Trials Sponsors Conditions Drugs Pricing

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

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.

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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

Sponsors & Collaborators

University of Roma La Sapienza
Otherlead

Study Sites (1)

azienda ospedaliero universitaria Sant'Andrea

Roma, Italy

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Enrollment

14 participants (actual enrollment reported by the registry).

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

Actual (reported)

Dexmedetomidine Use for Sedation in Patients Submitted to Tracheal Surgery

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations