A Randomized, Placebo-controlled, Concealed Allocation Comparison of Respiratory Depression and Coughing During Bronchoscopy With Dexmedetomidine-ketamine as an Adjunct to Fentanyl-midazolam Sedation
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- University of Pennsylvania
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Total Midazolam
Study Overview
Brief Summary
This protocol hopes to determine whether the use of dexmedetomidine-ketamine can reduce the use of standard of care fentanyl-midazolam sedation during bronchoscopy. This may result in less respiratory depression while providing better compliance with the procedure.
Detailed Description
All patients enrolled in the study will be undergoing bronchoscopy, which is typically performed with sedation. All procedural sedation carries some risk. Several features of the study may lower the risk of sedation relative to that of conventional sedation. An anesthesiologist will be present throughout the procedure. Continuous monitoring of respiration with RIP will be employed. Administration of sedation will be via a volumetric syringe pump. Benefits specific to dexmedetomidine-ketamine include the lack of respiratory depression and greater hemodynamic stability.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults over the age of 18 scheduled for elective flexible bronchoscopy in the endoscopy suite or OR of HUP
Exclusion Criteria
- •History of inability to complete bronchoscopy attributable to inadequate sedation
- •Requiring more than 2 LPM supplemental oxygen to maintain SaO2 > 90%
- •History of allergy to study medications
- •Pregnancy
- •A history of psychosis
- •Any condition deemed likely by the pulmonologist or anesthesiologist to pose a significant risk due to elevation of blood pressure, including cerebral/aortic aneurysm, and or ischemic cardiovascular disease
- •Bradydysrhythmia deemed significant by the anesthesiologist or pulmonologist
- •A diagnosis of significant renal or hepatic impairment
Arms & Interventions
Placebo
midazolam load fentanyl load midazolam demand fentanyl demand benadryl demand
Intervention: Midazolam load (Drug)
Placebo
midazolam load fentanyl load midazolam demand fentanyl demand benadryl demand
Intervention: Fentanyl load (Drug)
Placebo
midazolam load fentanyl load midazolam demand fentanyl demand benadryl demand
Intervention: Midazolam demand (Drug)
Placebo
midazolam load fentanyl load midazolam demand fentanyl demand benadryl demand
Intervention: Fentanyl demand (Drug)
Placebo
midazolam load fentanyl load midazolam demand fentanyl demand benadryl demand
Intervention: Benadryl demand (Drug)
dexmedetomidine and ketamine
dexmedetomidine load ketamine load dexmedetomidine maintenance ketamine maintenance midazolam demand fentanyl demand benadryl demand
Intervention: Dexmedetomidine load (Drug)
dexmedetomidine and ketamine
dexmedetomidine load ketamine load dexmedetomidine maintenance ketamine maintenance midazolam demand fentanyl demand benadryl demand
Intervention: Ketamine load (Drug)
dexmedetomidine and ketamine
dexmedetomidine load ketamine load dexmedetomidine maintenance ketamine maintenance midazolam demand fentanyl demand benadryl demand
Intervention: Dexmedetomidine maintenance (Drug)
dexmedetomidine and ketamine
dexmedetomidine load ketamine load dexmedetomidine maintenance ketamine maintenance midazolam demand fentanyl demand benadryl demand
Intervention: Ketamine maintenance (Drug)
dexmedetomidine and ketamine
dexmedetomidine load ketamine load dexmedetomidine maintenance ketamine maintenance midazolam demand fentanyl demand benadryl demand
Intervention: Midazolam demand (Drug)
dexmedetomidine and ketamine
dexmedetomidine load ketamine load dexmedetomidine maintenance ketamine maintenance midazolam demand fentanyl demand benadryl demand
Intervention: Fentanyl demand (Drug)
dexmedetomidine and ketamine
dexmedetomidine load ketamine load dexmedetomidine maintenance ketamine maintenance midazolam demand fentanyl demand benadryl demand
Intervention: Benadryl demand (Drug)
Outcomes
Primary Outcomes
Total Midazolam
Time Frame: Duration of procedure
Total midazolam delivered during procedure
Decreased Minute Ventilation
Time Frame: During the bronchoscopy procedure only, 58.5 minutes average
An initial baseline minute ventilation estimate was obtained via calibrated respiratory impedance plethysmography bands. Subsequent minute ventilation was normalized to this value. Values exceeding 100% were excluded from analysis, as these typically reflected a period of hyperpnea subsequent to relief of airway obstruction by chin lift or jaw thrust.
Total Fentanyl
Time Frame: During the bronchoscopy procedure only, 58.5 minutes average
Total fentanyl dose delivered during the procedure
Secondary Outcomes
- Desaturation (Cumulative)(During the bronchoscopy procedure only, 58.5 minutes average)
- Conversion to General Anesthesia(During the bronchoscopy procedure only, 58.5 minutes average)
- Patient Satisfaction(After the bronchoscopy procedure only)
- Endoscopist Satisfaction(After the bronchoscopy procedure only)
- Desaturation (Longest)(During the bronchoscopy procedure only, 58.5 minutes average)