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临床试验/NCT04630938
NCT04630938已完成不适用

Effects of Anesthetics on Inflammatory Markers in Patients Undergoing Abdominal Surgeries.

Assiut University1 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2020年10月24日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
81
试验地点
1
主要终点
Visual analogue score

研究概览

简要总结

undertake confidently both open and laparoscopic cholecystectomy. Major types of body injuries surgical or accidental; evoke a temporary, yet predictable systemic inflammatory response caused by hormonal, immunological and metabolic mediators. This inflammatory response is essential for tissue repair and has evolved to maximize the organisms' healing potential. In healthy individuals the inflammatory response to major surgery is well balanced consisting of pro- and anti-inflammatory mediators. The severity of injury, the occurrence of surgical complications and its accompanying level of stress may hinder the balance of the inflammatory response6.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients aging 18 - 55 years old
  • Patients scheduled for abdominal surgeries
  • Patients with American Society of Anesthesiologists (ASA) I, II physical status

排除标准

  • Patients' refusal.
  • Critically ill patients.
  • Patients who have contraindications to regional anesthesia.

研究组 & 干预措施

G-M

Active Comparator

Received classic general Anesthesia, intrathecal (Bupivacaine 15 mg, morphine 4 microgram/kg) plus saline infusion intraoperative and postoperative.

干预措施: Morphine Sulfate (Drug)

G-ML

Active Comparator

Received classic general Anesthesia, intrathecal morphine in a dose of 4 microgram/kg, and intravenous lidocaine in a loading dose of 1.5 mg/kg, then 2 mg/min with the saline infusion over the time of the operation and the next 4 hours postoperative.

干预措施: morphine+lidocaine (Drug)

G-0

Placebo Comparator

Received General Anesthesia and Spinal anesthesia as previously described with saline infusion in the same design as in the previous two groups.

干预措施: Saline (Drug)

结局指标

主要结局

Visual analogue score

时间窗: 24 hours

a scale to measure pain intensity graded from 0 = no pain to 10 = worst pain

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

Esam Hamed

clinical professor

Assiut University

研究点 (1)

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