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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Beth Israel Deaconess Medical Center (BIDMC)
Boston, Massachusetts, United States
Patient Satisfaction with Sedation Instrument (PSSI)
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).
Time frame: Two hours after procedure conclusion, prior to patient discharge from the hospital
Numerical Rating Scale (NRS) for Discomfort
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).
Time frame: Two hours after procedure conclusion, prior to patient discharge from the hospital
ALDRETE score
The ALDRETE score (global assessment of post-anesthetic condition) is used to assess patients' recovery after bronchoscopy at PACU
Time frame: Two hours after procedure conclusion, prior to patient discharge from the hospital
Clinician Satisfaction with Sedation Instrument (CSSI)
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).
Time frame: Two hours after procedure conclusion, prior to patient discharge from the hospital
Severity of Cough
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Analgesic
Time frame: Two hours after procedure conclusion, prior to patient discharge from the hospital
Incidence of Complications
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.
Time frame: Two hours after procedure conclusion, prior to patient discharge from the hospital
Duration of Dynamic Flexible Bronchoscopy
Defined as the total time spent between initial insertion of flexible bronchoscope and final withdrawal of such.
Time frame: Two hours after procedure conclusion, prior to patient discharge from the hospital
PACU Length of Stay
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.
Time frame: Until discharge from the PACU, on average one hour
Total Nebulized Lidocaine Dose
Total dose requirement of nebulized lidocaine, pain medication and cough suppressors at PACU discharge.
Time frame: Until discharge from the PACU, on average one hour