Comparison of Two Sedation Regimens for Awake Fiberoptic Intubation

Difficult Airway Clinical Trial

Official title:

Comparison of Two Sedation Regimens for Awake Fiberoptic Intubation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05736198
• Other study ID #: 2023-0181
• Status: Not yet recruiting
• Start date: June 12, 2023
• Est. completion date: March 1, 2034

Study information

• Verified date: May 2023
• Source: University of Illinois at Chicago
• Contact: Alexandra Barabanova, MS
• Phone: (312)355-5733
• Email: barabano[@]uic.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 96
• Est. completion date: March 1, 2034
• Est. primary completion date: June 15, 2033
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Awake Fiberoptic Intubation
• Difficult Airway

Intervention

Drug:
• Dexmedetomidine
dexmedetomidine, midazolam, and fentanyl (titrated to effect) to facilitate intubation

Locations

Country	Name	City	State
United States	University of Illinois	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Desaturation	Measurement using pulse oximetry (percent saturation)	During intubation
Primary	Hemodynamic Lability	mm Hg	During intubation
Primary	Dose of Fentanyl Used	mcg	During intubation
Secondary	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	24 hours after the surgery