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Patients undergoing tracheal resection and reconstruction surgery are enrolled in this prospective observational pilot study to evaluate dexmedetomidine-based sedation after tracheal surgery in an Intensive Care Unit (ICU). Patients remain electively intubated with an uncuffed nasal endotracheal tube, awake and exhibit spontaneous breathing The neck was maintained in flexion through chin-to-chest sutures. Infusion of dexmedetomidine was started from a dosage of 0.7 μg kg-1 h-1 followed by dose titration to the target level of the sedation Richmond Agitation Sedation Scale, (RASS) score -1/-2 using a dose range of 0.2-1.4 μg kg-1 h-1.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | patients undergoing tracheal resection and reconstruction surgery were enrolled in this prospective observational pilot study to evaluate dexmedetomidine-based sedation after tracheal surgery in an Intensive Care Unit (ICU). Patients remain electively intubated with an uncuffed nasal endotracheal tube, awake and exhibit spontaneous breathing The neck was maintained in flexion through chin-to-chest sutures. Infusion of dexmedetomidine was started from a dosage of 0.7 μg kg-1 h-1 followed by dose titration to the target level of the sedation Richmond Agitation Sedation Scale, (RASS) score -1/-2 using a dose range of 0.2-1.4 μg kg-1 h-1. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint is the efficacy in changing the sedation level during the infusion | monitored through the sedation scale called Richmond Agitation-Sedation Scale(RASS).RASS is a medical scale used to measure the agitation or sedation level of a person.The score ranges from +4 "combative" to -5 "unarousable". The target level of the sedation is a RASS score -1/-2 . | at T0 (baseline) and 12 hours from the beginning of the infusion |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary endpoint is evaluation of safety throughout the incidence of adverse effects during the infusion | by recording modification of MAP, HR, and SpO2. Any cardiorespiratory complications (hypotension with MAP<60 mmHg or 50% baseline reduction, bradycardia with HR <40 bpm or reduction of greater than 50% of the baseline value, and desaturation with SpO2 <90%) were also recorded.pain control assessed by VAS, need of rescue doses of alternative drugs |
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Inclusion Criteria:
Exclusion Criteria:
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patients scheduled for elective tracheal resection and reconstruction surgery and admitted to ICU after surgery
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| azienda ospedaliero universitaria Sant'Andrea | Roma | Italy |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| at T0 (baseline), 3, 6, 12 and 18 hours from the beginning of the infusion) |