Dexmedetomidine Use for Sedation in Patients Submitted to Tracheal Surgery

NCT03723538 | Completed FDA Drug

• 1 other identifier: DEX=!
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Sedation

Outcome Measures

Primary Outcomes (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 .

  at T0 (baseline) and 12 hours from the beginning of the infusion

Secondary Outcomes (1)

• 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)

Interventions

Dexmedetomidine DRUG

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 Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients scheduled for elective tracheal resection and reconstruction surgery and admitted to ICU after surgery

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

azienda ospedaliero universitaria Sant'Andrea

Roma, Italy

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: October 18, 2018
• First Posted: October 29, 2018
• Study Start: February 1, 2018
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: January 11, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)