Remifentanil Plus Ketamine for Dynamic Flexible Bronchoscopy

Beth Israel Lahey Health

Status and phase: Withdrawn; Phase 4

Conditions: Bronchoscopy

Treatments: Drug: Ketamine; Drug: Midazolam; Drug: Remifentanil; Drug: Fentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT03613792

2018P000023

Details and patient eligibility

About

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.

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Remifentanil and Ketamine Group

Active Comparator group

Description:

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.

Treatment:

Drug: Remifentanil

Drug: Ketamine

Fentanyl and Midazolam

Active Comparator group

Description:

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

Treatment:

Drug: Midazolam

Drug: Fentanyl