A Randomized Double-Blind Trial Comparing Lidocaine and Dexmedetomidine Infusions for Intraoperative Bleeding in Patients Undergoing Functional Endoscopic Sinus Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Surgical field
研究概览
简要总结
This work aims to compare lidocaine and dexmedetomidine infusions for intraoperative bleeding in patients undergoing functional endoscopic sinus surgery.
详细描述
Sinus surgery is one of the most prevalent surgeries on the ear, nose, and throat (ENT). It is mainly carried out through endoscopy and significantly improves the clinical symptoms of patients with rhinosinusitis. Safe conditions must be maintained for this surgery, and the major problem reported during functional endoscopic sinus surgery (FESS) under general anesthesia (GA) is impaired visibility due to excessive bleeding.
Dexmedetomidine is an α2-adrenoceptor agonist with sedative, anxiolytic, sympatholytic, analgesic-sparing effects and minimal depression of respiratory function. It is potent and highly selective for α2-receptors.
Lidocaine is an amino amide-type short-acting local anesthetic (LA). It has a short half-life and a favorable safety profile and is,, therefore,, the LA of choice for continuous IV administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 18 to 65 years old.
- •American Society of Anesthesiologists (ASA) physical status I - II.
- •Scheduled for elective functional endoscopic sinus surgery.
排除标准
- •Diabetes mellitus.
- •Coagulation disorders.
- •Kidney and liver dysfunction.
- •Cerebrovascular disease.
- •Cardiovascular problems.
- •High blood pressure.
- •Chronic obstructive pulmonary disease (COPD).
- •End organ damage.
- •Psychosis.
- •Taking antipsychotic drugs.
- •Allergy to study drugs.
- •Substance abuse.
- •Taking beta blockers.
- •Heart rate of < 55 beat/minute.
研究组 & 干预措施
Lidocaine group
Patients will receive lidocaine (1.5 mg/kg loading then 1mg/kg/h infusion) just after induction of anesthesia induction and continued until the end of the operation.
干预措施: Lidocaine (Drug)
Dexmedetomidine group
Patients will receive 1 μg/kg dexmedetomidine infusion over 10 min as a loading dose then 0.4-0.7 μg/kg/h just after induction of anesthesia induction and continued until the end of the operation.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Surgical field
时间窗: Intraoperatively
Surgical field will be assessed by Fromme et al. scale. (0-no bleeding, 1-slight bleeding, no suctioning of blood required, 2-slight bleeding occasional suctioning required, surgical field not threatened, 3-slight bleeding - frequent suctioning required. Bleeding threatens surgical field as few seconds after suction will be removed, 4-moderate bleeding - frequent suctioning required, bleeding threatens surgical field directly after suction will be removed, 5-severe bleeding - constant suctioning required, bleeding appeared faster than removed by suction. The surgical field severely threatened, and surgery not possible). The ideal category scale value will be determined to be ≤3.
次要结局
- Mean arterial pressure(Till the end of surgery (Up to 4 hours))
- Total morphine consumption(24 hours postoperatively)
- Heart rate(Till the end of surgery (Up to 4 hours))
- Incidence of adverse events(24 hours postoperatively)
- Degree of patient satisfaction(24 hours postoperatively)
- Time to the first request for the rescue analgesia.(24 hours postoperatively)
- Degree of pain(24 hours postoperatively)
研究者
Ahmed Monier Ahmed Youssef Eldemerdash
Lecturer of Anesthesia, Intensive care, and pain management Faculty of Medicine Ain Shams University
Ain Shams University