Recruiting

Dexmedetomidine

Sponsor:

University of Illinois at Chicago

Code:

NCT05736198

Conditions

Awake Fiberoptic Intubation

Difficult Airway

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dexmedetomidine

Study Details

Brief 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.

Conditions

Awake Fiberoptic Intubation

Difficult Airway

Study ID

NCT05736198

Start date

Aug 12, 2024

Status verified date

Nov, 2024

Completion date

Mar 1, 2034

Anticipated

Primary completion date

Jun 15, 2033

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

96 participants

Anticipated

Interventions and Outcome Measures

Arms

Dexmedetomidine

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

Placebo

Normal Saline, midazolam, and fentanyl (titrated to effect) to facilitate the intubation

Interventions

Dexmedetomidine

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

Primary outcome measure

  • Desaturation [ Time Frame: During intubation ]
  • Hemodynamic Lability [ Time Frame: During intubation ]
  • Dose of Fentanyl Used [ Time Frame: During intubation ]

Central Contacts and Locations

Central contacts

Alexandra Barabanova, MS

(312)355-5733barabano@uic.edu

Locations

University of Illinois

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Alexandra Barabanova, MS

312-355-5733

More Information

Sponsor

University of Illinois at Chicago

Last update posted

Nov 29, 2024

Last verified

Nov, 2024

Keywords

  • Dexmedetomidine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Illinois at Chicago on 2024-11-29.