Alternative Sedation During Bronchoscopy

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Placebo-controlled, Concealed Allocation Comparison of Respiratory Depression and Coughing During Bronchoscopy With Dexmedetomidine-ketamine as an Adjunct to Fentanyl-midazolam Sedation

Conditions
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Sedation

Intervention / Treatment
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* Drug: Dexmedetomidine load
* Drug: Ketamine load
* Drug: Midazolam load
* Drug: Fentanyl load
* Drug: Dexmedetomidine maintenance
* Drug: Ketamine maintenance
* Drug: Midazolam demand
* Drug: Fentanyl demand
* Drug: Benadryl demand


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>midazolam load fentanyl load midazolam demand fentanyl demand benadryl demand | Drug: Midazolam load<br>* 2 mg bolus prior to bronchoscopy<br>* Other names: Versed;Drug: Fentanyl load<br>* 50 µg bolus prior to bronchoscopy<br>* Other names: Onsolis;Drug: Midazolam demand<br>* 0.5 mg demand bolus at discretion of pulmonologist<br>* Other names: Versed;Drug: Fentanyl demand<br>* 12.5 µg demand bolus at discretion of pulmonologist<br>* Other names: Onsolis;Drug: Benadryl demand<br>* 25 mg bolus after 6th and 13th demand midazolam/fentanyl bolus<br>* Other names: Siladryl;|
| Active Comparator: dexmedetomidine and ketamine<br>dexmedetomidine load ketamine load dexmedetomidine maintenance ketamine maintenance midazolam demand fentanyl demand benadryl demand | Drug: Dexmedetomidine load<br>* Dexmedetomidine 1 µg/kg prior to bronchoscopy<br>* Other names: Dexmedetomidine Hydrochloride;Drug: Ketamine load<br>* Ketamine 30 mg bolus prior to bronchoscopy<br>* Other names: Vetalar;Drug: Dexmedetomidine maintenance<br>* 0.5 µg/kg/hour for the duration of bronchoscopy (58.5 minutes average)<br>* Other names: Dexmedetomidine Hydrochloride;Drug: Ketamine maintenance<br>* 8 µg/kg/min for the duration of bronchoscopy (58.5 minutes average)<br>* Other names: Vetalar;Drug: Midazolam demand<br>* 0.5 mg demand bolus at discretion of pulmonologist<br>* Other names: Versed;Drug: Fentanyl demand<br>* 12.5 µg demand bolus at discretion of pulmonologist<br>* Other names: Onsolis;Drug: Benadryl demand<br>* 25 mg bolus after 6th and 13th demand midazolam/fentanyl bolus<br>* Other names: Siladryl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decreased Minute Ventilation | 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. | During the bronchoscopy procedure only, 58.5 minutes average | 
| Total Fentanyl | Total fentanyl dose delivered during the procedure | During the bronchoscopy procedure only, 58.5 minutes average | 
| Total Midazolam | Total midazolam delivered during procedure | Duration of procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Desaturation (Cumulative) | Cumulative time below saturation of 90% - the total number of seconds that the pulse oximeter reported a saturation below 90% | During the bronchoscopy procedure only, 58.5 minutes average | 
| Desaturation (Longest) | Longest time below saturation of 90% (the number of seconds elapsed between the start of a period in which the pulse oximeter saturation fell below 90% and the return above 90%) | During the bronchoscopy procedure only, 58.5 minutes average | 
| Conversion to General Anesthesia | Patients in which the procedure could not be completed without conversion to general anesthesia | During the bronchoscopy procedure only, 58.5 minutes average | 
| Patient Satisfaction | Satisfaction rated by 10 point Likert scale (0 = Totally dissatisfied, 10 = Totally satisfied) | After the bronchoscopy procedure only | 
| Endoscopist Satisfaction | Satisfaction rated by 10 point Likert scale (0 = Totally dissatisfied, 10 = Totally satisfied) | After the bronchoscopy procedure only | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bronchoscopy