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Completed

NCT Number: NCT03723538

Dexmedetomidine Use for Sedation in Patients Submitted to 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.

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Key information

Conditions

Postoperative Sedation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

azienda ospedaliero universitaria Sant'Andrea

Roma, Italy

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. The primary endpoint is the efficacy in changing the sedation level during the infusion

    Time frame: 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 outcomes

  1. The secondary endpoint is evaluation of safety throughout the incidence of adverse effects during the infusion

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Oct 29, 2018
Registry last updated
Jan 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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