Clinical trial NCT01158820: Alternative Sedation During Bronchoscopy
Official title: A Randomized, Placebo-controlled, Concealed Allocation Comparison of Respiratory Depression and Coughing During Bronchoscopy With Dexmedetomidine-ketamine as an Adjunct to Fentanyl-midazolam Sedation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sedation
Keywords: bronchoscopy
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Hospira, now a wholly owned subsidiary of Pfizer
First posted: 2010-07-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Decreased Minute Ventilation
timeFrame: During the bronchoscopy procedure only, 58.5 minutes average
measure: Total Fentanyl
timeFrame: During the bronchoscopy procedure only, 58.5 minutes average
measure: Total Midazolam
timeFrame: Duration of procedure
Secondary outcomes:
measure: Desaturation (Cumulative)
timeFrame: During the bronchoscopy procedure only, 58.5 minutes average
measure: Desaturation (Longest)
timeFrame: During the bronchoscopy procedure only, 58.5 minutes average
measure: Conversion to General Anesthesia
timeFrame: During the bronchoscopy procedure only, 58.5 minutes average
measure: Patient Satisfaction
timeFrame: After the bronchoscopy procedure only
measure: Endoscopist Satisfaction
timeFrame: After the bronchoscopy procedure only
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Jeff E Mandel, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yarmus LB, Akulian JA, Gilbert C, Mathai SC, Sathiyamoorthy S, Sahetya S, Harris K, Gillespie C, Haas A, Feller-Kopman D, Sterman D, Lee HJ. Comparison of moderate versus deep sedation for endobronchial ultrasound transbronchial needle aspiration. Ann Am Thorac Soc. 2013 Apr;10(2):121-6. doi: 10.1513/AnnalsATS.201209-074OC.