Phase 4
N=50
Alternative Sedation During Bronchoscopy
Sedation
Bottom Line
View on ClinicalTrials.gov: NCT01158820 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcome: Primary: Decreased Minute Ventilation — 0.736; 0.764 percentage of baseline — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Dexmedetomidine load (Drug); Ketamine load (Drug); Midazolam load (Drug); Fentanyl load (Drug); Dexmedetomidine maintenance (Drug); Ketamine maintenance (Drug); Midazolam demand (Drug); Fentanyl demand (Drug); Benadryl demand (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Decreased Minute Ventilation |
0.736; 0.764 | <0.0001 sig |
| PRIMARY Total Fentanyl |
112.5; 68.75 | <0.01 sig |
| PRIMARY Total Midazolam |
4.5; 2.75 | 0.01 sig |
| SECONDARY Desaturation (Cumulative) |
39; 40 | — |
| SECONDARY Desaturation (Longest) |
21; 18 | — |
| SECONDARY Conversion to General Anesthesia |
6; 1 | — |
| SECONDARY Patient Satisfaction |
9; 10 | — |
| SECONDARY Endoscopist Satisfaction |
7; 8 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Adults over the age of 18 scheduled for elective flexible bronchoscopy in the endoscopy suite or OR of HUP
Exclusion Criteria
- History of inability to complete bronchoscopy attributable to inadequate sedation
- Requiring more than 2 LPM supplemental oxygen to maintain SaO2 > 90%
- History of allergy to study medications
- Pregnancy
- A history of psychosis
- Any condition deemed likely by the pulmonologist or anesthesiologist to pose a significant risk due to elevation of blood pressure, including cerebral/aortic aneurysm, and or ischemic cardiovascular disease
- Bradydysrhythmia deemed significant by the anesthesiologist or pulmonologist
- A diagnosis of significant renal or hepatic impairment
Data sourced from ClinicalTrials.gov (NCT01158820). 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.