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

Alternative Sedation During Bronchoscopy

Sponsors

Lead sponsor: University of Pennsylvania

Collaborator: Hospira, now a wholly owned subsidiary of Pfizer

Source 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.

Overall Status Completed
Start Date June 2010
Completion Date May 2012
Primary Completion Date May 2012
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Decreased Minute Ventilation During the bronchoscopy procedure only, 58.5 minutes average
Total Fentanyl During the bronchoscopy procedure only, 58.5 minutes average
Total Midazolam Duration of procedure
Secondary Outcome
Measure Time Frame
Desaturation (Cumulative) During the bronchoscopy procedure only, 58.5 minutes average
Desaturation (Longest) 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
Enrollment 50
Condition
Intervention

Intervention type: Drug

Intervention name: Dexmedetomidine load

Description: Dexmedetomidine 1 µg/kg prior to bronchoscopy

Arm group label: dexmedetomidine and ketamine

Intervention type: Drug

Intervention name: Ketamine load

Description: Ketamine 30 mg bolus prior to bronchoscopy

Arm group label: dexmedetomidine and ketamine

Intervention type: Drug

Intervention name: Midazolam load

Description: 2 mg bolus prior to bronchoscopy

Arm group label: Placebo

Other name: Versed

Intervention type: Drug

Intervention name: Fentanyl load

Description: 50 µg bolus prior to bronchoscopy

Arm group label: Placebo

Intervention type: Drug

Intervention name: Dexmedetomidine maintenance

Description: 0.5 µg/kg/hour for the duration of bronchoscopy (58.5 minutes average)

Arm group label: dexmedetomidine and ketamine

Intervention type: Drug

Intervention name: Ketamine maintenance

Description: 8 µg/kg/min for the duration of bronchoscopy (58.5 minutes average)

Arm group label: dexmedetomidine and ketamine

Intervention type: Drug

Intervention name: Midazolam demand

Description: 0.5 mg demand bolus at discretion of pulmonologist

Other name: Versed

Intervention type: Drug

Intervention name: Fentanyl demand

Description: 12.5 µg demand bolus at discretion of pulmonologist

Intervention type: Drug

Intervention name: Benadryl demand

Description: 25 mg bolus after 6th and 13th demand midazolam/fentanyl bolus

Eligibility

Criteria:

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

Gender: All

Minimum age: 18 Years

Maximum age: 90 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Jeff E Mandel, MD MS Principal Investigator University of Pennsylvania
Location
facility University of Pennsylvania
Location Countries

United States

Verification Date

February 2019

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Arm group label: Placebo

Arm group type: Placebo Comparator

Description: midazolam load fentanyl load midazolam demand fentanyl demand benadryl demand

Arm group label: dexmedetomidine and ketamine

Arm group type: Active Comparator

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

Acronym DEX
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

Source: ClinicalTrials.gov