Comparison of Two Sedation Regimens for Awake Fiberoptic Intubation

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Illinois at Chicago

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects with potentially difficult airways who require awake fiberoptic intubations will be identified from the OR schedule and the pre-operative clinic workups.

Disqualifiers

Anyone who does not meet the inclusion criteria

Trial population

All adults with potentially difficult airways undergoing elective procedures will be eligible.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Dexmedetomidine

    Drug

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

Treatment groups

96 Participants
are divided into 2 treatment groups
Group A: Dexmedetomidine1 intervention
Group B: Placebo0 interventions

Trial outcomes

Primary outcomes

1

Desaturation

Measurement using pulse oximetry (percent saturation)

Time frame
During intubation
2

Hemodynamic Lability

mm Hg

Time frame
During intubation
3

Dose of Fentanyl Used

mcg

Time frame
During intubation

Secondary outcomes

1

Patient overall experience assessed by VAS satisfaction.

Polling will be taken to measure patients' satisfaction with each sedation regiment on the scale from 1-10

Time frame
24 hours after the surgery

Other outcomes

Sponsors and contacts

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