Clinical trial NCT03613792: Remifentanil Plus Ketamine for Dynamic Flexible Bronchoscopy
Official title: Remifentanil Plus Ketamine Versus Midazolam Plus Fentanyl for Dynamic Flexible Bronchoscopy: Randomized Double-blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Bronchoscopy
Keywords: dynamic
flexible
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2018-08-03
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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:
measure: Patient Satisfaction with Sedation Instrument (PSSI)
timeFrame: Two hours after procedure conclusion, prior to patient discharge from the hospital
Secondary outcomes:
measure: Numerical Rating Scale (NRS) for Discomfort
timeFrame: Two hours after procedure conclusion, prior to patient discharge from the hospital
measure: ALDRETE score
timeFrame: Two hours after procedure conclusion, prior to patient discharge from the hospital
measure: Clinician Satisfaction with Sedation Instrument (CSSI)
timeFrame: Two hours after procedure conclusion, prior to patient discharge from the hospital
measure: Severity of Cough
timeFrame: Two hours after procedure conclusion, prior to patient discharge from the hospital
measure: Incidence of Complications
timeFrame: Two hours after procedure conclusion, prior to patient discharge from the hospital
measure: Duration of Dynamic Flexible Bronchoscopy
timeFrame: Two hours after procedure conclusion, prior to patient discharge from the hospital
measure: PACU Length of Stay
timeFrame: Until discharge from the PACU, on average one hour
measure: Total Nebulized Lidocaine Dose
timeFrame: Until discharge from the PACU, on average one hour
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center (BIDMC)
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Satya Krishna Ramachandran, MD
role: PRINCIPAL_INVESTIGATOR
References: