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临床试验/NCT00978757
NCT00978757已完成4 期

Phase 4: Study of Ketamine Inhibition of Interleukin 6 in Hepatic Resections Requiring Temporary Porto-arterial Occlusion

Hospital Italiano de Buenos Aires1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2001年6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
入组人数
42
试验地点
1
主要终点
The Effect of Ketamine on Interleukin 6 (IL-6) Synthesis in Hepatic Resections Requiring Temporary Porto-arterial Occlusion (Pringle Maneuver)

研究概览

简要总结

The purpose of this study is to determine whether ketamine is effective to inhibit interleukin 6 synthesis in hepatic resections requiring temporary porto-arterial occlusion.

详细描述

Introduction: Many complications in liver resection surgery, such as post-operative hepatic insufficiency, sepsis, and multi-organ liver failure, have been attributed to ischemia-reperfusion injury and the release of pro-inflammatory agents. Previous studies had shown that ketamine inhibited the synthesis of interleukin 6 (IL-6) in some cardiac surgeries, and that IL-6 levels had a direct correlation with mortality in critically ill patients.

Goal: The purpose of our study was to determine the effect of ketamine on IL-6 levels in patients undergoing liver resections with temporary porto-arterial occlusion (Pringle maneuver).

Material and Methods: Our prospective, controlled, randomized, and blinded study was approved by the Research Ethics Committee of the Hospital Italiano of Buenos Aires (CEPI). All procedures were carried out according to the Declaration of Helsinski. All patients voluntarily consented to the study and signed the appropriate informed consent approved by the CEPI.

Inclusion criteria were age of 21 years or older and planned liver resection with Pringle maneuver lasting 30-60 minutes. Those with chronic illness requiring corticosteroids, cirrhosis, hemodynamic instability prior to the surgery, diabetes, sepsis, surgical interventions or chemotherapy treatments within the past 30 days, pregnancy, illnesses that could potentially affect the hepatic circulation, arterial or ocular hypertension (contraindications for the use of ketamine), ketamine allergy, preoperative portal embolization / radiofrequency ablation, or requiring emergency surgeries were not considered. From March 2002 to June 2008, 44 consecutive patients agreed to participate and were enrolled in the study. Those who did not require the Pringle maneuver during the resection, who did not undergo the planned procedure, or whose hematocrit was less than 20% for over 30 minutes were excluded.

Patients were assigned to one of two groups according to a computer generated randomization.

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, Investigator)

入排标准

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

入选标准

  • Age: 21 or older
  • Planned liver resection with Pringle maneuver lasting 30-60 minutes

排除标准

  • Chronic illness requiring corticosteroids
  • Cirrhosis
  • Hemodynamic instability prior to surgery
  • Surgical interventions or chemotherapy treatments within the past 30 days
  • Pregnancy
  • Illnesses that could potentially affect the hepatic circulation
  • Arterial hypertension
  • Ocular hypertension
  • Allergy to ketamine
  • Preoperative portal embolization
  • Radiofrequency ablation
  • Patients requiring emergency surgeries

研究组 & 干预措施

Ketamine

Experimental

Ketamine: 0.25 mg/kg, intravenously, one dose.

干预措施: Ketamine (Drug)

Placebo

Placebo Comparator

Placebo: saline solution

干预措施: Placebo (Other)

结局指标

主要结局

The Effect of Ketamine on Interleukin 6 (IL-6) Synthesis in Hepatic Resections Requiring Temporary Porto-arterial Occlusion (Pringle Maneuver)

时间窗: Plasma concentration of IL-6 levels were obtained prior to surgery, upon placement of the first intravenous

As an outcome, Interleukin 6 (IL-6) was measured in plasma concentration of hepatic resections requiring temporary porto-arterial occlusion patients.

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

FRANCISCO CARLOS BONOFIGLIO

Anesthesiologist

Hospital Italiano de Buenos Aires

研究点 (1)

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