Dexmedetomidine Use for Sedation in Patients Submitted to Tracheal Surgery

Efficacy and Safety of Dexmedetomidine Sedation in Spontaneous Breathing Patients After Tracheal Surgery

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 Overview

• Status: Completed
• Conditions: Postoperative Sedation
• Intervention / Treatment: Drug: Dexmedetomidine

• Study Type: Observational
• Enrollment (Actual): 14

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy
    • Azienda Ospedaliero Universitaria Sant'Andrea

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): August 31, 2018
• Study Completion (Actual): August 31, 2018

Study Registration Dates

• First Submitted: October 18, 2018
• First Submitted That Met QC Criteria: October 25, 2018
• First Posted (Actual): October 29, 2018

Study Record Updates

• Last Update Posted (Actual): January 11, 2019
• Last Update Submitted That Met QC Criteria: January 10, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: DEX=!

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No