, an improvement in surgical field conditions can be achieved through reducing muscle tension in the back, and also reducing intra-abdominal and thoracic pressure. This goal may be attainable by using deep neuromuscular blockade. Better operating conditions offer the surgeon easier access to the surgical field with less damage. However, the effect of deep neuromuscular blockade on surgical bleeding in spinal surgery in the prone position has been yet under evaluation.

The investigators hypothesise that deep, compared with moderate, neuromuscular blockade would cause less surgical bleeding in spinal surgery in the prone position. The investigators aim to evaluate the effects and superiority of deep neuromuscular blockade on surgical bleeding in patients undergoing posterior lumbar interbody fusion surgery in the prone position.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18- 65 years.
  • American Society of Anesthesiologists physical status classification (ASA) I - III
  • Patients scheduled for posterior lumbar interbody fusion (2-level or 3-level).

排除标准

  • Urgent or emergency case or re-operation.
  • History of pre-operative anticoagulant medication or an indication for peri-operative anticoagulant medication.
  • ASA classification more than III.
  • Age less than 16 years.
  • Reduced left and right ventricular function (ejection fraction <40%).
  • Previous respiratory disease or a diagnosed neuromuscular disorder.
  • Pre-operative dysrhythmia.
  • Allergy to neuromuscular blocking agents.
  • Family history of malignant hyperthermia.
  • Decreased renal function (serum creatinine level more than twice the normal range, urine output <0.5 ml kg/h, glomerular filtration ratio <60 ml/ h).

研究组 & 干预措施

deep neuromuscular blockade

Active Comparator

干预措施: Rocuronium (Drug)

deep neuromuscular blockade

Active Comparator

干预措施: nerve stimulator (Device)

moderate neuromuscular blockade

Active Comparator

干预措施: Rocuronium (Drug)

moderate neuromuscular blockade

Active Comparator

干预措施: nerve stimulator (Device)

结局指标

主要结局

Volume of surgical bleeding.

时间窗: Baseline

Volume of surgical bleeding will be recorded before surgical field lavage, and again at the end of surgery, by measuring the total volume of blood collected in the suction bottle minus the lavage fluid volume used for wound irrigation.

次要结局

  • surgeon's satisfaction with the operating conditions(Baseline)

研究者

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

Mohamed Refaat Shaaban Abd El-aal

Principal Investigator

Assiut University

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