Safety and Efficacy of Intravenous (IV) Dexmedetomidine During Flexible Bronchoscopy and Endobronchial Ultrasound
This study has been withdrawn prior to enrollment.
(PI left institution prior to enrollment)
Sponsor:
Lahey Clinic
Information provided by (Responsible Party):
Lahey Clinic
ClinicalTrials.gov Identifier:
NCT00691886
First received: June 4, 2008
Last updated: May 9, 2012
Last verified: May 2012
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Purpose
To achieve safe,consistent, continuous sedation using Dexmedetomidine in advaced bronchoscopy procedures that may reduce the need for rapid pain sedative infusion.
| Condition | Intervention | Phase |
|---|---|---|
|
Pain |
Drug: dexmedetomidine hydrochloride |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Safety and Efficacy of Intravenous Dexmedetomidine Infusion During Flexible Bronchoscoy and Endobronchical Ultrasound |
Resource links provided by NLM:
Further study details as provided by Lahey Clinic:
Primary Outcome Measures:
- Achieve safe, consistent, continous moderate sedation using Dexmedetomidine in advanced bronchoscopy procedures, alleviating the need for rapid sedative infusion. [ Time Frame: at conclusion of subject enrollemtn ] [ Designated as safety issue: Yes ]
| Enrollment: | 0 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: 1
Subjects randomized to arm 1 of the study will recieve standard of care conscious sedation for EBUS; midasolam and or fentanyl.
|
|
|
Active Comparator: 2
Subjects undergoing EBUS randomized to arm 2 of the study will recieve demedetomadine hydrochloride plus standard of care conscious sedation
|
Drug: dexmedetomidine 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.
Other Name: Precedex
|
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
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00691886
Locations
| United States, Massachusetts | |
| Lahey Clinic | |
| Burlington, Massachusetts, United States, 01805 | |
Sponsors and Collaborators
Lahey Clinic
Investigators
| Principal Investigator: | David R Riker, MD | Lahey Clinic Medical Center |
More Information
No publications provided
| Responsible Party: | Lahey Clinic |
| ClinicalTrials.gov Identifier: | NCT00691886 History of Changes |
| Other Study ID Numbers: | 2008-011 |
| Study First Received: | June 4, 2008 |
| Last Updated: | May 9, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Lahey Clinic:
|
sedation |
Additional relevant MeSH terms:
|
Dexmedetomidine Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Analgesics, Non-Narcotic Analgesics |
Sensory System Agents Peripheral Nervous System Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013