CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 50 enrolled
Drug / intervention
Dexmedetomidine load +8 moredrug
Likely dose
Dexmedetomidine load 1 µgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01158820
NCT01158820Phase 4Completed

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 Pennsylvania·interventional·Posted Jul 8, 2010·Updated Feb 26, 2019

In Brief

A Phase 4 clinical trial evaluating Dexmedetomidine load, Ketamine load, and 7 other interventions for Sedation. Completed, enrolled 50 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSedation
CountriesUnited States

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 8, 2010
Enrollment StartJun 1, 2010
Primary CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 16.0 years ago

Interventions

Dexmedetomidine loaddrug

Dexmedetomidine 1 µg/kg prior to bronchoscopy

Ketamine loaddrug

Ketamine 30 mg bolus prior to bronchoscopy

Midazolam loaddrug

2 mg bolus prior to bronchoscopy

Fentanyl loaddrug

50 µg bolus prior to bronchoscopy

Dexmedetomidine maintenancedrug

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

Ketamine maintenancedrug

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

Midazolam demanddrug

0.5 mg demand bolus at discretion of pulmonologist

Fentanyl demanddrug

12.5 µg demand bolus at discretion of pulmonologist

Benadryl demanddrug

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