Effect of Different Doses of Dexmedetomidine on Stress Response and Emergence Agitation After Laparoscopic Cholecystectomy in Adults
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- serum cortisol level
研究概览
简要总结
Emergence agitation is a post-anesthetic phenomenon that develops in the early phase of general anesthesia recovery, and is characterized by agitation, confusion, disorientation, and possible violent behavior. The incidence of emergence agitation is less common in adults as compared to pediatric patients. It may lead to serious consequences for the patient such as bleeding, falling, removal of catheters and self extubation, which lead to further complications like hypoxia and aspiration.
Despite its common occurrence, unclear etiology, and serious sequelae, emergence agitation has rarely been studied in adults.
The stress response to surgery is an unconscious response to tissue injury. Activation of the sympathetic nervous system, increase of catabolic hormone release and pituitary gland suppression are considered a response to surgical stress, in clinical practice these activities cause changes in heart rate, blood pressure and biochemical fluctuations of noradrenaline, adrenaline, dopamine, and cortisol. Above all, these fluctuations prolong hospitalization and delay patients discharge.
Dexmedetomidine is a highly selective alpha-2 receptor agonist having sedative, analgesic and sympatholytic properties. Decreased stress response to surgery ensuring a stable hemodynamic state is a beneficial property of the agent. Peri-operative use of dexmedetomidine also decreases postoperative opioid consumption, pain intensity, and antiemetic therapy. However, the data related to the effects of dexmedetomidine on reducing agitation from general anesthesia in adults are limited.
详细描述
With no premedication, all patients will have pre-oxygenation for 3-5 minutes and intravenous access will be secured. NaCl 0.9% 4 ml/kg/h will be infused intraoperatively. General anesthesia will be induced by fentanyl 1 ug/kg, propofol 2 mg/kg and nimbex (cisatracurium) 0.15 mg/kg. Endotracheal intubation then will be done using oral ETT of appropriate size under direct laryngoscopy and secured at the angle of the mouth. Sevoflurane inhalational anesthetic (2-4 %) and nimbex 0.03 mg/kg will be used for maintenance of anesthesia. The lungs will be mechanically ventilated to keep intra-operative EtCo2 between 35-40 mmHg.
Intraoperative monitoring:
Routine monitors including ECG, non-invasive blood pressure, pulse oxymetry and EtCo2 will be recorded every 5 minutes during the intra-operative 20 minutes of the study drug administration. Bradycadia (heart rate ˂ 60 beat/minute) will be treated with iv atropine 0.5 mg. Hypotension (mean arterial blood pressure ˂ 60 mmHg) will be treated with iv ephedrine 5 mg increments. Duration of anesthesia, sevoflurane % and duration of surgery will be recorded.
At the end of surgery and stoppage of sevoflurane inhalation, neostigmine 0.04 mg/kg and atropine 0.02 mg/kg will be used for muscle relaxant reversal (Time 0 in the emergence process), patients will be extubated and transferred to the PACU for recovery and monitoring.
Assessment in PACU:
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
- Double (Participant, Care Provider)
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
- •ASA I - II Laparoscopic cholecystectomy under general anesthesia
排除标准
- •Patients with cardiac disease, diabetes. reactive upper airway disease. allergies to dexmedetomidine. cognitive disorders. renal insufficiency. hepatic dysfunction. Chronic use of analgesics, cortisone or drugs known to interact with dexmedetomidine.
研究组 & 干预措施
Dexmedetomidine 1
patients will receive dexmedetomidine 1 mic/kg
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine 0.75
patients will receive dexmedetomidine 0.75 mic/kg
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine 0.5
patients will receive dexmedetomidine 0.5 mic/kg
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
serum cortisol level
时间窗: 2 hours postoperative
serum cortisol level will be measured at 2 hours postoperative
次要结局
- post anesthetic emergence agitation(2 hours postoperative)
- visual analogue score(24 hours postoperative)
研究者
MOHAMED F. MOSTAFA
lecturer of anesthesia and intensive care, faculty of medicine, Assiut university
Assiut University