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Clinical Trials/NCT01158820
NCT01158820CompletedPhase 4

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

University of Pennsylvania1 site in 1 country50 target enrollmentStarted: June 2010Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
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

Placebo Comparator

midazolam load fentanyl load midazolam demand fentanyl demand benadryl demand

Intervention: Midazolam load (Drug)

Placebo

Placebo Comparator

midazolam load fentanyl load midazolam demand fentanyl demand benadryl demand

Intervention: Fentanyl load (Drug)

Placebo

Placebo Comparator

midazolam load fentanyl load midazolam demand fentanyl demand benadryl demand

Intervention: Midazolam demand (Drug)

Placebo

Placebo Comparator

midazolam load fentanyl load midazolam demand fentanyl demand benadryl demand

Intervention: Fentanyl demand (Drug)

Placebo

Placebo Comparator

midazolam load fentanyl load midazolam demand fentanyl demand benadryl demand

Intervention: Benadryl demand (Drug)

dexmedetomidine and ketamine

Active Comparator

dexmedetomidine load ketamine load dexmedetomidine maintenance ketamine maintenance midazolam demand fentanyl demand benadryl demand

Intervention: Dexmedetomidine load (Drug)

dexmedetomidine and ketamine

Active Comparator

dexmedetomidine load ketamine load dexmedetomidine maintenance ketamine maintenance midazolam demand fentanyl demand benadryl demand

Intervention: Ketamine load (Drug)

dexmedetomidine and ketamine

Active Comparator

dexmedetomidine load ketamine load dexmedetomidine maintenance ketamine maintenance midazolam demand fentanyl demand benadryl demand

Intervention: Dexmedetomidine maintenance (Drug)

dexmedetomidine and ketamine

Active Comparator

dexmedetomidine load ketamine load dexmedetomidine maintenance ketamine maintenance midazolam demand fentanyl demand benadryl demand

Intervention: Ketamine maintenance (Drug)

dexmedetomidine and ketamine

Active Comparator

dexmedetomidine load ketamine load dexmedetomidine maintenance ketamine maintenance midazolam demand fentanyl demand benadryl demand

Intervention: Midazolam demand (Drug)

dexmedetomidine and ketamine

Active Comparator

dexmedetomidine load ketamine load dexmedetomidine maintenance ketamine maintenance midazolam demand fentanyl demand benadryl demand

Intervention: Fentanyl demand (Drug)

dexmedetomidine and ketamine

Active Comparator

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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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