Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01158820
Previous Study | Return to List | Next Study

Alternative Sedation During Bronchoscopy (DEX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01158820
Recruitment Status : Completed
First Posted : July 8, 2010
Results First Posted : October 31, 2018
Last Update Posted : February 26, 2019
Sponsor:
Collaborator:
Hospira, now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
University of Pennsylvania

Tracking Information
First Submitted Date  ICMJE June 25, 2010
First Posted Date  ICMJE July 8, 2010
Results First Submitted Date  ICMJE August 29, 2018
Results First Posted Date  ICMJE October 31, 2018
Last Update Posted Date February 26, 2019
Study Start Date  ICMJE June 2010
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 3, 2018)
  • Decreased Minute Ventilation [ Time Frame: During the bronchoscopy procedure only, 58.5 minutes average ]
    An initial baseline minute ventilation estimate was obtained via calibrated respiratory impedance plethysmography bands. Subsequent minute ventilation was normalized to this value. Values exceeding 100% were excluded from analysis, as these typically reflected a period of hyperpnea subsequent to relief of airway obstruction by chin lift or jaw thrust.
  • Total Fentanyl [ Time Frame: During the bronchoscopy procedure only, 58.5 minutes average ]
    Total fentanyl dose delivered during the procedure
  • Total Midazolam [ Time Frame: Duration of procedure ]
    Total midazolam delivered during procedure
Original Primary Outcome Measures  ICMJE
 (submitted: July 7, 2010)
  • Minute ventilation [ Time Frame: About 2-3 hours during the bronchoscopy procedure only ]
    This will be assessed by calibrated respiratory inductance plethysmography
  • Time to adequate sedation and procedure duration [ Time Frame: About 2-3 hours during the bronchoscopy procedure only ]
    Amount of time and duration of adequate sedation of the patient
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 3, 2018)
  • Desaturation (Cumulative) [ Time Frame: During the bronchoscopy procedure only, 58.5 minutes average ]
    Cumulative time below saturation of 90% - the total number of seconds that the pulse oximeter reported a saturation below 90%
  • Desaturation (Longest) [ Time Frame: During the bronchoscopy procedure only, 58.5 minutes average ]
    Longest time below saturation of 90% (the number of seconds elapsed between the start of a period in which the pulse oximeter saturation fell below 90% and the return above 90%)
  • Conversion to General Anesthesia [ Time Frame: During the bronchoscopy procedure only, 58.5 minutes average ]
    Patients in which the procedure could not be completed without conversion to general anesthesia
  • Patient Satisfaction [ Time Frame: After the bronchoscopy procedure only ]
    Satisfaction rated by 10 point Likert scale (0 = Totally dissatisfied, 10 = Totally satisfied)
  • Endoscopist Satisfaction [ Time Frame: After the bronchoscopy procedure only ]
    Satisfaction rated by 10 point Likert scale (0 = Totally dissatisfied, 10 = Totally satisfied)
Original Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2010)
  • Cardiopulmonary stability [ Time Frame: About 2-3 hours during the bronchoscopy procedure only ]
    assessed by heart rate and pulse oximetry
  • Patient compliance [ Time Frame: About 2-3 hours during the bronchoscopy procedure only ]
    assessed by the number of coughs per minute during the procedure
  • Fentanyl/midazolam/benadryl consumption [ Time Frame: About 2-3 hours during the bronchoscopy procedure only ]
    The measurement of the amount of the standard of care sedation medications will be used during the procedure.
  • Frequency of rescue from inadequate sedation [ Time Frame: About 2-3 hours during the bronchoscopy procedure only ]
    Measurement of time frame of inadequate sedation requiring intervention from the anesthesiologist.
  • Patient and endoscopist satisfaction [ Time Frame: About 2-3 hours during the bronchoscopy procedure only ]
    assessed by Likert scale
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Alternative Sedation During Bronchoscopy
Official Title  ICMJE A Randomized, Placebo-controlled, Concealed Allocation Comparison of Respiratory Depression and Coughing During Bronchoscopy With Dexmedetomidine-ketamine as an Adjunct to Fentanyl-midazolam Sedation
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Sedation
Intervention  ICMJE
  • Drug: Dexmedetomidine load
    Dexmedetomidine 1 µg/kg prior to bronchoscopy
    Other Names:
    • Precedex
    • Dexmedetomidine Hydrochloride
  • Drug: Ketamine load
    Ketamine 30 mg bolus prior to bronchoscopy
    Other Names:
    • Ketalar
    • Calypsol
    • Ketamin
    • Ketaminol
    • Ketanest
    • Tekam
    • Vetalar
  • Drug: Midazolam load
    2 mg bolus prior to bronchoscopy
    Other Name: Versed
  • Drug: Fentanyl load
    50 µg bolus prior to bronchoscopy
    Other Names:
    • Abstral
    • Actiq
    • Fentora
    • Onsolis
  • Drug: Dexmedetomidine maintenance
    0.5 µg/kg/hour for the duration of bronchoscopy (58.5 minutes average)
    Other Names:
    • Precedex
    • Dexmedetomidine Hydrochloride
  • Drug: Ketamine maintenance
    8 µg/kg/min for the duration of bronchoscopy (58.5 minutes average)
    Other Names:
    • Ketalar
    • Calypsol
    • Ketamin
    • Ketaminol
    • Ketanest
    • Tekam
    • Vetalar
  • Drug: Midazolam demand
    0.5 mg demand bolus at discretion of pulmonologist
    Other Name: Versed
  • Drug: Fentanyl demand
    12.5 µg demand bolus at discretion of pulmonologist
    Other Names:
    • Abstral
    • Actiq
    • Fentora
    • Onsolis
  • Drug: Benadryl demand
    25 mg bolus after 6th and 13th demand midazolam/fentanyl bolus
    Other Names:
    • Diphenhydramine Hcl
    • Aler-Dryl
    • Banophen
    • Ben Tann
    • Bromanate AF
    • Diphen
    • Diphenadryl
    • Diphenhist
    • Dytan
    • Unisom
    • Sominex
    • Silphen
    • Siladryl
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    midazolam load fentanyl load midazolam demand fentanyl demand benadryl demand
    Interventions:
    • Drug: Midazolam load
    • Drug: Fentanyl load
    • Drug: Midazolam demand
    • Drug: Fentanyl demand
    • Drug: Benadryl demand
  • Active Comparator: dexmedetomidine and ketamine
    dexmedetomidine load ketamine load dexmedetomidine maintenance ketamine maintenance midazolam demand fentanyl demand benadryl demand
    Interventions:
    • Drug: Dexmedetomidine load
    • Drug: Ketamine load
    • Drug: Dexmedetomidine maintenance
    • Drug: Ketamine maintenance
    • Drug: Midazolam demand
    • Drug: Fentanyl demand
    • Drug: Benadryl demand
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 7, 2010)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01158820
Other Study ID Numbers  ICMJE 810981
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Pennsylvania
Study Sponsor  ICMJE University of Pennsylvania
Collaborators  ICMJE Hospira, now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Principal Investigator: Jeff E Mandel, MD MS University of Pennsylvania
PRS Account University of Pennsylvania
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP