Remifentanil Plus Ketamine for Dynamic Flexible Bronchoscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-30

Study Completion Date

2023-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Bronchoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Remifentanil

Intervention Type DRUG

Opioid analgesic

Ketamine

Intervention Type DRUG

Analgesic

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

Group Type ACTIVE_COMPARATOR

Fentanyl

Intervention Type DRUG

Opioid analgesic

Midazolam

Intervention Type DRUG

Benzodiazepine

Interventions

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Remifentanil

Opioid analgesic

Intervention Type DRUG

Fentanyl

Opioid analgesic

Intervention Type DRUG

Midazolam

Benzodiazepine

Intervention Type DRUG

Ketamine

Analgesic

Intervention Type DRUG

Other Intervention Names

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Versed

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No