Phase 4
Completed N=50
Alternative Sedation During Bronchoscopy
Source: ClinicalTrials.gov NCT01158820 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcomePrimary: Decreased Minute Ventilation — 0.736; 0.764 percentage of baseline — p=<0.0001
◆ Published Evidence
Highly cited
115citations · ~9 / year
Comparison of moderate versus deep sedation for endobronchial ultrasound transbronchial needle aspiration.
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.
Linked Publications
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Comparison of moderate versus deep sedation for endobronchial ultrasound transbronchial needle aspiration.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.