The Effect of Two Different Doses of Dexmedetomidine Infusion on Oxygenation, Lung Mechanics, and Quality of Recovery in Morbidly Obese Patients: A Prospective Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Intraoperative oxygenation
研究概览
简要总结
Compare the effects of two different doses of dexmedetomidine infusion on oxygenation as a primary outcome and on lung mechanics, quality of recovery and perioperative analgesia as secondary outcomes in morbidly obese patients with restrictive lung disease undergoing abdominal surgery.
详细描述
Dexmedetomidine is a selective α2 receptor agonist and has sympatholytic, analgesic, anti-inflammatory and sedative properties. Dexmedetomidine decreased dead space and improved both lung compliance and oxygenation in chronic obstructive pulmonary disease (COPD) patients undergoing lung cancer surgery.
The effects of dexmedetomidine on oxygenation and lung mechanics had been investigated in obstructive lung disease, but there are little information about its effect in morbidly obese patients with restrictive lung disease .
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
- •Body Mass Index above 40 kg/m2 with restrictive lung disease((forced vital capacity) <70% in pre-operative pulmonary function tests), of American Society of anesthesiologists (ASA) physical status II and III.
- •Aged 18-50 years.
- •Scheduled for abdominal surgery.
排除标准
- •Patients with Forced expiratory volume1/forced vital capacity<
- •Uncontrolled cardiac, respiratory, hepatic or renal diseases.
- •Allergy to the study drug
研究组 & 干预措施
Dexmedetomidine 0.6 group
patients will receive a bolus dose of 1µg/kg dexmedetomidine15 minute after endotracheal intubation over 10 minutes followed by continuous infusion of 0.6 mic/kg/hour for one hour.
干预措施: Dexmedetomidine 0.6 (Drug)
Dexmedetomidine 0.3group
patients will receive a bolus dose of 1µg/kg dexmedetomidine 15 minute after endotracheal intubation over 10 minutes followed by continuous infusion of 0.3 mic/kg/hour for one hour.
干预措施: Dexmedetomidine 0.3 (Drug)
Control group
Patients will receive comparable volume of normal saline (0.9%) 15 minute after endotracheal intubation.
干预措施: Saline (Drug)
结局指标
主要结局
Intraoperative oxygenation
时间窗: Intraoperative
Intraoperative oxygenation was assessed by P/F ratio (Arterial oxygen tension/fraction of inspired oxygen) at baseline and the end of drug infusion.
次要结局
- Dynamic Lung compliance(Intraoperative)
- Quality of recovery score(24 hours Postoperatively)
- Time to first rescue analgesia(24 hours Postoperatively)
- Plateau pressure(Intraoperative)
- Lung compliance(24 hours)
- Post-operative pain(24 hour postoperatively)
- Dead space (dead space to tidal volume)(Intraoperative)
- Static lung compliance(Intraoperative)
研究者
Zeinab Tawfik
Assistant lecturer in Anesthesiology, Surgical ICU and Pain Medicine
Tanta University