Dexmedetomidine and low-dose ketamine provide adequate sedation for awake fibreoptic intubation.
Corey S Scher, Melvin C Gitlin
https://pubmed.ncbi.nlm.nih.gov/12826556Actively Recruiting
Age: 18Years +
All Genders
ID05736198
Comparison of Two Sedation Regimens for Awake Fiberoptic Intubation
Led by University of Illinois at Chicago · Updated on 2024-11-29
96
Participants Needed
1
Research Sites
37 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of different sedation drugs used during awake fiberoptic intubation, a procedure for patients with potentially difficult airways. This observational study compares two sedation protocols involving drugs approved by the FDA for procedural sedation, including midazolam, fentanyl, and either dexmedetomidine or a placebo. The study aims to determine if dexmedetomidine better maintains breathing compared to the standard combination of drugs. Participants will be randomly assigned to one of two groups: one receiving dexmedetomidine along with midazolam and fentanyl, and the other receiving a placebo with midazolam and fentanyl. Both groups will also receive lidocaine applied directly or via transtracheal injection to reduce irritation during intubation. Doses of dexmedetomidine will follow recommended guidelines between 0.3 and 0.7 mcg/kg/hour. Standard airway precautions and alternative devices will be available for patient safety. During the procedure, researchers will record oxygen levels, heart and blood pressure stability, and the amount of fentanyl used. Patient discomfort, gagging, and satisfaction with the intubation will also be assessed, including a brief survey 24 hours after surgery. Medical records and observations by anesthesiologists and research staff will provide data to evaluate sedation effectiveness and patient experience throughout the study.
CONDITIONS
Brief Title
Comparison of Two Sedation Regimens for Awake Fiberoptic Intubation
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Subjects with potentially difficult airways who require awake fiberoptic intubations will be identified from the OR schedule and the pre-operative clinic workups.
You will not qualify if you...
- Anyone who does not meet the inclusion criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Duration of intubation procedure
Participants receive one of two sedation regimens (either dexmedetomidine, midazolam, and fentanyl or placebo, midazolam, and fentanyl) during awake fiberoptic intubation with topical lidocaine application to facilitate the procedure.
1 procedural visit (in-person)
Follow-up
Duration - 24 hours after surgery
Participants complete a brief 5-minute survey to assess satisfaction with the intubation procedure approximately 24 hours after surgery.
1 follow-up visit (remote or in-person)
Trial Site Locations
Total: 1 location
1
University of Illinois
Chicago, Illinois, United States, 60612
Actively Recruiting
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Research Team
A
Alexandra Barabanova, MS
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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