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

Awake Fiberoptic Intubation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00383890
• Other study ID #: 2005-006
• Status: Completed
• Phase: Phase 3
• First received: October 2, 2006
• Last updated: July 23, 2015
• Start date: August 2006
• Est. completion date: March 2007

Study information

• Verified date: July 2015
• Source: Hospira, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00411775

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: March 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 a2-agonist or antagonist;

6. Subject for whom benzodiazepines, dexmedetomidine or other a2-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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Awake Fiberoptic Intubation

Intervention

Drug:
• Dexmedetomidine HCL Injection

• Placebo

Locations

Country	Name	City	State
United States	Lehigh Valley Hospital	Allentown	Pennsylvania
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Illinois Medical Center at Chicago	Chicago	Illinois
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	The Ohio State University Medical Center	Columbus	Ohio
United States	VA North Texas Health Care System	Dallas	Texas
United States	The University of Texas	Houston	Texas
United States	The University of Texas Medical School at Houston	Houston	Texas
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Loma Linda University Medical Center	Loma Linda	California
United States	University of Miami Jackson Memorial Hospital	Miami	Florida
United States	VA Medical Center	Milwaukee	Wisconsin
United States	New York University Medical Center	New York	New York
United States	The Mount Sinai School of Medicine	New York	New York
United States	Mayo Clinic Rochester	Rochester	Minnesota
United States	Scott and White Memorial Hospital	Temple	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Hospira, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of subjects requiring rescue midazolam to achieve and/or maintain proper sedation levels throughout the study drug infusion	Sedation levels (Ramsay Sedation Scale [RSS] score =2 [Patient is cooperative, oriented and tranquil])	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.	No
Secondary	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).	No
Secondary	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).	No
Secondary	Anesthesiologist assessment of ease of subject care		Immediately following discontinuation of study drug, prior to the scheduled surgery/procedure (Approximately 24 hours).	No
Secondary	Subject recall and satisfaction assessed 24 hours post study drug		At the end of the 24-Hour Follow-Up Period	No