CompletedPhase 3

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

United States124 participantsStarted 2006-08

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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:
✓. Prominent protruding teeth
✓. Small mouth opening

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 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.

What they're measuring

The percentage of subjects requiring rescue midazolam to achieve and/or maintain proper sedation levels throughout the study drug infusion

Timeframe: 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.

Trial details

NCT IDNCT00383890

SponsorHospira, now a wholly owned subsidiary of Pfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-01

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