N/A
N=102
Non-anesthesiologist-administered Propofol During the Flexible Bronchoscopy
Conscious Sedation Failure During Procedure
Bottom Line
View on ClinicalTrials.gov: NCT02820051 ↗Enrolled (actual)
102
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Change in Transcutaneous CO2 Pressure — 43.6; 45.6 Unit of Measure "mmHg" — p=0.281
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transcutaneous CO2 monitor (Device); Midazolam (Drug); Propofol (Drug); Nalbuphine (Drug); Lidocaine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Transcutaneous CO2 Pressure |
43.6; 45.6 | 0.281 |
| SECONDARY Residual Sedation Assessed Using the Aldrete Scale |
10; 10 | <0.05 sig |
| SECONDARY Patient Comfort Assessed Using a Satisfaction Questionnaire |
8.41; 8.97 | <0.05 sig |
Summary
Flexible bronchoscopy (FB) is a fundamental procedure for the diagnosis and treatment of respiratory diseases. Although midazolam is the recommended sedative agent by most guidelines, propofol has gained popularity due a short recovery time, however, evidence to propofol use for sedation during FB is scarce. There is little evidence about transcutaneous CO2 pressure (PtcCO2) behavior among patients sedated with propofol when it is administered by non-anesthesiologist and in combination with intravenous opioids for analgesia and cough inhibition.
The investigators performed a randomized controlled trial to determine whether non-anesthesiology-administered balanced-sedation with propofol was related to high values of values of PtcCO2 compared with guideline-based sedation (midazolam and opioid). The investigators included data from outpatients 18 years or older with an indication for FB in a university hospital in northern of Mexico. Secondary outcomes were recuperation time, patient satisfaction and adverse effects.
Eligibility Criteria
Inclusion Criteria
- Ambulatory patients aged > 18 years with an indication for flexible bronchoscopy.
Exclusion Criteria
- tracheostomy
- known allergy to drugs used during procedural sedation
- inability to answer the satisfaction questionnaires
- psychiatric illness, pregnancy
- ASA class IV or V
Data sourced from ClinicalTrials.gov (NCT02820051). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.