Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05736198
Study type Observational
Source University of Illinois at Chicago
Contact Alexandra Barabanova, MS
Phone (312)355-5733
Email barabano@uic.edu
Status Not yet recruiting
Phase
Start date June 12, 2023
Completion date March 1, 2034

See also
  Status Clinical Trial Phase
Completed NCT05347121 - Difficult Airway and Ultrasonographic Evaluation
Completed NCT05519358 - Midsagittal Tongue Measurement to Predict Difficult Airways
Completed NCT01328405 - Air-Q Intubating Laryngeal Airway Versus the Laryngeal Mask Airway (LMA)-Proseal Phase 4
Completed NCT01100957 - Evaluation of the Single Use Flexible Optical Scope Versus Multiple Use Flexible Optical Scopes for Intubation N/A
Not yet recruiting NCT03125837 - Establishment of Airway Database for Surgical Patients N/A
Completed NCT01632683 - STorz Against Glidescope Effectiveness N/A
Completed NCT05327842 - Evaluation of a Flexible Videoscope Training Simulator N/A
Withdrawn NCT03313947 - Airway Ultrasound Prediction and Correlation N/A
Recruiting NCT06183060 - Study on the Decision Support System of Difficult Airway Evaluation
Completed NCT02979171 - Comparison in Difficult Airway Scenario Induced in Patients With Laryngeal Mask Airway (LMA)-Classic™, LMA™ - Flexible and LMA - Proseal™ Phase 4
Completed NCT02313168 - F.R.O.N.T. Formula for Pre-operative Airway Assessment and Documentation N/A
Completed NCT00500916 - Different Techniques for Insertion of the ProSeal Laryngeal Mask Airway in Patients With Difficult Airway N/A
Completed NCT05414214 - Thyromental Height Test Versus Sternomental Displacement in Elderly
Recruiting NCT04458220 - Research on Early Warning and Solution System of Difficult Airway in Perioperative Period Based on Artificial Intelligence
Recruiting NCT02811562 - Learning Curves of Intubation for Simulated Difficult Airway Scenarios by Manikin: Comparison of Combined Pentax Airwayscope-fiberoptic Bronchoscope and Fiberoptic Bronchoscope Alone N/A
Completed NCT04005950 - Comparison of a Conventional and a Realistic Self-modified Model
Active, not recruiting NCT01185535 - Effects of Topical Anesthesia With Pressure Nebulized 2% Lidocaine During Awake Intubation Phase 2/Phase 3
Recruiting NCT06000267 - Incidence and Contributing Anthropometric Factors of Difficult Airway in Pediatric Surgical Patients
Completed NCT03404453 - Difficult Airway Prediction in Paediatric Anaesthesia
Completed NCT01664234 - Oxygen Insuflation and ArterialDesaturation During Tracheal Intubation in Children N/A