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临床试验/NCT04196946
NCT04196946已完成不适用

Comparison of Bupivacaine-Fentanyl and Bupivacaine-Alfentanil Used Intrathecally in Laparoscopic Appendectomy Surgery

Nigde Omer Halisdemir University0 个研究点目标入组 50 人开始时间: 2013年9月2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
发起方
入组人数
50
主要终点
Patients diagnosis with appendicitis

研究概览

简要总结

Acute appendicitis which is the most common cause of acute abdominal pain, is an acute inflammation of appendix vermiformis. Appendectomy operations can be performed as laparoscopic and open surgery. Addition of opioids to intrathecal local anesthetics to improve the quality of preoperative analgesia is an increasingly used method in recent years. The aim of this study is to compare bupivacaine-fentanyl and bupivacaine-alfentanil which are used intrathecally to create motor and sensory block. 50 volunteer patients who were diagnosed as appendicitis by laboratory tests and clinical diagnostic methods in general surgery clinic and classified as American Society of Anesthesiologists Classification I-II (ASA Class I-II) aged between 20-60 years scheduled for laparoscopic appendectomy operation, were included in this study. The patients were randomly assigned into two groups, Group I and Group II. Patients received spinal anesthesia with either 10 mg heavy bupivacaine (2 cc)+25 mcg fentanyl (0.5 cc) intrathecally (Group I, n=25) or 10 mg heavy bupivacaine (2 cc)+250 mcg alfentanil (0.5 cc) intrathecally (Group II, n=25).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals who will undergo laparoscopic appendectomy operation and volunteer to participate in the study were included.

排除标准

  • Individuals who meet the criteria but are not volunteers
  • Previously underwent appendectomy

研究组 & 干预措施

Group I

Experimental

25 mcg fentanyl intrathecally

干预措施: 25 mcg fentanyl (Drug)

Group II

Experimental

250 mcg alfentanil intrathecally

干预措施: 250 mcg alfentanil (Drug)

结局指标

主要结局

Patients diagnosis with appendicitis

时间窗: With the completion of laparoscopic appendectomy operation, average 30 minutes to 1 hour

50 volunteer patients diagnosis with appendicitis by laboratory tests and clinical diagnosis methods in general surgery clinic, aged 20-60 years with American Society of Anesthesiologists Classification I-II (ASA I-II) without contraindication for spinal anesthesia, scheduled for laparoscopic appendectomy operation were included. The patients were randomly assigned into two group.

次要结局

未报告次要终点

研究者

发起方
Nigde Omer Halisdemir University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mehtap Balcı

Anesthesiology and Reanimation Specialist

Nigde Omer Halisdemir University

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