Awake Fiberoptic IntubationPhase 3NCT00383890
A Safety and Efficacy Study of Dexmedetomidine in Patients Requiring Sedation for Elective Awake Fiberoptic Intubation
A Phase 3 study testing Dexmedetomidine HCL Injection in people with Awake Fiberoptic Intubation, run by Hospira, now a wholly owned subsidiary of Pfizer at 17 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Awake Fiberoptic Intubation
- What is being tested?
- Dexmedetomidine HCL Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 17 sitesUnited States
- Study dates
- Aug 2006to Mar 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- Criteria for Assessing Difficult Airways
- 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
- Trauma
- Face
- Upper airway
- Cervical spine
- Anticipated difficult mask ventilation
- Severe risk of aspiration
- Respiratory failure
- Severe hemodynamic instability
- Subject (or subject's legally authorized representative) must voluntarily sign and date the informed consent.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103-6296
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Illinois Medical Center at Chicago
Chicago, Illinois, 60612
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
The Ohio State University Medical Center
Columbus, Ohio, 43210-1228
VA North Texas Health Care System
Dallas, Texas, 75216
The University of Texas Medical School at Houston
Houston, Texas, 77030
The University of Texas
Houston, Texas, 77030
University of Kansas Medical Center
Kansas City, Kansas, 66160
Loma Linda University Medical Center
Loma Linda, California, 92354
University of Miami Jackson Memorial Hospital
Miami, Florida, 33136
VA Medical Center
Milwaukee, Wisconsin, 53295
New York University Medical Center
New York, New York, 10016
The Mount Sinai School of Medicine
New York, New York, 10029
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Scott and White Memorial Hospital
Temple, Texas, 76508
About this 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
The purpose of this study is to evaluate the safety and efficacy of dexmedetomidine versus placebo used for sedation during elective awake fiberoptic intubation.
Read the detailed 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.
- Conditions
- Awake Fiberoptic Intubation
- Being tested
- Dexmedetomidine HCL Injection, Placebo
- Keywords
- American Society of Anesthesiologists (ASA), Mallampati Score, Ramsay Sedation Scale (RSS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine HCL InjectionDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | Dexmedetomidine 1 mcg/kg load for 10 minutes and Dexmedetomidine Maintenance (0.7 mcg/kg/hr) for 15 min Receives: Drug: Dexmedetomidine HCL Injection |
| Placebo (PBO) | Placebo comparator | Placebo load for 10 min and Placebo maintenance for 15 min Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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])
Measured: 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
Measured: 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
Measured: During the drug maintenance (i.e, Approximately 15 minutes after starting study drug).
Anesthesiologist assessment of ease of subject care
Measured: 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
Measured: At the end of the 24-Hour Follow-Up Period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2006 (estimated)
- Study startAug 2006
- Primary completionJan 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Awake Fiberoptic IntubationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00383890
- Sponsor's protocol ID
- 2005-006
- Status last verified
- Jul 2015
- First submitted
- 2 Oct 2006
- Last updated
- 24 Jul 2015
- Results posted
- No
Publications
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.
PubMed 20535016
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00383890
- Acronym / sponsor ID
- 2005-006
- Conditions
- Awake Fiberoptic Intubation
- Keywords
- American Society of Anesthesiologists (ASA), Mallampati Score, Ramsay Sedation Scale (RSS)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Hospira, now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Jan 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 4 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and efficacy of dexmedetomidine versus placebo used for sedation during elective awake fiberoptic intubation.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: Dexmedetomidine HCL InjectionDexmedetomidine 1 mcg/kg load for 10 minutes and Dexmedetomidine Maintenance (0.7 mcg/kg/hr) for 15 min |
| Placebo (PBO) | Placebo comparator | Drug: PlaceboPlacebo load for 10 min and Placebo maintenance for 15 min |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (31 listed)
- 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:
- 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
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexmedetomidine HCL Injection | Drug | Dexmedetomidine |
| Placebo | Drug | Placebo (PBO) |
Primary outcome
The percentage of subjects requiring rescue midazolam to achieve and/or maintain proper sedation levels throughout the study drug infusion
Time frame: 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.
Sedation levels (Ramsay Sedation Scale [RSS] score ≥2 [Patient is cooperative, oriented and tranquil])
4 secondary outcomes
Total dose of rescue midazolam required to achieve and/or maintain target sedation levels
Time frame: 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
Time frame: During the drug maintenance (i.e, Approximately 15 minutes after starting study drug).
Anesthesiologist assessment of ease of subject care
Time frame: 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
Time frame: At the end of the 24-Hour Follow-Up Period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2015.
- Derived from this study: PubMed 20535016Bergese 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexmedetomidine HCL Injection in people with Awake Fiberoptic Intubation, run by Hospira, now a wholly owned subsidiary of Pfizer at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 31 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of subjects requiring rescue midazolam to achieve and/or maintain proper sedation levels throughout the study drug infusion (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00383890, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2015.