Alternative Sedation During Bronchoscopy

Phase 4

Completed

• Conditions: Sedation
• Interventions: Drug: Midazolam load; Drug: Dexmedetomidine load; Drug: Fentanyl load; Drug: Ketamine load; Drug: Dexmedetomidine maintenance; Drug: Fentanyl demand; Drug: Ketamine maintenance; Drug: Benadryl demand; Drug: Midazolam demand

• Registration Number: NCT01158820
• Lead Sponsor: University of Pennsylvania

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-25
• Study First Submitted QC: 2010-07-07
• Study First Posted: 2010-07-08
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Results First Submitted: 2018-08-29
• Results First Submitted QC: 2018-10-03
• Results First Posted: 2018-10-31
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-05
• Last Update Posted: 2019-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Adults over the age of 18 scheduled for elective flexible bronchoscopy in the endoscopy suite or OR of HUP

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Fentanyl demand	midazolam load fentanyl load midazolam demand fentanyl demand benadryl demand
Placebo	Midazolam load	midazolam load fentanyl load midazolam demand fentanyl demand benadryl demand
Placebo	Fentanyl load	midazolam load fentanyl load midazolam demand fentanyl demand benadryl demand
dexmedetomidine and ketamine	Ketamine load	dexmedetomidine load ketamine load dexmedetomidine maintenance ketamine maintenance midazolam demand fentanyl demand benadryl demand
dexmedetomidine and ketamine	Fentanyl demand	dexmedetomidine load ketamine load dexmedetomidine maintenance ketamine maintenance midazolam demand fentanyl demand benadryl demand
Placebo	Benadryl demand	midazolam load fentanyl load midazolam demand fentanyl demand benadryl demand
dexmedetomidine and ketamine	Ketamine maintenance	dexmedetomidine load ketamine load dexmedetomidine maintenance ketamine maintenance midazolam demand fentanyl demand benadryl demand
dexmedetomidine and ketamine	Benadryl demand	dexmedetomidine load ketamine load dexmedetomidine maintenance ketamine maintenance midazolam demand fentanyl demand benadryl demand
dexmedetomidine and ketamine	Dexmedetomidine maintenance	dexmedetomidine load ketamine load dexmedetomidine maintenance ketamine maintenance midazolam demand fentanyl demand benadryl demand
dexmedetomidine and ketamine	Midazolam demand	dexmedetomidine load ketamine load dexmedetomidine maintenance ketamine maintenance midazolam demand fentanyl demand benadryl demand
Placebo	Midazolam demand	midazolam load fentanyl load midazolam demand fentanyl demand benadryl demand
dexmedetomidine and ketamine	Dexmedetomidine load	dexmedetomidine load ketamine load dexmedetomidine maintenance ketamine maintenance midazolam demand fentanyl demand benadryl demand

Primary Outcome Measures

Name	Time	Method
Total Midazolam	Duration of procedure	Total midazolam delivered during procedure
Decreased Minute Ventilation	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	During the bronchoscopy procedure only, 58.5 minutes average	Total fentanyl dose delivered during the procedure

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States