Postoperative Sedation
Conditions
Brief summary
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.
Interventions
DRUGDexmedetomidine
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.
Sponsors
University of Roma La Sapienza
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary endpoint is the efficacy in changing the sedation level during the infusion | at T0 (baseline) and 12 hours from the beginning of 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 . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The secondary endpoint is evaluation of safety throughout the incidence of adverse effects during the infusion | at T0 (baseline), 3, 6, 12 and 18 hours from the beginning of 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 |
Countries
Italy
Outcome results
None listed