Dexmedetomidine Use for Sedation in Patients Submitted to Tracheal Surgery

University of Roma La Sapienza14 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Postoperative Sedation

Interventions

DexmedetomidineDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

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)