Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05736198

Comparison of Two Sedation Regimens for Awake Fiberoptic Intubation

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Awake Fiberoptic Intubation Difficult Airway

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Illinois

Chicago, Illinois, 60612, United States

Location status: Recruiting

Location contact

Alexandra Barabanova, MS

CONTACT

312-355-5733

About this study

This is an observational study designed to evaluate effectiveness of two standard of care protocols used for patients with potentially difficult airway during awake fiberoptic intubation.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Anyone who does not meet the inclusion criteria

Treatment and study plan

Dexmedetomidine

Drug

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

Other names: Precedex

Primary outcomes

  1. Desaturation

    Time frame: During intubation

    Measurement using pulse oximetry (percent saturation)

  2. Hemodynamic Lability

    Time frame: During intubation

    mm Hg

  3. Dose of Fentanyl Used

    Time frame: During intubation

    mcg

Secondary outcomes

  1. Patient overall experience assessed by VAS satisfaction.

    Time frame: 24 hours after the surgery

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

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandra Barabanova, MS

CONTACT

[email protected]

(312)355-5733

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Registry information

Important dates

Study start
2024
Primary completion
2033
Study completion
2034
First posted
Feb 21, 2023
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.