Comparison of Two Sedation Regimens for Awake Fiberoptic Intubation

NCT05736198 | Recruiting FDA Drug

• 1 other identifier: 2023-0181
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 1

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

Keywords

Dexmedetomidine

Outcome Measures

Primary Outcomes (3)

• Desaturation

  Measurement using pulse oximetry (percent saturation)

  During intubation

• Hemodynamic Lability

  mm Hg

  During intubation

• Dose of Fentanyl Used

  mcg

  During intubation

Secondary Outcomes (1)

• Patient overall experience assessed by VAS satisfaction.

  24 hours after the surgery

Study Arms (2)

Dexmedetomidine

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

Drug: Dexmedetomidine

Placebo

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

Interventions

Dexmedetomidine DRUG

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

Also known as: Precedex

Dexmedetomidine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois

Chicago, Illinois, 60612, United States

RECRUITING

Related Publications (1)

• Scher CS, Gitlin MC. Dexmedetomidine and low-dose ketamine provide adequate sedation for awake fibreoptic intubation. Can J Anaesth. 2003 Jun-Jul;50(6):607-10. doi: 10.1007/BF03018650.

  PMID: 12826556 BACKGROUND

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• David Glick, MD

  Department of Anesthesiology Head

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandra Barabanova, MS

CONTACT

(312)355-5733; barabano@uic.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Anesthesiology Head

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: February 21, 2023
• Study Start: August 12, 2024
• Primary Completion (Estimated): June 15, 2033
• Study Completion (Estimated): March 1, 2034
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)