Remifentanil Plus Ketamine for Dynamic Flexible Bronchoscopy

NCT03613792 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 2018P000023
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchoscopy

Keywords

dynamic; flexible

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Numerical Rating Scale (NRS) for Discomfort

  Two hours after procedure conclusion, prior to patient discharge from the hospital

• ALDRETE score

  Two hours after procedure conclusion, prior to patient discharge from the hospital

• Clinician Satisfaction with Sedation Instrument (CSSI)

  Two hours after procedure conclusion, prior to patient discharge from the hospital

• Severity of Cough

  Two hours after procedure conclusion, prior to patient discharge from the hospital

• Incidence of Complications

  Two hours after procedure conclusion, prior to patient discharge from the hospital

Study Arms (2)

Remifentanil and Ketamine Group

ACTIVE COMPARATOR

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; Drug: Ketamine

Fentanyl and Midazolam

ACTIVE COMPARATOR

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; Drug: Midazolam

Interventions

Remifentanil DRUG

Opioid analgesic

Remifentanil and Ketamine Group

Fentanyl DRUG

Opioid analgesic

Fentanyl and Midazolam

Midazolam DRUG

Benzodiazepine

Also known as: Versed

Fentanyl and Midazolam

Ketamine DRUG

Analgesic

Remifentanil and Ketamine Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (\>18 years-old)
• Undergoing planned flexible bronchoscopy with dynamic maneuvers for Excessive Central Airway Collapse assessment at Beth Israel Deaconess Medical Center.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center (BIDMC)

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Interventions

Remifentanil; Fentanyl; Midazolam; Ketamine

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Satya Krishna Ramachandran, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair of Quality and Safety, Associate Professor of Anaesthesia

Study Record Dates

• First Submitted: July 30, 2018
• First Posted: August 3, 2018
• Study Start: September 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)