A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Dexmedetomidine Used for Sedation During Elective Awake Fiberoptic Intubation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 124
- 试验地点
- 17
- 主要终点
- The percentage of subjects requiring rescue midazolam to achieve and/or maintain proper sedation levels throughout the study drug infusion
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of dexmedetomidine versus placebo used for sedation during elective awake fiberoptic intubation.
详细描述
An awake fiberoptic intubation is indicated for any patient with an anticipated difficult airway because of their anatomy, airway trauma, morbid obesity, or unstable cervical spine injuries. An awake fiberoptic intubation in a non-sedated patient can be extremely stimulating, uncomfortable, and unpleasant. The clinician must focus on maintaining spontaneous breathing, hemodynamic stability, and the patient's comfort. The term "awake" fiberoptic intubation is used to distinguish this procedure from fiberoptic intubations performed under general anesthesia. Although patients may be sedated for "awake" fiberoptic intubation, they need to be responsive and capable of maintaining their own airway without assistance. Vital components of a successful awake fiberoptic intubation include an anesthesiologist experienced in this technique, adequate topicalization of the airway, and a sedated yet cooperative subject.
Benzodiazepines, combined with opioid, are commonly used for anxiolysis and/or analgesia during awake fiberoptic intubations.
Dexmedetomidine has sympatholytic, sedative, analgesic, and anxiolytic effects that attenuate the catecholamine response to perioperative stress. Dexmedetomidine sedates patients by decreasing sympathetic activity and the level of arousal. Further more, dexmedetomidine has been found to facilitate a decrease in salivary secretion, a desirable effect during fiberoptic intubations.
An estimated 100 subjects (50 DEX, 50 PBO) scheduled for an elective awake fiberoptic intubation because of a potentially difficult airway will be randomized prior to intubation at approximately 18 investigative sites.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
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
- •Adult (≥18 years of age);
- •American Society of Anesthesiologists (ASA) score I - IV inclusive;
- •Male or female. If female, subject is non-lactating and is either:
- •Not of childbearing potential, defined as post-menopausal for at least 1 year or surgically sterile due to bilateral tubal ligation, bilateral oophorectomy or hysterectomy.
- •Of childbearing potential but is not pregnant at time of baseline and is practicing one of the following methods of birth control: oral or parenteral contraceptives, double-barrier method, vasectomized partner, or abstinence from sexual intercourse.
- •Requiring awake fiberoptic (oral or nasal) intubation because of anticipated difficult airway. Subjects must meet at least one of the criteria listed below:
- •Criteria for Assessing Difficult Airways
- •i. History of difficult intubation
- •ii. Anticipated difficult airway
- •Prominent protruding teeth
- •Small mouth opening
- •Narrow mandible
- •Micrognathia
- •Macroglossia
- •Short, muscular neck
- •Very long neck
- •Limited neck extension
- •Congenital airway anomalies
- •Known airway pathology
- •Known airway malignancy
- •Upper airway obstruction
- •iii. Trauma
- •Upper airway
- •Cervical spine
- •iv. Anticipated difficult mask ventilation
- •v. Severe risk of aspiration
- •vi. Respiratory failure
- •vii. Severe hemodynamic instability
- •Subject (or subject's legally authorized representative) must voluntarily sign and date the informed consent.
排除标准
- •Previous exposure to any experimental drug within 30 days prior to study drug administration;
- •Central nervous system (CNS) disease with an anticipated increased intracranial pressure or cerebrospinal fluid (CSF) leak;
- •Uncontrolled seizure disorder and/or known psychiatric illness that could confound a normal response to sedative treatment;
- •Presence of acute alcohol intoxication;
- •Current (within 14 days of study entry) treatment with an α2-agonist or antagonist;
- •Subject for whom benzodiazepines, dexmedetomidine or other α2-agonists are contraindicated;
- •Subject received an IV or oral (PO) opioid within one hour or intramuscularly within four hours of the start of study drug administration;
- •Subject has acute unstable angina, laboratory confirmed acute myocardial infarction within the past 6 weeks, heart rate <50 bpm, systolic blood pressure (SBP) <90 mmHg, or complete heart block unless they have a pacemaker.
- •Subject has elevated serum glutamic pyruvate aminotransferase/alanine transaminase (SGPT/ALT) and/or Serum glutamic oxaloacetic transaminase/ aspartate aminotransferase (SGOT/AST) values of ≥2 times the upper limit of normal (ULN).
- •Subject has any other condition or factor which, in the Investigator's opinion, might increase the risk to the subject.
研究组 & 干预措施
Dexmedetomidine
Dexmedetomidine 1 mcg/kg load for 10 minutes and Dexmedetomidine Maintenance (0.7 mcg/kg/hr) for 15 min
干预措施: Dexmedetomidine HCL Injection (Drug)
Placebo (PBO)
Placebo load for 10 min and Placebo maintenance for 15 min
干预措施: Placebo (Drug)
结局指标
主要结局
The percentage of subjects requiring rescue midazolam to achieve and/or maintain proper sedation levels throughout the study drug infusion
时间窗: At baseline and 15 minutes after starting study drug (prior to topicalization), and every 3 minutes thereafter throughout study drug infusion, at the end of topicalization, and prior to administration of any rescue medication.
Sedation levels (Ramsay Sedation Scale \[RSS\] score ≥2 \[Patient is cooperative, oriented and tranquil\])
次要结局
- Total dose of rescue midazolam required to achieve and/or maintain target sedation levels(During the drug maintenance (i.e, Approximately 15 minutes after starting study drug).)
- Percentage of subjects requiring additional rescue medications other than midazolam to achieve and/or maintain target sedation levels(During the drug maintenance (i.e, Approximately 15 minutes after starting study drug).)
- Anesthesiologist assessment of ease of subject care(Immediately following discontinuation of study drug, prior to the scheduled surgery/procedure (Approximately 24 hours).)
- Subject recall and satisfaction assessed 24 hours post study drug(At the end of the 24-Hour Follow-Up Period)