Dexmedetomidine Use for Sedation in Patients Submitted to Tracheal Surgery

Completed

• Conditions: Postoperative Sedation

• Registration Number: NCT03723538
• Lead Sponsor: University of Roma La Sapienza

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-01
• Primary Completion: 2018-08-31
• Study Completion: 2018-08-31
• Study First Submitted: 2018-10-18
• Study First Submitted QC: 2018-10-25
• Study First Posted: 2018-10-29
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-10
• Last Update Posted: 2019-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• patients submitted to tracheal surgery
• elective surgery
• age ≥ 18 years

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

azienda ospedaliero universitaria Sant'Andrea; 🇮🇹 Roma, Italy