Dexmedetomidine vs. Remifentanil for Sedation During AFI
Completed · Phase 4
Conditions studied: Intubation, Endotracheal
In brief
The objective of this study is to determine the efficacy and safety of Dexmedetomidine, a selective alpha-2 adrenoceptor agonist, which has recently gained increased popularity for ICU and intraoperative sedation as a sedative during awake fiberoptic intubation, as compared to Remifentanil. The hypothesis is that Dexmedetomidine will provide at least equal if not better conditions (sedation and analgesia) required for awake fiberoptic intubation (Ramsay Sedation Scale 3) with less respiratory and cardiovascular adverse effects, as well as less recall than Remifentanil.
Key facts
- Study ID
- NCT00349245
- Run by
- The University of Texas Health Science Center, Houston
- People needed
- 30
- Starts
- 2006-06-01
- Expected to finish
- 2007-08-01
- Last updated by the study team
- 2016-03-23
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- A signed informed consent must be obtained after the nature of the study has been fully explained.
- Patients undergoing any procedure requiring general anesthesia with an endotracheal tube.
- Patients that have been assessed by an attending anesthesiologist to have an airway requiring awake fiberoptic intubation.
- Adult patients > 18 yrs. old, ASA I - III.
You may not qualify if…
- Patients expected to have severe adverse side effects to Dexmedetomidine including:
- Previous allergy to the drug.
- 3rd degree AV Block
- Hypovolemic hypotension
- Systemic vasoconstriction
- Patients expected to have a severe adverse side effect to Remifentanil. This includes:
- Previous allergy to the drug.
- Patients suspected of being overly sensitive to narcotics.
- Patients with significant cardiovascular disease or ASA physical status IV and V
Where it is running
- Memorial Hermann Hospital — Houston, Texas, United States
Full record on ClinicalTrials.gov
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