An observational study in Postoperative Sedation, sponsored by University of Roma La Sapienza. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-11.
Sponsored by University of Roma La Sapienza · Observational
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.
University of Roma La Sapienza is the lead sponsor of 388 studies on the registry; 55 are open to participants now.
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patients scheduled for elective tracheal resection and reconstruction surgery and admitted to ICU after surgery
Exclusion Criteria:
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.
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 .
Time frame: at T0 (baseline) and 12 hours from the beginning of the infusion
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
Time frame: at T0 (baseline), 3, 6, 12 and 18 hours from the beginning of the infusion)
Plan to share: No
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This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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University of Roma La Sapienza