We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Remifentanil Plus Ketamine for Dynamic Flexible Bronchoscopy

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: NCT03613792
Recruitment Status : Unknown
Verified January 2020 by Satya Krishna Ramachandran, Beth Israel Deaconess Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : August 3, 2018
Last Update Posted : January 14, 2020
Sponsor:
Information provided by (Responsible Party):
Satya Krishna Ramachandran, Beth Israel Deaconess Medical Center

Tracking Information
First Submitted Date  ICMJE July 30, 2018
First Posted Date  ICMJE August 3, 2018
Last Update Posted Date January 14, 2020
Estimated Study Start Date  ICMJE September 1, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 2, 2018)
Patient Satisfaction with Sedation Instrument (PSSI) [ Time Frame: Two hours after procedure conclusion, prior to patient discharge from the hospital ]
The primary outcome will be a difference in patient satisfaction with sedation, as determined by a 5-point difference in the PSSI questionnaire. The total score will be assessed by summing the responses to each question. In the scale, 0 will denote no satisfaction (worst outcome) and 100 will represent the greatest possible satisfaction (best outcome).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 2, 2018)
  • Numerical Rating Scale (NRS) for Discomfort [ Time Frame: Two hours after procedure conclusion, prior to patient discharge from the hospital ]
    Difference between both groups in terms of numerical rating scale (NRS) for discomfort associated with the procedure (as reported by the patient). In the scale, 0 will denote no discomfort (best outcome) and 5 will represent the greatest possible discomfort (worse outcome).
  • ALDRETE score [ Time Frame: Two hours after procedure conclusion, prior to patient discharge from the hospital ]
    The ALDRETE score (global assessment of post-anesthetic condition) is used to assess patients' recovery after bronchoscopy at PACU
  • Clinician Satisfaction with Sedation Instrument (CSSI) [ Time Frame: Two hours after procedure conclusion, prior to patient discharge from the hospital ]
    The total score will be assessed by summing the responses to each question. In the scale, 0 will denote no satisfaction (worst outcome) and 100 will represent the greatest possible satisfaction (best outcome).
  • Severity of Cough [ Time Frame: Two hours after procedure conclusion, prior to patient discharge from the hospital ]
    A scale to address severity of cough during the procedure will be used when the bronchoscope pass through the vocal cords and at the level of the proximal trachea, distal trachea and main bronchi. This scale has three categories: Mild, single coughs; Moderate, more than one episode of cough that last less than 5 seconds; and Severe, cough more than 5 seconds
  • Incidence of Complications [ Time Frame: Two hours after procedure conclusion, prior to patient discharge from the hospital ]
    Complications such as desaturation, hypotension, pain, nausea, bradycardia, need for artificial airway or mechanical ventilation and need to abort bronchoscopy will be documented. These will then be compared as percentage of complications.
  • Duration of Dynamic Flexible Bronchoscopy [ Time Frame: Two hours after procedure conclusion, prior to patient discharge from the hospital ]
    Defined as the total time spent between initial insertion of flexible bronchoscope and final withdrawal of such.
  • PACU Length of Stay [ Time Frame: Until discharge from the PACU, on average one hour ]
    Total time of PACU stay with each of the pharmacological combinations, defined as the period of time between initial PACU arrival and final home or floor discharge.
  • Total Nebulized Lidocaine Dose [ Time Frame: Until discharge from the PACU, on average one hour ]
    Total dose requirement of nebulized lidocaine, pain medication and cough suppressors at PACU discharge.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Remifentanil Plus Ketamine for Dynamic Flexible Bronchoscopy
Official Title  ICMJE Remifentanil Plus Ketamine Versus Midazolam Plus Fentanyl for Dynamic Flexible Bronchoscopy: Randomized Double-blind Clinical Trial
Brief Summary This randomized controlled pilot clinical trial will enroll patients undergoing dynamic flexible bronchoscopy will be randomized to receive one of the two anesthetic combinations described above. The study will determine if there is a difference when considering patient and physician and satisfaction when performing DFB. Also, safety and efficacy of the two pharmacological combinations (fentanyl + midazolam and remifentanil + ketamine) used will be evaluated.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
Condition  ICMJE Bronchoscopy
Intervention  ICMJE
  • Drug: Remifentanil
    Opioid analgesic
  • Drug: Fentanyl
    Opioid analgesic
  • Drug: Midazolam
    Benzodiazepine
    Other Name: Versed
  • Drug: Ketamine
    Analgesic
Study Arms  ICMJE
  • Active Comparator: Remifentanil and Ketamine Group
    Patients in Group 1 will receive remifentanil and ketamine. Remifentanil will be administered initially with a 1mcg/kg IV bolus followed by a continuous infusion, 0.1 to 0.15 mcg/kg/min IV (using ideal body weight) with titration to a maximum dose of 0.2 to 0.4 mcg/kg/min IV. Total dose of ketamine will be titrated from 10 to 40 mg, based on clinical judgment, and it will be recorded. Ketamine will be delivered using 2mL syringes, previously filled with ketamine in normal saline at a 10mg/mL concentration.
    Interventions:
    • Drug: Remifentanil
    • Drug: Ketamine
  • Active Comparator: Fentanyl and Midazolam
    The patients in this group will receive fentanyl doses that range between 0.5 to 2 mcg/kg (25 - 50 mcg) IV bolus in combination with midazolam 1-5 mg bolus over at least 2 minutes as determined by attending anesthesiologist (not to exceed 2.5 mg / 2 min per package insert). Total dosing of fentanyl and midazolam may be titrated, based on clinical judgment, and it will be recorded. Maintenance, additional midazolam doses of 25% of total initial dose required to achieved desired sedation may be administered IV if additional sedation is considered necessary
    Interventions:
    • Drug: Fentanyl
    • Drug: Midazolam
Publications * Not Provided

*   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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 2, 2018)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  • Adult (>18 years-old)
  • Undergoing planned flexible bronchoscopy with dynamic maneuvers for Excessive Central Airway Collapse assessment at Beth Israel Deaconess Medical Center.

Exclusion criteria:

  • Patients with any past medical history of disease that would put them at risk of receiving one of the four proposed medications. This includes, but it's not limited to, allergies, advanced stage kidney disease, congestive heart failure and non-controlled hypertension.
  • With a known/documented history of opioid abuse at any point during life.
  • PO2< 60 mmHg or SO2 <85% on room air during any of the encounters with physicians between the moment of initial screening and the procedure itself.
  • PaCO2 >60 mmHg
  • Planned additional procedure(s) requiring general anesthesia after the dynamic bronchoscopy.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (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 NCT03613792
Other Study ID Numbers  ICMJE 2018P000023
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Satya Krishna Ramachandran, Beth Israel Deaconess Medical Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Beth Israel Deaconess Medical Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Satya Krishna Ramachandran, MD Beth Israel Deaconess Medical Center
PRS Account Beth Israel Deaconess Medical Center
Verification Date January 2020

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