Awake Intubation - Precedex Used for Sedation During Elective Awake Fiberoptic Intubation - Full Text View

Sponsors and Collaborators:	M.D. Anderson Cancer Center Hospira, Inc.
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00411775

Purpose

The objective 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
Surgical Procedures	Drug: Dexmedetomidine Drug: Placebo	Phase III

Drug Information available for: Dexmedetomidine Dexmedetomidine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

To learn if Precedex (dexmedetomidine) can help to calm the nerves and cause sleep when given before and during an intubation procedure. [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	December 2006
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Dexmedetomidine (Precedex)	Drug: Dexmedetomidine Dexmedetomidine by vein, as a continuous infusion, until the tube in the throat is in place and you are asleep under general anesthesia.
2: Placebo Comparator Placebo	Drug: Placebo Placebo by vein, as a continuous infusion, until the tube in the throat is in place and you are asleep under general anesthesia.

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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
Male or female. If female, subject is non-lactating and is either: (a.) 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. (b.) 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/nasal) intubation because of anticipated difficult airway, as defined by at least one of the following criteria:History of difficult intubation, 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),
(Cont # 4): Trauma (Face, Upper airway, Cervical Spine), Anticipated difficult mask ventilation, Severe risk of aspiration, Respiratory failure, or Severe hemodynamic instability.
Subject (or subject's legally authorized representative) must voluntarily sign and date the informed consent.

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 alpha subscript (2) -agonist or antagonist
Subject for whom benzodiazepines, DEX or other alpha subscript (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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00411775

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Hospira, Inc.

Investigators

Principal Investigator:

Mona Sarkiss, MD, PhD

U.T.M.D. Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Mona Sarkiss, MD, PhD/Assistant Professor )
Study ID Numbers:	2006-0659
Study First Received:	December 14, 2006
Last Updated:	November 18, 2008
ClinicalTrials.gov Identifier:	NCT00411775 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:

Awake Fiberoptic Intubation
Dexmedetomidine
Precedex
Placebo

Study placed in the following topic categories:

Neurotransmitter Agents
Adrenergic alpha-Agonists
Adrenergic Agents
Analgesics, Non-Narcotic
Hypnotics and Sedatives
Central Nervous System Depressants

Anesthetics
Peripheral Nervous System Agents
Analgesics
Dexmedetomidine
Adrenergic Agonists

Additional relevant MeSH terms:

Neurotransmitter Agents
Adrenergic alpha-Agonists
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Pharmacologic Actions
Adrenergic Agonists

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Hypnotics and Sedatives
Dexmedetomidine
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 06, 2009