Postoperative Sedation Clinical Trial
Official title:
Efficacy and Safety of Dexmedetomidine Sedation in Spontaneous Breathing Patients After Tracheal Surgery
NCT number | NCT03723538 |
Other study ID # | DEX=! |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 1, 2018 |
Est. completion date | August 31, 2018 |
Verified date | January 2019 |
Source | University of Roma La Sapienza |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | 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.
Status | Completed |
Enrollment | 14 |
Est. completion date | August 31, 2018 |
Est. primary completion date | August 31, 2018 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Italy | azienda ospedaliero universitaria Sant'Andrea | Roma |
Lead Sponsor | Collaborator |
---|---|
University of Roma La Sapienza |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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) |
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