Alternative Sedation During Bronchoscopy



Status:Completed
Conditions:Hospital, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases, Other
Healthy:No
Age Range:18 - 90
Updated:2/28/2019
Start Date:June 2010
End Date:May 2012

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A Randomized, Placebo-controlled, Concealed Allocation Comparison of Respiratory Depression and Coughing During Bronchoscopy With Dexmedetomidine-ketamine as an Adjunct to Fentanyl-midazolam Sedation

This protocol hopes to determine whether the use of dexmedetomidine-ketamine can reduce the
use of standard of care fentanyl-midazolam sedation during bronchoscopy. This may result in
less respiratory depression while providing better compliance with the procedure.

All patients enrolled in the study will be undergoing bronchoscopy, which is typically
performed with sedation. All procedural sedation carries some risk. Several features of the
study may lower the risk of sedation relative to that of conventional sedation. An
anesthesiologist will be present throughout the procedure. Continuous monitoring of
respiration with RIP will be employed. Administration of sedation will be via a volumetric
syringe pump. Benefits specific to dexmedetomidine-ketamine include the lack of respiratory
depression and greater hemodynamic stability.

Inclusion Criteria:

- Adults over the age of 18 scheduled for elective flexible bronchoscopy in the
endoscopy suite or OR of HUP

Exclusion Criteria:

- History of inability to complete bronchoscopy attributable to inadequate sedation

- Requiring more than 2 LPM supplemental oxygen to maintain SaO2 > 90%

- History of allergy to study medications

- Pregnancy

- A history of psychosis

- Any condition deemed likely by the pulmonologist or anesthesiologist to pose a
significant risk due to elevation of blood pressure, including cerebral/aortic
aneurysm, and or ischemic cardiovascular disease

- Bradydysrhythmia deemed significant by the anesthesiologist or pulmonologist

- A diagnosis of significant renal or hepatic impairment
We found this trial at
1
site
3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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