Status:
COMPLETED
A Safety and Efficacy Study of Dexmedetomidine in Patients Requiring Sedation for Elective Awake Fiberoptic Intubation
Lead Sponsor:
Hospira, now a wholly owned subsidiary of Pfizer
Conditions:
Awake Fiberoptic Intubation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of dexmedetomidine versus placebo used for sedation during elective awake fiberoptic intubation.
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- Obesity
- Known airway pathology
- Known airway malignancy
- Upper airway obstruction
- iii. Trauma
- Face
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT00383890
Start Date
August 1 2006
End Date
March 1 2007
Last Update
July 24 2015
Active Locations (17)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
3
University of Miami Jackson Memorial Hospital
Miami, Florida, United States, 33136
4
University of Illinois Medical Center at Chicago
Chicago, Illinois, United States, 60612