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

This study has been completed.
Sponsor:
Information provided by:
Hospira, Inc.
ClinicalTrials.gov Identifier:
NCT00383890
First received: October 2, 2006
Last updated: October 8, 2007
Last verified: October 2007
  Purpose

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 Intervention Phase
Awake Fiberoptic Intubation
Drug: Dexmedetomidine
Drug: Midazolam
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Hospira, Inc.:

Primary Outcome Measures:
  • The percentage of subjects requiring rescue midazolam to achieve and/or maintain
  • proper sedation levels throughout the study drug infusion.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 100
Study Start Date: August 2006
Study Completion Date: March 2007
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. Furthermore, 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult (18 years of age);
  • ASA score I - IV inclusive;
  • Requiring awake fiberoptic (oral or nasal) intubation because of anticipated difficult airway

Exclusion Criteria:

  • 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 2-agonist or antagonist;
  • Subject for whom benzodiazepines, DEX or other 2- agonists are contraindicated;
  • Subject received an IV or 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 SGPT (ALT) and/or 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00383890

Locations
United States, Alabama
Birmingham, Alabama, United States
United States, California
Loma Linda, California, United States
United States, Florida
Miami, Florida, United States
United States, Illinois
Chicago, Illinois, United States
United States, Kansas
Kansas City, Kansas, United States
United States, Minnesota
Rochester, Minnesota, United States
United States, New York
New York, New York, United States
United States, Ohio
Cleveland, Ohio, United States
Columbus, Ohio, United States
United States, Pennsylvania
Allentown, Pennsylvania, United States
United States, South Carolina
Charleston, South Carolina, United States
United States, Texas
Dallas, Texas, United States
Houston, Texas, United States
Temple, Texas, United States
United States, Wisconsin
Milwaukee, Wisconsin, United States
Sponsors and Collaborators
Hospira, Inc.
  More Information

No publications provided by Hospira, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00383890     History of Changes
Obsolete Identifiers: NCT00411775
Other Study ID Numbers: 2005-006
Study First Received: October 2, 2006
Last Updated: October 8, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Hospira, Inc.:
American Society of Anesthesiologists (ASA)
Mallampati Score
Ramsay Sedation Scale (RSS)

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

ClinicalTrials.gov processed this record on October 22, 2014