Alternative Sedation During Bronchoscopy

Ketamine

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.

Intervention / Treatment

  • Dexmedetomidine load (DRUG)
    Dexmedetomidine 1 µg/kg prior to bronchoscopy
  • Ketamine load (DRUG)
    Ketamine 30 mg bolus prior to bronchoscopy
  • Midazolam load (DRUG)
    2 mg bolus prior to bronchoscopy
  • Fentanyl load (DRUG)
    50 µg bolus prior to bronchoscopy
  • Dexmedetomidine maintenance (DRUG)
    0.5 µg/kg/hour for the duration of bronchoscopy (58.5 minutes average)
  • Ketamine maintenance (DRUG)
    8 µg/kg/min for the duration of bronchoscopy (58.5 minutes average)
  • Midazolam demand (DRUG)
    0.5 mg demand bolus at discretion of pulmonologist
  • Fentanyl demand (DRUG)
    12.5 µg demand bolus at discretion of pulmonologist
  • Benadryl demand (DRUG)
    25 mg bolus after 6th and 13th demand midazolam/fentanyl bolus

Condition or Disease

  • Sedation

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 90 Years
    Enrollment: 50 (ACTUAL)
    Funded by: Other|Industry
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    TRIPLE:
    • Participant
    • Care Provider
    • Investigator

    Clinical Trial Dates

    Start date: Jun 01, 2010
    Primary Completion: May 01, 2012 ACTUAL
    Completion Date: May 01, 2012 ACTUAL
    Study First Posted: Jul 08, 2010 ESTIMATED
    Results First Posted: Oct 31, 2018 ACTUAL
    Last Updated: Feb 05, 2019

    Sponsors / Collaborators

    Lead Sponsor: University of Pennsylvania
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    Philadelphia, Pennsylvania, USA

    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.

    Participant Groups

    • midazolam load fentanyl load midazolam demand fentanyl demand benadryl demand

    • dexmedetomidine load ketamine load dexmedetomidine maintenance ketamine maintenance midazolam demand fentanyl demand benadryl demand

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 90
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    • 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 dose delivered during the procedure

    • Total midazolam delivered during procedure

    Secondary Outcomes

    • Cumulative time below saturation of 90% - the total number of seconds that the pulse oximeter reported a saturation below 90%

    • 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%)

    • Patients in which the procedure could not be completed without conversion to general anesthesia

    • Satisfaction rated by 10 point Likert scale (0 = Totally dissatisfied, 10 = Totally satisfied)

    • Satisfaction rated by 10 point Likert scale (0 = Totally dissatisfied, 10 = Totally satisfied)

    More Details

    NCT Number: NCT01158820
    Acronym: DEX
    Other IDs: 810981
    Study URL: https://clinicaltrials.gov/study/NCT01158820
    Last updated: Sep 29, 2023