Clinical trial · Interventional
Fractionated Versus Target-controlled Propofol Administration in Bronchoscopy
Target-controlled Versus Manually-controlled Propofol Sedation in Flexible Bronchoscopy. A Randomized Non-inferiority Trial.
NCT02246023CI-TRIAL-00021744completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
After randomization, the subjects undergo flexible bronchoscopy either with fractionated propofol administration or with propofol-TCI. Measurement of blood pressure, heart rate, oxygen saturation, and oxygen requirement are measured continuously during the procedure and thereafter. Cumulative propofol dose, and induction, procedure, and recovery time are noted continuously during and after the procedure.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Interstitial Pneumonia | — | UNRESOLVED | — |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Sarcoidosis | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood pressure | Device | — | UNRESOLVED |
| Flexible bronchoscopy in moderate sedation | Device | — | UNRESOLVED |
| Oxygen saturation | Device | — | UNRESOLVED |
| Propofol dosage | Device | — | UNRESOLVED |
| Recovery time after bronchoscopy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Fractionated propofol administration
- description
- Flexible bronchoscopy in moderate sedation with fractionated propofol administrations: Patients receive an initial 20 mg of propofol, followed by a carefully titrated dose of10-20 mg propofol based on the clinical response. Continuous measurement of oxygen saturation Measurement of non-invasive blood pressure; Report of dose adjustments und cumulative propofol dosage; Recovery time after bronchoscopy
- interventionNames
- Device: Flexible bronchoscopy in moderate sedation
- Device: Oxygen saturation
- Device: Blood pressure
- Device: Propofol dosage
- Device: Recovery time after bronchoscopy
- type
- EXPERIMENTAL
- label
- Propofol-TCI
- description
- Flexible bronchoscopy in moderate sedation with TCI propofol perfusor: Flexible bronchoscopy is started after reaching the initial targeted effect-site concentration (Ce) of 2.5 μg/mL using the Schnider pharmacokinetic model described elsewhere. Thereafter, Ce is adjusted by increments of 0.2 μg/mL depending on the clinical effect, in order to maintain the required level of sedation. Continuous measurement of oxygen saturation Measurement of non-invasive blood pressure; Report of dose adjustments und cumulative propofol dosage; Recovery time after bronchoscopy The propofol-TCI perfusor is an active infusion system for fluid management. In the study, the Perfusor® Space of B. Braun AG, Melsungen is used exclusively.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects undergoing a planned, ambulatory flexible bronchoscopy (for transbronchial lung biopsy or endobronchial ultrasound guided procedures) in moderate sedation, aged between 18 and 85 years Exclusion Criteria: * History of solid organ or bone marrow transplantation with the use of an immunosuppressive therapy * HIV infection on anti-retroviral therapy * Alcohol consumption more than two standard drinks per day * Use of illicit drugs (heroin, opiates) * Any contraindication to use propofol for sedation (e.g. allergy) * Body mass index \> 35 kg/m2 * Mental disorder preventing appropriate judgment concerning study participation * Missing written patient's informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.