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

NCT00383890 | Completed Phase 3

• 1 other identifier: 2005-006
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 17

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.

Conditions

Awake Fiberoptic Intubation

Keywords

American Society of Anesthesiologists (ASA); Mallampati Score; Ramsay Sedation Scale (RSS)

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (4)

• 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).

• 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).

• Anesthesiologist assessment of ease of subject care

  Immediately following discontinuation of study drug, prior to the scheduled surgery/procedure (Approximately 24 hours).

• Subject recall and satisfaction assessed 24 hours post study drug

  At the end of the 24-Hour Follow-Up Period

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

Dexmedetomidine 1 mcg/kg load for 10 minutes and Dexmedetomidine Maintenance (0.7 mcg/kg/hr) for 15 min

Drug: Dexmedetomidine HCL Injection

Placebo (PBO)

PLACEBO COMPARATOR

Placebo load for 10 min and Placebo maintenance for 15 min

Drug: Placebo

Interventions

Dexmedetomidine HCL Injection DRUG

Dexmedetomidine

Placebo DRUG

Placebo (PBO)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospira, now a wholly owned subsidiary of Pfizer: lead

Study Sites (17)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

University of Miami Jackson Memorial Hospital

Miami, Florida, 33136, United States

Location

University of Illinois Medical Center at Chicago

Chicago, Illinois, 60612, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

New York University Medical Center

New York, New York, 10016, United States

Location

The Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

The Ohio State University Medical Center

Columbus, Ohio, 43210-1228, United States

Location

Lehigh Valley Hospital

Allentown, Pennsylvania, 18103-6296, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

VA North Texas Health Care System

Dallas, Texas, 75216, United States

Location

The University of Texas Medical School at Houston

Houston, Texas, 77030, United States

Location

The University of Texas

Houston, Texas, 77030, United States

Location

Scott and White Memorial Hospital

Temple, Texas, 76508, United States

Location

VA Medical Center

Milwaukee, Wisconsin, 53295, United States

Location

Related Publications (1)

• 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.

  PMID: 20535016 DERIVED

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2006
• First Posted: October 4, 2006
• Study Start: August 1, 2006
• Primary Completion: January 1, 2007
• Study Completion: March 1, 2007
• Last Updated: July 24, 2015

Record last verified: 2015-07

Locations

US (17)