Clinical trial

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

Name
2018P000023
Description
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.
Trial arms
Trial start
2023-09-01
Estimated PCD
2023-12-01
Trial end
2023-12-01
Status
Withdrawn
Phase
Early phase I
Treatment
Remifentanil
Opioid analgesic
Arms:
Remifentanil and Ketamine Group
Fentanyl
Opioid analgesic
Arms:
Fentanyl and Midazolam
Midazolam
Benzodiazepine
Arms:
Fentanyl and Midazolam
Other names:
Versed
Ketamine
Analgesic
Arms:
Remifentanil and Ketamine Group
Primary endpoint
Patient Satisfaction with Sedation Instrument (PSSI)
Two hours after procedure conclusion, prior to patient discharge from the hospital
Eligibility 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}
Updated at
2023-07-27

1 organization

2 products

1 drug

1 indication

Indication
Bronchoscopy
Product
Midazolam