Dexmedetomidine Use for Sedation in Patients Submitted to Tracheal Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy and Safety of Dexmedetomidine Sedation in Spontaneous Breathing Patients After Tracheal Surgery

Conditions
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Postoperative Sedation

Intervention / Treatment
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* Drug: Dexmedetomidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients submitted to tracheal surgery elective surgery age ≥ 18 years Exclusion Criteria: severe neurological disorder visual or hearing impairment acute cerebrovascular disease mean arterial pressure (MAP) <55 mmHg or hypotension requiring the use of inotropes/vasopressors heart rate (HR) <50 bpm second and third degree atrioventricular block (AV block) in the absence of PMK Sequential Organ Failure Assessment (SOFA) score <2 index hepatic failure emergency surgery pregnancy patient refusal to give consent inability to give consent age ≤18 years ASA score ≥ IV.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Dexmedetomidine|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | at T0 (baseline), 3, 6, 12 and 18 hours from the beginning of the infusion) |