Remifentanil Plus Ketamine for Dynamic Flexible Bronchoscopy

Ketamine

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.

Intervention / Treatment

  • Remifentanil (DRUG)
    Opioid analgesic
  • Fentanyl (DRUG)
    Opioid analgesic
  • Midazolam (DRUG)
    Benzodiazepine
  • Ketamine (DRUG)
    Analgesic

Condition or Disease

  • Bronchoscopy

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Withdrawn
    Study results: No Results Available
    Age: 19 Years and older   (Adult, Older Adult)
    Enrollment: 0 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Supportive Care

    Masking

    DOUBLE:
    • Participant
    • Care Provider

    Clinical Trial Dates

    Start date: Sep 01, 2023 ESTIMATED
    Primary Completion: Dec 01, 2023 ESTIMATED
    Completion Date: Dec 01, 2023 ESTIMATED
    Study First Posted: Aug 03, 2018 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Jul 25, 2023

    Sponsors / Collaborators

    Lead Sponsor: Beth Israel Deaconess Medical Center
    Responsible Party: N/A

    Location

    Boston, Massachusetts, USA

    Participant Groups

    • 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.

    • 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

    Eligibility Criteria

    Sex: All
    Minimum Age: 19
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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.

    Primary Outcomes

    • 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).

    Secondary Outcomes

    • 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).

    • The ALDRETE score (global assessment of post-anesthetic condition) is used to assess patients' recovery after bronchoscopy at PACU

    • 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).

    • 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

    • 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.

    • Defined as the total time spent between initial insertion of flexible bronchoscope and final withdrawal of such.

    • 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 dose requirement of nebulized lidocaine, pain medication and cough suppressors at PACU discharge.

    More Details

    NCT Number: NCT03613792
    Other IDs: 2018P000023
    Study URL: https://clinicaltrials.gov/study/NCT03613792
    Last updated: Sep 29, 2023