Dexmedetomidine Use for Sedation in Patients Submitted to Tracheal Surgery

Postoperative Sedation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03723538
• Other study ID #: DEX=!
• Status: Completed
• Start date: February 1, 2018
• Est. completion date: August 31, 2018

Study information

• Verified date: January 2019
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2018
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Postoperative Sedation

Intervention

Drug:
• Dexmedetomidine
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.

Locations

Country	Name	City	State
Italy	azienda ospedaliero universitaria Sant'Andrea	Roma

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)