Alternative Sedation During Bronchoscopy

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.

Conditions

• Sedation

Interventions

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

Sponsors & Collaborators

• Hospira, now a wholly owned subsidiary of Pfizer

  collaborator INDUSTRY

• University of Pennsylvania

  lead OTHER

Principal Investigators

• Jeff E Mandel, MD MS · University of Pennsylvania

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-06-30

Primary Completion

2012-05-31

Completion

2012-05-31

Countries

• United States

Study Locations