Dexmedetomidine Versus Remifentanil Target Controlled Infusion for Sedation During Awake Fibreoptic Nasotracheal Intubation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Endoscopy Scores
研究概览
简要总结
The purpose of this study is to compare the sedation effect of dexmedetomidine and target controlled remifentanil for awake nasotracheal fibreoptic intubation in patients undergoing oral maxillofacial surgery.
详细描述
Awake fibreoptic nasotracheal intubation is an effective technique for the management of patients with difficult airways undergoing oral maxillofacial surgery. Both optimal intubating conditions and patient comfort are paramount while preparing the patient for fibreoptic intubation. One challenge associated with procedure is to provide adequate sedation while maintaining patients' airway ventilation. Dexmedetomidine, because of its sedative,analgesic properties and minimal influence on patients' ventilation, might be a useful management for it. While with the development of target controlled infusion (TCI) technology, remifentanil sedation becomes a potential sedation in clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA grade I-III adult patients with difficult airway, who were undergoing elective oral maxillofacial surgery
排除标准
- •pregnant or lactating female,
- •long-term opioids or sedative medication,
- •patients < 18 years of age,
- •severe bradycardia (HR < 50 beats/min),
- •hypotension (systolic pressure < 90mmHg),
- •any type of atrioventricular block on the ECG
研究组 & 干预措施
dexmedetomidine
a loading dose (1.5mcg/kg) infused over10 min followed by a continuous infusion of 0.7 μg/kg/h
干预措施: dexmedetomidine group (Drug)
remifentanil
The initial target was 3.0 ng/ml and the TCI was adjusted by 0.5 ng/ml after the target concentration at the effect site had equilibrated with the plasma concentration, until the desired level of sedation was acheived.
干预措施: remifentanil group (Drug)
结局指标
主要结局
Endoscopy Scores
时间窗: during the procedure of fibreoptic and tracheal intubation
Endoscopy was graded from 0 to 5, with lower scores indicating a possibly better condition. Endoscopy score 0 1 2 3 4 5: 1)Grimacing 2)localising 3)Coughing on lignocaine via scope 4)Coughing on entering infraglottic space 5)Prolonged coughing
Intubation Score
时间窗: during the inserting of the tracheal tube
graded from 0 to 5, with lower scores indicating better conditions Intubation score 0 1 2 3 4 5: 1)Grimacing when tube in nares 2)Localising with one limb at any stage 3)Localising with two limbs at any stage 4)Coughing on entering trachea 5)Prolonged coughing
次要结局
- Patient's Reaction to Procedure(the duration of intubation, an expected average of 10 minutes)
- Post Operative Visit(24 hours)
- Mean Arterial Blood Pressure(15 minutes before intubation, endoscopy point, intubation point)
- Heart Rate(15 minutes before intubation, endoscopy point, intubation point)
- Peripheral Oxygen Saturation(SPO2)(15 minutes before intubation, endoscopy point, intubation point)
- Cardiac Rhythm(15 minutes before intubation and duration of intubation)
- Post Intubation Score(immediately after the intubation)
研究者
Rong Hu
consultant in anesthesilogy department of Shanghai 9th People's Hospital
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University