Comparison of Two Sedation Regimens for Awake Fiberoptic Intubation

Conditions

• Awake Fiberoptic Intubation
• Difficult Airway

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Dexmedetomidine — DRUG
  dexmedetomidine, midazolam, and fentanyl (titrated to effect) to facilitate intubation

Study Details

The purpose of this study is to examine the effects of different sedation drugs used for the awake fiberoptic intubation procedure. Benzodiazapines and narcotics (such as midazolam and fentanyl) are standard drugs used for sedation during awake fiberoptic intubation. Dexmedetomidine, midazolam, and fentanyl are approved by the Food and Drug Administration (FDA) procedural sedation. These drugs might be given to the patient regardless of their participation in the study. 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.

Key Dates

Start date

Aug 12, 2024

Status verified

Nov 2024

Primary completion

Jun 15, 2033

Completion

Mar 1, 2034

Study Design

Enrollment

96 participants (estimated)

Arms

• Arm: Dexmedetomidine
  Dexmedetomidine, midazolam, and fentanyl (titrated to effect) to facilitate intubation
• Arm: Placebo
  Normal Saline, midazolam, and fentanyl (titrated to effect) to facilitate the intubation

Primary Outcome Measure

Desaturation [ Time Frame: During intubation ]

Central Contacts

• Alexandra Barabanova, MS
  (312)355-5733
  [email protected]

Locations (1)

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