NCT01158820

Alternative Sedation During Bronchoscopy

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sedation

Interventions

Type	Name	Description
DRUG	Dexmedetomidine load	Dexmedetomidine 1 µg/kg prior to bronchoscopy
DRUG	Ketamine load	Ketamine 30 mg bolus prior to bronchoscopy
DRUG	Midazolam load	2 mg bolus prior to bronchoscopy
DRUG	Fentanyl load	50 µg bolus prior to bronchoscopy
DRUG	Dexmedetomidine maintenance	0.5 µg/kg/hour for the duration of bronchoscopy (58.5 minutes average)
DRUG	Ketamine maintenance	8 µg/kg/min for the duration of bronchoscopy (58.5 minutes average)
DRUG	Midazolam demand	0.5 mg demand bolus at discretion of pulmonologist
DRUG	Fentanyl demand	12.5 µg demand bolus at discretion of pulmonologist
DRUG	Benadryl demand	25 mg bolus after 6th and 13th demand midazolam/fentanyl bolus

Timeline

• Start date: 2010-06-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2010-07-08
• Last updated: 2019-02-26
• Results posted: 2018-10-31

Locations

1 site across 1 country: United States