Pre-operative Study the Efficacy of Nebulized Dexmedetomidine on Blunting Hemodynamic Changes During Intubation and Pneumoperitoneum in Morbid Obese Patients During Laparoscopic Bariatric Surgery: Randomized Double Blind Control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Incidence of increase in hemodynamic response
研究概览
简要总结
This study aims to evaluate the effect of preoperative dexmedetomidine nebulization on blunting hemodynamic response for laryngoscope, intubation, pneumoperitoneum, and opioid consumption in morbidly obese patients undergoing laparoscopic bariatric surgery.
详细描述
Obesity is a major global public health issue. Morbidly obese patients have multiple pathophysiological changes that affect most of the body organs in the form of restrictive lung diseases, obstructive sleep apnea (OSA), hypertension, cardiovascular problems, metabolic syndrome, and fatty infiltration of the liver.
Direct laryngoscopy and intubation are noxious stimuli that are associated with transient, unpredictable, and variable hemodynamic changes. This response occurs within 30 seconds after intubation and lasts less than 10 minutes. The consequences of laryngoscopy and intubation may precipitate ischemia, arrhythmias, cerebrovascular stroke, pulmonary oedema, and an increase in the intracranial pressure in the vulnerable group.
Dexmedetomidine is an α2 adrenergic agonist that has been proven to attenuate the hemodynamic response to intubation and pneumoperitoneum, along with a dose-sparing effect on opioids and propofol. It has been used in multiple routes, including intravenous, intramuscular, oral, nasal, and intrathecal routes. Inhalation of the nebulized drug is non-invasive and associated with high bioavailability. Nebulized dexmedetomidine may offer an attractive alternative to both intravenous and intranasal routes of administration, as drug deposition following nebulization occurs over the nasal, buccal, and 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
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 20 to 60 years old.
- •Both sexes.
- •American Society of Anesthesiologists (ASA) Physical Status I-III.
- •Morbidly obese patients with a body mass index (BMI) between 30 and 45.
排除标准
- •Patients' refusal
- •Decompansated hepatic, renal, or cardiac disease
- •Expected difficult airway management
- •Uncontrolled hypertension
- •Psychiatric disease
- •Sever pulmonary disease
- •Patients on opioid, alcohol, beta-blockers, or allergy to any of the study drugs.
研究组 & 干预措施
Dexmedetomidine group
Patients will be nebulized with dexmedetomidine 1 mcg/kg in 3 ml of 0.9 % saline 15 minutes before shifting the patients to the operating room with a face mask 6 L/min in a sitting position.
干预措施: Dexmedetomidine (Drug)
Control group
Patients will be nebulized with 3 ml of 0.9% normal saline 15 minutes before shifting the patients to operation room with face mask 6 L/min in sitting position.
干预措施: Normal Saline (Drug)
结局指标
主要结局
Incidence of increase in hemodynamic response
时间窗: Intraoperatively
Incidence of increase in hemodynamic response, either heart rate, mean arterial pressure, or both.
次要结局
- Preoperative sedation score(Preoperatively)
- Intraoperative fentanyl consumption(Intraoperatively)
- Intraoperative propofol consumption(Intraoperatively)
- Time for first use of rescue analgesia(24 hours postoperatively)
- Total opioid consumption(24 hours postoperatively)
- Incidence of adverse effects(24 hours postoperatively)
研究者
AHMED ABDELAZIZ SHAMA
Assistant Professor of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.
Tanta University