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临床试验/NCT04256057
NCT04256057Unknown早期 1 期

Effect of Intraoperative Magnesium Infusion on Postoperative Pain and Cognitive Function After Pelvi-abdominal Surgeries :an Observational Study

Beni-Suef University3 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2020年3月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
入组人数
24
试验地点
3
主要终点
magnesium infusion on postoperative cognitive functions in adult patients after elective pelvi-abdominal surgeries.

研究概览

简要总结

The aimof this study is to observe the effect of intraoperative magnesium infusion on peri-operative pain and postoperative cognitive functions in adult patients after elective pelvi-abdominal surgeries.

详细描述

This study will be conducted at Beni-Suef University Hospital after approval of the anesthesiology, surgical ICU and pain management department, and the local ethics and research committee, and obtaining written informed consents from the patients .

The inclusion criteria:

  1. Male and female patients (age 20-60 years)
  2. American Society of Anesthesiology(ASA) physical status I-II
  3. Patients scheduled for elective pelvi-abdominal surgeries

The Exclusion criteria

  1. Patients having significant cardiovascular (cardiomyopathy or moderate to severe valvular heart lesion) , significant hepatic disease (Child-Pugh score B or C ), renal or CNS disease
  2. Patients with uncontrolled hypertension or diabetes
  3. History of hypersensitivity to the drugs to be used
  4. Control MMSE score ≤23
  5. Women who are pregnant or breastfeeding
  6. Patients taking Ca2+ channel blockers, opioids, antidepressants, or antipsychotics or alcohol
  7. Patients having difficulty understanding , vision or hearing problems or CNS disorder as parkinson's disease .
  8. Morbidly obese patients with a body mass index of >40
  9. Patients who refused to be involved within the scope of the research. Management of the patients in the operation room All patients will be informed about the tests and written informed consent will be obtained from each of them. The MMSE will be applied. After arrival to the operation theater the monitors will be applied including will be applied including 5 leads ECG, non invasive arterial blood pressure and pulse oximetry. Urinary catheter will be inserted for urine output monitoring. Train of four (TOF) monitoring and Bispectral index (BIS) monitoring will be done in order to evaluate the depth of hypnosis (A-2000 Bispectral Index, Aspect Medical Systems, the Netherlands).

研究设计

研究类型
Interventional
干预模型
Sequential
主要目的
Diagnostic
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

  • Male and female patients (age 20-60 years)
  • American Society of Anesthesiology(ASA) physical status I-II
  • Patients scheduled for elective pelvi-abdominal surgeries

排除标准

  • Patients having significant cardiovascular (cardiomyopathy or moderate to severe valvular heart lesion) , significant hepatic disease (Child-Pugh score B or C ), renal or CNS disease
  • Patients with uncontrolled hypertension or diabetes
  • History of hypersensitivity to the drugs to be used
  • Control MMSE score ≤23
  • Women who are pregnant or breastfeeding
  • Patients taking Ca2+ channel blockers, opioids, antidepressants, or antipsychotics or alcohol
  • Patients having difficulty understanding , vision or hearing problems or CNS disorder as parkinson's disease .
  • Morbidly obese patients with a body mass index of >40
  • Patients who refused to be involved within the scope of the research.

研究组 & 干预措施

magnesium sulphate

Other

After the induction of anesthesia, a loading dose of magnesium sulfate 50mg/kg in 100mL of isotonic saline as within 5 to 10 minutes followed by a maintenance dose of 10 mg/kg/hr up to the end of surgery

干预措施: Magnesium Sulfate (Drug)

结局指标

主要结局

magnesium infusion on postoperative cognitive functions in adult patients after elective pelvi-abdominal surgeries.

时间窗: the observation will be for 24 hours

After the induction of anesthesia, a loading dose of magnesium sulfate 50mg/kg in 100mL of isotonic saline as within 5 to 10 minutes(23) followed by a maintenance dose of 10 mg/kg/hr up to the end of surgery

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

Samaa Rashwan

Samaa Abou Alkassem Rashwan

Beni-Suef University

研究点 (3)

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