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 enrollmentJune 2010

InterventionsMidazolam load Fentanyl load Midazolam demand Fentanyl demand Benadryl demand Dexmedetomidine load Ketamine load Dexmedetomidine maintenance Ketamine maintenance

DrugsDexmedetomidine load Ketamine load Midazolam load Fentanyl load Dexmedetomidine maintenance Ketamine maintenance Midazolam demand Fentanyl demand Benadryl demand

Overview

Phase: Phase 4
Intervention: Midazolam load
Conditions: Sedation
Sponsor: University of Pennsylvania
Enrollment: 50
Locations: 1
Primary Endpoint: Total Midazolam
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

June 2010

End Date

May 2012

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Pennsylvania

Responsible Party

Sponsor

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

Arms & Interventions

Placebo

midazolam load fentanyl load midazolam demand fentanyl demand benadryl demand

Intervention: Midazolam load

Placebo

midazolam load fentanyl load midazolam demand fentanyl demand benadryl demand

Intervention: Fentanyl load

Placebo

midazolam load fentanyl load midazolam demand fentanyl demand benadryl demand

Intervention: Midazolam demand

Placebo

midazolam load fentanyl load midazolam demand fentanyl demand benadryl demand

Intervention: Fentanyl demand