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临床试验/NCT03717467
NCT03717467Unknown不适用

The Influence of Intraoperative Magnesium Sulfate Administration on Postoperative Morphine Requirement in Living Donor During Orthotopic Liver Transplantation

Fayoum University Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年5月8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
入组人数
60
试验地点
1
主要终点
Postoperative Morphine consumption

研究概览

简要总结

The aim of study is to assess the effect of intraoperative use of magnesium sulfate in liver donating patients in reducing post-operative morphine requirements in early postoperative 24 hour in adult living liver donor.The authors hypothesize that magnesium sulfate can be used to efficiently reduce postoperative morphine consumption in the early 24 hours postoperatively as evident in other surgery types.

详细描述

Introduction A lot of recent trials emphasized that perioperative magnesium sulfate (MgSO4) infusion has general anesthetic properties that could reduce anesthetic drug consumption and postoperative analgesia requirements in several types of surgery. Optimal post-operative pain control is necessary for early mobilization, improved respiratory function, and deep venous thrombosis. Administration of multimodal analgesics could limit the excessive use of systemic opioid analgesia especially (morphine), which has a high rate of postoperative side effects as sedation, respiratory depression, ileus, nausea, vomiting, constipation, urine retention, and itching. Therefore, medications and adjuvant drugs reducing the need for opioids have become widely used as parts of multimodal analgesia. Post-operative pain management begins with pre-operative planning and formulating a pain management plan that is tailored to an individual patient's liver function, respiratory and coagulation status, comorbidities and extent of resection.

Anesthetic technique:

Patients will be premedicated with tablet of alprazolam 0.25 mg the night before and 2 hours before surgery. Upon arrival in operating room usual monitoring will be established including heart rate, blood pressure, electrocardiogram (ECG),and temperature. After induction of anesthesia, an arterial line will be inserted for continuous monitoring of blood pressure and frequent blood gas analysis. End-tidal carbon dioxide (capnography) will be attached. General anesthesia will be administered using propofol 2 mg/kg, morphine 0.1 mg/kg and atracurium besylate 0.5 mg/kg followed by oral endotracheal intubation. Maintenance of general anesthesia with a mixture of isoflurane and 50% oxygen in air, morphine 2 mg/ h, mechanical ventilation will be adjusted to keep arterial oxygen saturation < 95 % and end-tidal carbon dioxide between 35 and 40 mmHg. Atracurium (0.15 mg/kg) will be administered every 30 min.

Baseline intravenous infusion rate of lactated ringers solution will be set at (6ml/ kg/h) in both groups, additional solution will be infused if required. Magnesium sulfate infusion and anesthetic agents will be discontinued at the end of operation. The postoperative residual neuromuscular blockade will be reversed by using neostigmine 0.04 mg/kg and atropine 0.02 mg/kg. Then the patient will be extubated and transferred to the post-anesthesia care unit (PACU) for 1-hour observation.

Statistical analysis:

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, Investigator)

盲法说明

Patient will be randomly assigned to one of the two groups. An independent anesthesiologist who will not be participating in the study prepares the study medications.

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age (18-50).
  • American Society of Anesthesiology (ASA) physical state I or II.
  • Normal serum electrolytes.

排除标准

  • Impaired hepatic or renal functions.
  • Various degree of heart block.
  • Hypertension
  • Myopathy or any neurological disorder.
  • History of long term opioid use
  • Patients treated with calcium channel blockers
  • Patients with known allergy to drug used.
  • Pregnant woman
  • Obesity (Body Mass Index > 30).

研究组 & 干预措施

S group

Placebo Comparator

Isotonic saline as placebo will be given.

干预措施: isotonic saline (Drug)

M group

Active Comparator

Magnesium sulfate will be given

干预措施: Magnesium Sulfate (Drug)

结局指标

主要结局

Postoperative Morphine consumption

时间窗: 24 hours after operation

in mg

次要结局

  • Mean arterial pressure(48 hours after end of surgery)
  • Assessment of sedation(48 hours after end of surgery)
  • Interleukin 8 level in blood(24 hours after operation)
  • Tumor necrosis factor alpha level in blood(24 hours after operation)
  • Incidence of respiratory depression(48 hours after operation)
  • Incidence of oversedation(48 hours after operation)
  • Incidence of itching(48 hours after operation)
  • Incidence of paralytic ileus(48 hours after operation)
  • Heart rate(48 hours after end of surgery)
  • Patient satisfaction level(48 hours after end of surgery)
  • Interleukin 6 level in blood(24 hours after operation)
  • Incidence of somnolence(48 hours after operation)
  • Morphine consumption(48 hours after end of surgery)
  • Visual Analog Scale(48 hours after end of surgery)
  • Blood serum magnesium concentration(15 minutes after operation)
  • Incidence of shivering(48 hours after operation)
  • Incidence of vomiting(48 hours after operation)
  • Incidence of nausea(48 hours after operation)
  • Incidence of constipation(48 hours after operation)

研究者

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

Hany M Yassin, MD

Associate professor of anesthesia

Fayoum University Hospital

研究点 (1)

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