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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00383890
Recruitment Status : Completed
First Posted : October 4, 2006
Last Update Posted : July 24, 2015
Information provided by (Responsible Party):
Hospira, now a wholly owned subsidiary of Pfizer

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.

Condition or disease Intervention/treatment Phase
Awake Fiberoptic Intubation Drug: Dexmedetomidine HCL Injection Drug: Placebo Phase 3

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 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2006
Actual Primary Completion Date : January 2007
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Dexmedetomidine
Dexmedetomidine 1 mcg/kg load for 10 minutes and Dexmedetomidine Maintenance (0.7 mcg/kg/hr) for 15 min
Drug: Dexmedetomidine HCL Injection
Placebo Comparator: Placebo (PBO)
Placebo load for 10 min and Placebo maintenance for 15 min
Drug: Placebo

Primary Outcome Measures :
  1. 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. ]
    Sedation levels (Ramsay Sedation Scale [RSS] score ≥2 [Patient is cooperative, oriented and tranquil])

Secondary Outcome Measures :
  1. 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). ]
  2. 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). ]
  3. Anesthesiologist assessment of ease of subject care [ Time Frame: Immediately following discontinuation of study drug, prior to the scheduled surgery/procedure (Approximately 24 hours). ]
  4. Subject recall and satisfaction assessed 24 hours post study drug [ Time Frame: At the end of the 24-Hour Follow-Up Period ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00383890

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
United States, Florida
University of Miami Jackson Memorial Hospital
Miami, Florida, United States, 33136
United States, Illinois
University of Illinois Medical Center at Chicago
Chicago, Illinois, United States, 60612
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
United States, New York
New York University Medical Center
New York, New York, United States, 10016
The Mount Sinai School of Medicine
New York, New York, United States, 10029
United States, Ohio
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210-1228
United States, Pennsylvania
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18103-6296
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
VA North Texas Health Care System
Dallas, Texas, United States, 75216
The University of Texas Medical School at Houston
Houston, Texas, United States, 77030
The University of Texas
Houston, Texas, United States, 77030
Scott and White Memorial Hospital
Temple, Texas, United States, 76508
United States, Wisconsin
VA Medical Center
Milwaukee, Wisconsin, United States, 53295
Sponsors and Collaborators
Hospira, now a wholly owned subsidiary of Pfizer

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hospira, now a wholly owned subsidiary of Pfizer Identifier: NCT00383890     History of Changes
Obsolete Identifiers: NCT00411775
Other Study ID Numbers: 2005-006
First Posted: October 4, 2006    Key Record Dates
Last Update Posted: July 24, 2015
Last Verified: July 2015

Keywords provided by Hospira, now a wholly owned subsidiary of Pfizer:
American Society of Anesthesiologists (ASA)
Mallampati Score
Ramsay Sedation Scale (RSS)

Additional relevant MeSH terms:
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action