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临床试验/NCT06427707
NCT06427707招募中2 期

The Effect of Adding Either Propofol or Ketamine to Magnesium and Lidocaine Infusions As an Opioid Free Anaesthesia on Surgical Field in Patients Undergoing Nasal Surgeries. a Randomized Controlled Trial

Ain Shams University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年6月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
招募中
入组人数
90
试验地点
1
主要终点
surgical field using the average category scale (ACS).

研究概览

简要总结

Nasal surgeries are common day case procedures. Although surgical complications are rare, bleeding decreases surgical field visibility and may cause vascular, orbital or intracranial complications in addition to failure of procedure. So, it is crucial to maintain hypotensive anaesthesia to optimize the surgical field.

详细描述

In this study the investigators compare the effect of; propofol- lidocaine-magnesium and ketamine- lidocaine- magnesium infusions to dexmedetomidine- lidocaine- magnesium infusion on surgical field quality, intraoperative haemodynamics, surgical time, recovery time, sedation score, time to first rescue analgesic and incidence of PONV in patients undergoing nasal surgeries

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • ASA I-II,
  • scheduled for elective nasal surgery

排除标准

  • Patients with uncontrolled hypertension.
  • Patients with cardiac disease.
  • Patients with renal, hepatic or cerebral insufficiency.
  • Patients with coagulopathy or receiving drugs influencing blood coagulation.
  • Anaemia, haemoglobinopathies or polycythemia.
  • Pregnancy.
  • Patients with known sensitivity to any of the study drug.

研究组 & 干预措施

Group PLM (propofol-lidocaine-magnesium)

Active Comparator

intravenous infusion of propofol, lidocaine and magnesium sulfate.

干预措施: Intravenous Infusion of propofol, lidocaine, Magnesium sulfate (Drug)

Group KLM (ketamine-lidocaine-magnesium)

Active Comparator

intravenous infusion of Ketamine, lidocaine and magnesium sulfate

干预措施: Intravenous infusion of ketamine, lidocaine, Magnesium sulfate (Drug)

Group DLM (Dexmeditomidine-lidocaine-magnesium)

Active Comparator

Intravenous infusion of Dexmeditomidine, lidocaine and magnesium sulfate

干预措施: Intravenous infusion of dexmedetomidine, lidocaine, Magnesium sulfate (Drug)

结局指标

主要结局

surgical field using the average category scale (ACS).

时间窗: During the operation

Degree of surgical field bleeding

次要结局

  • sedation using Ramsy sedation score(First hour postoperative)

研究者

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

Rania Maher Hussien, MD

Associate Professor

Ain Shams University

研究点 (1)

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