Remifentanil Plus Ketamine for Dynamic Flexible Bronchoscopy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Drug: Remifentanil
Opioid analgesic
Drug: Ketamine
Analgesic
|
| 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 |
Drug: Fentanyl
Opioid analgesic
Drug: Midazolam
Benzodiazepine
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Patient Satisfaction with Sedation Instrument (PSSI) [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).
Secondary Outcome Measures
- Numerical Rating Scale (NRS) for Discomfort [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 [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) [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 [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 [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 [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 [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 [Until discharge from the PACU, on average one hour]
Total dose requirement of nebulized lidocaine, pain medication and cough suppressors at PACU discharge.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beth Israel Deaconess Medical Center (BIDMC) | Boston | Massachusetts | United States | 02215 |
Sponsors and Collaborators
- Beth Israel Deaconess Medical Center
Investigators
- Principal Investigator: Satya Krishna Ramachandran, MD, Beth Israel Deaconess Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2018P000023