Status:

UNKNOWN

Nurse Administered Propofol Sedation vs. Midazolam With Fentanyl-sedation for Flexible Bronchoscopy: A Randomized, Single Blind, Controlled Study of Satisfaction and Safety.

Lead Sponsor:

Copenhagen University Hospital at Herlev

Conditions:

Flexible Bronchoscopy

Sedation

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief Summary

Flexible bronchoscopy almost always requires sedation to be successful. In order to increase the availability of propofol for sedation, non-anaesthesiologist administered propofol sedation has been su...

Eligibility Criteria

Inclusion

  • Elective flexible bronchoscopy.
  • Willing to be randomised
  • Provide written informed consent

Exclusion

  • Allergy to contents administered
  • pregnant or nursing
  • \<18 years of age
  • Not able to complete questionnaire
  • Acute condition
  • severe COPD
  • \> ASA II
  • Sleep apnea
  • Risk of aspiration
  • Previously difficulty with anesthesia
  • Difficult airway

Key Trial Info

Start Date :

November 1 2014

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

April 1 2016

Estimated Enrollment :

128 Patients enrolled

Trial Details

Trial ID

NCT02226328

Start Date

November 1 2014

End Date

April 1 2016

Last Update

June 30 2015

Active Locations (1)

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1

Gentofte Hospital

Hellerup, Denmark, 2900