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

Completed · Phase 3 · Has a placebo group

Conditions studied: Awake Fiberoptic Intubation

In brief

The purpose of this study is to evaluate the safety and efficacy of dexmedetomidine versus placebo used for sedation during elective awake fiberoptic intubation.

Key facts

Study ID

NCT00383890

Run by

Hospira, now a wholly owned subsidiary of Pfizer

People needed

124

Starts

2006-08-01

Expected to finish

2007-03-01

Last updated by the study team

2015-07-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• Very long neck
• Limited neck extension
• Congenital airway anomalies
• Obesity
• Known airway pathology
• Known airway malignancy
• Upper airway obstruction
• iii. Trauma
• Face
• Upper airway

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.

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.