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临床试验/NCT05880732
NCT05880732已完成不适用

The Effect of Preemptive Magnesium Sulfate on Postoperative Pain in Patients Undergoing Mastectomy

Pamukkale University1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2021年1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
68
试验地点
1
主要终点
Postoperative pain was measured and recorded with the Verbal Numeric Rating Scale

研究概览

简要总结

Breast cancer is the most diagnosed type of cancer in women in Turkey and in the world. According to the World Health Organization data, the rate of newly diagnosed breast cancer was reported as 11.6% in 20181. Acute postoperative pain occurs in 40% of patients undergoing surgery for breast cancer2. In the early postoperative period, opioids are commonly used analgesics in the treatment of pain, but they have various side effects such as gastrointestinal, urinary and respiratory symptoms3. Non-opioid analgesics can be used to reduce opioid use and thus limit its side effects. Magnesium sulfate (MgSO4) is an N-Methyl D-Aspartate (NMDA) receptor antagonist that has been used for postoperative analgesia and reducing both the duration and intensity of pain by preventing central sensitization in response to peripheral painful stimulus4-9. The primary aim of this study is to investigate the postoperative analgesic efficacy of MgSO4 in patients who were scheduled for mastectomy with the diagnosis of breast cancer. The secondary aim of our study is to evaluate the changes in perioperative vital signs that may occur due to MgSO4.

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 (Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Female breast cancer patients scheduled for mastectomy and modified radical mastectomy
  • 18≥ years and
  • Patients with ASA score I-II

排除标准

  • The patient who refused the study
  • Drug allergy
  • Unregulated diabetes mellitus and hypertension
  • Cardiac failure with <45% ejection fraction
  • Renal failure (serum creatinine > 2 mg/dL)
  • Liver failure (blood transaminase values 2 fold higher than normal)
  • Psychiatric or neurological disorders
  • Communication difficulties with patient
  • Calcium channel blockers or narcotic drugs uses before surgery

研究组 & 干预措施

Group I

Experimental

The study group (Group I) was given 50 mg/kg MgSO4 in 250 ml of isotonic 30 minutes before induction,

干预措施: Magnesium Sulfate (Drug)

Group II

Placebo Comparator

the control group (Group II) was given only 250 ml of normal saline isotonic solution 30 minutes before induction,

干预措施: normal saline isotonic solution (Drug)

结局指标

主要结局

Postoperative pain was measured and recorded with the Verbal Numeric Rating Scale

时间窗: 24 hours

Postoperative pain was measured and recorded with the Verbal Numeric Rating Scale (VNRS) (0 no pain-10 very 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

Ilknur Hatice Akbudak, MD

assistant professor doctor

Pamukkale University

研究点 (1)

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