RecruitingNCT05736198

Comparison of Two Sedation Regimens for Awake Fiberoptic Intubation


Sponsor

University of Illinois at Chicago

Enrollment

96 participants

Start Date

Aug 12, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two different sedation methods used when patients need to be awake during a breathing tube placement — a procedure known as awake fiberoptic intubation (AFOI). This technique is used when a patient's airway is expected to be difficult to manage under general anesthesia, requiring the tube to be placed while they are conscious but comfortable. The study tests whether a new sedation drug combination works as well as or better than the current standard approach in keeping patients calm and cooperative while maintaining their ability to breathe. Adults aged 18 and older who have been identified as having a potentially difficult airway and are scheduled for awake fiberoptic intubation are eligible. The identification of eligible patients happens through the surgical schedule and pre-operative assessments by anesthesia teams. Participants receive one of the two sedation regimens before and during the procedure. Both approaches are already in clinical use; the study simply compares their outcomes in terms of patient comfort, safety, and procedure success rates. This research matters because awake intubation can be a stressful and uncomfortable experience. Finding the best sedation approach can improve patient safety and experience, especially in high-risk airway situations where maintaining the patient's protective reflexes is critical.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDexmedetomidine

dexmedetomidine, midazolam, and fentanyl (titrated to effect) to facilitate intubation


Locations(1)

University of Illinois

Chicago, Illinois, United States

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NCT05736198


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