Remifentanil Plus Ketamine for Dynamic Flexible Bronchoscopy

Bronchoscopy Clinical Trial

Official title:

Remifentanil Plus Ketamine Versus Midazolam Plus Fentanyl for Dynamic Flexible Bronchoscopy: Randomized Double-blind Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03613792
• Other study ID #: 2018P000023
• Status: Withdrawn
• Phase: Phase 4
• Start date: September 2023
• Est. completion date: December 2023

Study information

• Verified date: July 2023
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bronchoscopy

Intervention

Drug:
• Remifentanil
Opioid analgesic
• Fentanyl
Opioid analgesic
• Midazolam
Benzodiazepine
• Ketamine
Analgesic

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center (BIDMC)	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Two hours after procedure conclusion, prior to patient discharge from the hospital
Secondary	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).	Two hours after procedure conclusion, prior to patient discharge from the hospital
Secondary	ALDRETE score	The ALDRETE score (global assessment of post-anesthetic condition) is used to assess patients' recovery after bronchoscopy at PACU	Two hours after procedure conclusion, prior to patient discharge from the hospital
Secondary	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).	Two hours after procedure conclusion, prior to patient discharge from the hospital
Secondary	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	Two hours after procedure conclusion, prior to patient discharge from the hospital
Secondary	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.	Two hours after procedure conclusion, prior to patient discharge from the hospital
Secondary	Duration of Dynamic Flexible Bronchoscopy	Defined as the total time spent between initial insertion of flexible bronchoscope and final withdrawal of such.	Two hours after procedure conclusion, prior to patient discharge from the hospital
Secondary	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.	Until discharge from the PACU, on average one hour
Secondary	Total Nebulized Lidocaine Dose	Total dose requirement of nebulized lidocaine, pain medication and cough suppressors at PACU discharge.	Until discharge from the PACU, on average one hour