A Randomized, Double-Blind Comparison Of Dexmedetomidine And Remifentanil For Sedation During Awake Fiberoptic Intubations
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Patient's reaction to procedure, as it occurs, ie. grimace, gag, verbalized pain.
研究概览
简要总结
The objective of this study is to determine the efficacy and safety of Dexmedetomidine, a selective alpha-2 adrenoceptor agonist, which has recently gained increased popularity for ICU and intraoperative sedation as a sedative during awake fiberoptic intubation, as compared to Remifentanil.
The hypothesis is that Dexmedetomidine will provide at least equal if not better conditions (sedation and analgesia) required for awake fiberoptic intubation (Ramsay Sedation Scale 3) with less respiratory and cardiovascular adverse effects, as well as less recall than Remifentanil.
详细描述
Awake nasal or oral fiberoptic intubation remains the method of choice for airway management in the expected difficult airway. This technique requires that a patient be comfortable, relaxed, cooperative and able to maintain their airway with spontaneous ventilation.
In order to achieve these conditions, the pharmacologic agent chosen for sedation should be short acting and highly titratable, provide the required amount of sedation and have little suppression of spontaneous ventilation. There have been numerous reports of the use of Remifentanil and Propofol used either alone or in combination to achieve this level of sedation.
Remifentanil has the following advantages which makes it a useful drug for this purpose:
- Ultra short acting with a constant half life
- Anti-tussive effects which help prevent coughing with tracheal manipulation
- Reversible with an antagonist naloxone
- Attenuates cardiovascular responses to laryngoscopy
Shortcomings of Remifentanil include undesirable side effects, such as hemodynamic instability and respiratory depression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A signed informed consent must be obtained after the nature of the study has been fully explained.
- •Patients undergoing any procedure requiring general anesthesia with an endotracheal tube.
- •Patients that have been assessed by an attending anesthesiologist to have an airway requiring awake fiberoptic intubation.
- •Adult patients > 18 yrs. old, ASA I - III.
排除标准
- •Patients expected to have severe adverse side effects to Dexmedetomidine including:
- •Previous allergy to the drug.
- •3rd degree AV Block
- •Hypovolemic hypotension
- •Systemic vasoconstriction
- •Patients expected to have a severe adverse side effect to Remifentanil. This includes:
- •Previous allergy to the drug.
- •Patients suspected of being overly sensitive to narcotics.
- •Patients with significant cardiovascular disease or ASA physical status IV and V
结局指标
主要结局
Patient's reaction to procedure, as it occurs, ie. grimace, gag, verbalized pain.
时间窗: duration of intubation
Memory recall
时间窗: post operative, immediately every 30 min for 3 hours and 24 hours
次要结局
- NIBP(duration of intubation and first 15 minutes of surgery)
- HR(duration of intubation and first 15 minutes of surgery)
- Cardiac rhythm(duration of surgery)
- Oxygen saturation(duration of intubation and first 15 minutes of surgery)
- End-tidal carbon dioxide(duration of intubation and first 15 minutes of surgery)
- Continuous ECG(duration of intubation and first 15 minutes of surgery)
- Pulse oximetry(duration of intubation and first 15 minutes of surgery)
- Bispectral index(duration of intubation)
- Respiratory rate(duration of intubation and first 15 minutes of surgery)
研究者
Carin A. Hagberg
Professor and Chairman, Joseph C. Gable, MD Endowed Chair
The University of Texas Health Science Center, Houston