Safety and Efficacy of Intravenous (IV) Dexmedetomidine During Flexible Bronchoscopy and Endobronchial Ultrasound

Safety and Efficacy of Intravenous Dexmedetomidine Infusion During Flexible Bronchoscoy and Endobronchical Ultrasound

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00691886

Enrollment

Registered

2008-06-06

Start date

2008-04-30

Completion date

2012-07-31

Last updated

2012-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

sedation

Brief summary

To achieve safe,consistent, continuous sedation using Dexmedetomidine in advaced bronchoscopy procedures that may reduce the need for rapid pain sedative infusion.

Detailed description

Dexmedetomidine hydrochloride as a single agent produces sedation, pain relief, anxiety redution, stable respiratory rates, and predictable cardiovascular responses. Dexmedetomidine facilitates patient comfort, compliance and comprehension by offering sedation with the ability to awaken patients. This study is being done to determine sedation efficacy and dosing; measure reduction or eliminate the need for rapid sedative infusion during bronchoscopy; improvement of patient comfort and safety during complex bronchoscopy; establish a new paradigm for moderate sedation during flexible bronchoscopy

Interventions

DRUGdexmedetomidine hydrochloride

Dose of 0.4ug/kg/hr to 1.5ug/kg/hr to achieve a RASS score of -1 to-3 during the bronchoscopy procedure. Dexmedetomidine will infused a half hour before the proceudure is started and will continue throughout the procedure. Traditional sedatives (midazolam and or fentanyl) will be given prn.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

* Adults between the age of 18 and 85 * Adults scheduled for flexible brochoscopy using EUBS (Endobronchial Ultrasound)

Exclusion criteria

* Sever bradycardia (rate \< 50) and / or related bradydysrhymias (e.g. advanced heart block) * Impaired ventricular functions (EF \<30%) * Hypovolemia or hypotension (SBP \<90 or MAP \<a55) * Have GFR less than 15ml/min 1.73m2 or undergoing hemodialysis * Endstage liver disease.

Design outcomes

Primary

Measure	Time frame
Achieve safe, consistent, continous moderate sedation using Dexmedetomidine in advanced bronchoscopy procedures, alleviating the need for rapid sedative infusion.	at conclusion of subject enrollemtn

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026