Effect of Preoperative Nebulized Dexmedetomidine on Hemodynamic Changes in Morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Hemodynamic response to laryngoscope, and pneumoperitoneum.
研究概览
简要总结
This randomized study aims to evaluate the effect of preoperative dexmedetomidine nebulization on blunting hemodynamic response for laryngoscope, intubation and pneumoperitoneum in morbidly obese patients undergoing laparoscopic bariatric surgery.
详细描述
Dexmedetomidine is an α -2 adrenergic agonist that has been proven to attenuate the hemodynamic response to intubation and pneumoperitoneum along with dose sparing effect on opioids and propofol .It has been used in multiple routes such as intravenous, intramuscular, oral, nasal, or intrathecal routes .Inhalation of nebulized drug is noninvasive and associated with high bioavailability .Nebulized Dexmedetomidine may offer an attractive alternative to both intravenous as well as intranasal routes of administration because drug deposition following nebulization takes place over nasal, buccal, as well as respiratory mucosa.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •This study will include 90 adult morbidly obese patients of both sex with BMI (40-50), (ASA) III physical status, aged between 18 -50 years scheduled for elective laparoscopic bariatric surgery under general anesthesia.
排除标准
- •Patient's refusal.
- •Decompensated hepatic or renal or cardiac disease.
- •Expected difficult airway management.
- •Uncontrolled hypertension.
- •Psychiatric disease.
- •Sever pulmonary disorders.
- •Patients on opioid, alcohol, beta-blockers or allergy to any of the study drugs.
研究组 & 干预措施
Control group
Patients of this group will be Nebulized with 3 mL of 0.9% saline 15 minutes before shifting the patients to operation room with face mask 6 L/min in sitting position.
干预措施: Saline (Drug)
Study group
Patients of this group will be Nebulized with Dexmedetomidine (1 mcg/kg) in 3mL of 0.9% saline 15 minutes before shifting the patients to operation room with face mask 6 L/min in sitting position.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Hemodynamic response to laryngoscope, and pneumoperitoneum.
时间窗: Intraoperative
Heart rate (HR) and non-invasive mean arterial blood pressure (MAP) changes before nebulization, after nebulization, immediately after induction, after intubation at (1-3-6 minutes), post-pneumoperitoneum(T0) then every 15 minutes till end of the surgery.
次要结局
- Degree of sedation(Just after nebulization)
- Amount of opioid consumption(24 hours postoperative)
- Postoperative pain(24 hours postoperative)
- Amount of fentanyl consumption(Intraoperative)
研究者
Abdelhamed Ibrahim Abdelhamed Badreldin
Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.
Tanta University