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A Safety and Efficacy Study of Dexmedetomidine in Patients Requiring Sedation for Elective Awake Fiberoptic Intubation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospira, Inc.
ClinicalTrials.gov Identifier:
NCT00383890
First received: October 2, 2006
Last updated: July 23, 2015
Last verified: July 2015

October 2, 2006
July 23, 2015
August 2006
January 2007   (final data collection date for primary outcome measure)
The percentage of subjects requiring rescue midazolam to achieve and/or maintain proper sedation levels throughout the study drug infusion [ Time Frame: 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. ] [ Designated as safety issue: No ]
Sedation levels (Ramsay Sedation Scale [RSS] score ≥2 [Patient is cooperative, oriented and tranquil])
  • The percentage of subjects requiring rescue midazolam to achieve and/or maintain
  • proper sedation levels throughout the study drug infusion.
Complete list of historical versions of study NCT00383890 on ClinicalTrials.gov Archive Site
  • Total dose of rescue midazolam required to achieve and/or maintain target sedation levels [ Time Frame: During the drug maintenance (i.e, Approximately 15 minutes after starting study drug). ] [ Designated as safety issue: No ]
  • Percentage of subjects requiring additional rescue medications other than midazolam to achieve and/or maintain target sedation levels [ Time Frame: During the drug maintenance (i.e, Approximately 15 minutes after starting study drug). ] [ Designated as safety issue: No ]
  • Anesthesiologist assessment of ease of subject care [ Time Frame: Immediately following discontinuation of study drug, prior to the scheduled surgery/procedure (Approximately 24 hours). ] [ Designated as safety issue: No ]
  • Subject recall and satisfaction assessed 24 hours post study drug [ Time Frame: At the end of the 24-Hour Follow-Up Period ] [ Designated as safety issue: No ]
  • Total dose of rescue midazolam required to achieve and/or maintain target sedation
  • levels; percentage of subjects requiring additional rescue medications other
  • than midazolam to achieve and/or maintain target sedation levels;
  • anesthesiologist assessment of ease of subject care; and subject recall and
  • satisfaction assessed 24 hours post study drug.
Not Provided
Not Provided
 
A Safety and Efficacy Study of Dexmedetomidine in Patients Requiring Sedation for Elective Awake Fiberoptic Intubation
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
The purpose of this study is to evaluate the safety and efficacy of dexmedetomidine versus placebo used for sedation during elective awake fiberoptic intubation.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Awake Fiberoptic Intubation
  • Drug: Dexmedetomidine HCL Injection
  • Drug: Placebo
  • Experimental: Dexmedetomidine
    Dexmedetomidine 1 mcg/kg load for 10 minutes and Dexmedetomidine Maintenance (0.7 mcg/kg/hr) for 15 min
    Intervention: Drug: Dexmedetomidine HCL Injection
  • Placebo Comparator: Placebo (PBO)
    Placebo load for 10 min and Placebo maintenance for 15 min
    Intervention: Drug: Placebo
Bergese SD, Candiotti KA, Bokesch PM, Zura A, Wisemandle W, Bekker AY; AWAKE Study Group.. A Phase IIIb, randomized, double-blind, placebo-controlled, multicenter study evaluating the safety and efficacy of dexmedetomidine for sedation during awake fiberoptic intubation. Am J Ther. 2010 Nov-Dec;17(6):586-95. doi: 10.1097/MJT.0b013e3181d69072.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
124
March 2007
January 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Adult (≥18 years of age);
  2. American Society of Anesthesiologists (ASA) score I - IV inclusive;
  3. Male or female. If female, subject is non-lactating and is either:

    1. 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.
    2. 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.
  4. 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

    1. Prominent protruding teeth
    2. Small mouth opening
    3. Narrow mandible
    4. Micrognathia
    5. Macroglossia
    6. Short, muscular neck
    7. Very long neck
    8. Limited neck extension
    9. Congenital airway anomalies
    10. Obesity
    11. Known airway pathology
    12. Known airway malignancy
    13. Upper airway obstruction

    iii. Trauma

    1. Face
    2. Upper airway
    3. Cervical spine

    iv. Anticipated difficult mask ventilation

    v. Severe risk of aspiration

    vi. Respiratory failure

    vii. Severe hemodynamic instability

  5. Subject (or subject's legally authorized representative) must voluntarily sign and date the informed consent.

Exclusion Criteria:

  1. Previous exposure to any experimental drug within 30 days prior to study drug administration;
  2. Central nervous system (CNS) disease with an anticipated increased intracranial pressure or cerebrospinal fluid (CSF) leak;
  3. Uncontrolled seizure disorder and/or known psychiatric illness that could confound a normal response to sedative treatment;
  4. Presence of acute alcohol intoxication;
  5. Current (within 14 days of study entry) treatment with an α2-agonist or antagonist;
  6. Subject for whom benzodiazepines, dexmedetomidine or other α2-agonists are contraindicated;
  7. Subject received an IV or oral (PO) opioid within one hour or intramuscularly within four hours of the start of study drug administration;
  8. 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.
  9. 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).
  10. Subject has any other condition or factor which, in the Investigator's opinion, might increase the risk to the subject.
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00383890
2005-006
Not Provided
Not Provided
Not Provided
Hospira, Inc.
Hospira, Inc.
Not Provided
Not Provided
Hospira, Inc.
July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP