Dexmedetomidine Use for Sedation in Patients Submitted to Tracheal Surgery

NCT ID: NCT03723538

Last Updated: 2019-01-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 14 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2018-08-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Silvia Fiorelli

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

azienda ospedaliero universitaria Sant'Andrea

Roma, , Italy

Countries

Italy

Other Identifiers

DEX=!

Identifier Type: -

Identifier Source: org_study_id