Comparison of Two Sedation Regimens for Awake Fiberoptic Intubation
NCT ID: NCT05736198
Last Updated: 2024-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
96 participants
OBSERVATIONAL
2024-08-12
2034-03-01
Brief Summary
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In addition to midazolam and fentanyl study subjects will also receive either dexmedetomidine or a placebo (a salt solution that contains no drug). It is believed that dexmedetomidine will not slow down breathing as much as the combination of the valium-like drug and narcotic. In our study, we are trying to determine if this is the best drug for sedation during an awake fiberoptic procedure.
Detailed Description
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After obtaining informed consent, patients will be randomized into one of two groups. The first group will receive placebo, midazolam, and fentanyl (titrated to effect) to facilitate the intubation. The second group will receive dexmedetomidine, midazolam, and fentanyl (titrated to effect) to facilitate intubation. Both groups will have a transtracheal injection and/or direct topical application of lidocaine to decrease irritation of the trachea and vocal cords.
As the patients in the study all have potentially difficult airways, the usual precautions will be taken to minimize the risks to the patients. These include the availability of alternative airway devices (including LMAs and Intubating LMA systems). Doses of dexmedetomidine will conform to the recommended dosing schedules of between 0.3 and 0.7 mcg/kg/hour.
All the drug stated above are currently FDA approved and are used according to the standard of care.
Patient medical records will be reviewed to determine the amount of fentanyl that was used to facilitate intubation as well as homodynamic stability during the procedure and oxygen saturation. A brief 5-minute survey will be conducted 24 hours after the surgery to access patient satisfaction with intubation procedure. Intubation conditions stated below will be recorded by the anesthesiologist during the procedure.
The intubating conditions (gagging, discomfort of patient, and oxygen saturation) and hemodynamic stability during the procedure will be recorded by the research assistant and the patient's satisfaction with the undertaking (after the surgery is completed) will be determined as well. The amount of fentanyl used to facilitate intubation will also be recorded.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Dexmedetomidine
Dexmedetomidine, midazolam, and fentanyl (titrated to effect) to facilitate intubation
Dexmedetomidine
dexmedetomidine, midazolam, and fentanyl (titrated to effect) to facilitate intubation
Placebo
Normal Saline, midazolam, and fentanyl (titrated to effect) to facilitate the intubation
No interventions assigned to this group
Interventions
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Dexmedetomidine
dexmedetomidine, midazolam, and fentanyl (titrated to effect) to facilitate intubation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
18 Years
ALL
No
Sponsors
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University of Illinois at Chicago
OTHER
Responsible Party
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David Glick
Department of Anesthesiology Head
Principal Investigators
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David Glick, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Anesthesiology Head
Locations
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University of Illinois
Chicago, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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Alexandra Barabanova, MS
Role: primary
References
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Scher CS, Gitlin MC. Dexmedetomidine and low-dose ketamine provide adequate sedation for awake fibreoptic intubation. Can J Anaesth. 2003 Jun-Jul;50(6):607-10. doi: 10.1007/BF03018650.
Other Identifiers
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2023-0181
Identifier Type: -
Identifier Source: org_study_id