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临床试验/NCT03172065
NCT03172065已完成不适用

The Effect of Adding Intrathecal Dexmedetomidine on Shoulder Tip Pain During Laparoscopic Ovarian Cystectomy Under Bupivacaine Spinal Anaesthesia. Randomised Controlled Study.

Assiut University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年7月1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
60
试验地点
1
主要终点
occurrence shoulder tip pain

研究概览

简要总结

Conventionally General anaesthesia remains the choice for the majority of open abdominal surgical procedures, and regional anaesthesia is preferred only for patients who are at high risk under general anaesthesia . The main reason for selecting spinal anaesthesia as the first choice for laparoscopic cases was its advantages over general anaesthesia which include uniform total muscle relaxation, a conscious patient, economical, relatively uneventful recovery, pain free early postoperative period and the protection from potential complications of general anaesthesia. The main debatable point, however, seems to be the status of respiratory parameters among the two modes of anaesthesia during laparoscopic surgery. In this context it can be stated that spontaneous physiological respiration during spinal anaesthesia would always be better than an assisted respiration as in general anaesthesia.

The pneumo-peritoneum induced rise in intra-abdominal pressure including pressure on the diaphragm and carbon dioxide induced peritoneal irritation are the factors to be considered

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
Double (Participant, Investigator)

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Elective gynaecological laparoscopic surgery
  • Age 20-45 yrs
  • Suspected surgery time 30 minutes
  • Inflation pressure <13 Cm H20

排除标准

  • Contraindications to regional block (infection at the needle insertion site)
  • Altered conscious level.
  • Pregnancy
  • Body mass index >35
  • Height <155 cm
  • Patients who have difficulty understanding the study protocol

研究组 & 干预措施

control group

Other

will receive 3.5 ml (17.5 mg) hyperbaric Bupivacaine + 0.5 ml saline

干预措施: Normal saline (Drug)

Dexmedetomidine group

Other

will receive 3.5 ml (17.5 mg) hyperbaric Bupivacaine + 0.5 ml dexmedetomidine (0.5 mic)

干预措施: Dexmedetomidine (Drug)

结局指标

主要结局

occurrence shoulder tip pain

时间窗: 48 hours

次要结局

  • intraoperative haemodynamic stability, et co2, sao2.(2 hours)

研究者

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

Rasha Hamed

Lecturer of anesthesia

Assiut University

研究点 (1)

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