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NCT06060626
Optimization of Sedation Protocol for Endoscopic Procedures Using Impedance Ventilation Monitor.
NA trial testing Sedation using only Propofol. in Sedation Complication in 50 participants. Completed in 22 January 2025.
22 January 2025
Quick facts
| Lead sponsor | Charles University, Czech Republic |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | supportive care |
| Enrollment | 50 |
| Start date | 16 November 2023 |
| Primary completion | 22 January 2025 |
| Estimated completion | 22 January 2025 |
| Sites | 1 location across Czechia |
Drugs / interventions tested
- Sedation using only Propofol. — full drug profile →
- Sedation using combination of Propofol and Fentanyl. — full drug profile →
Conditions studied
- Sedation Complication — all drugs for Sedation Complication →
- Ventilatory Depression — all drugs for Ventilatory Depression →
Sponsor
Charles University, Czech Republic
Who can join
Adults 18 to 65, any sex, with Sedation Complication or Ventilatory Depression. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The aim of the study is to evaluate the effect of opioids administered during sedation on patients' respiratory activity (ventilation) and comfort of the operator and patient during the endoscopic procedure. A common side effect of sedation is the effect on patients' ventilation, resulting from a combination of attenuation of respiratory centre activity and loss of patent airways. Shallow sedation will reduce these risks, but in addition to patient discomfort, it also increases the difficulty or impossibility of the endoscopist to perform the procedure. Choosing the appropriate method of sedation thus fundamentally affects the course of the procedure from the point of view of both the patient and the endoscopist. The aim is to prove that sedation with propofol alone compared to sedation with propofol and fentanyl premedication leads to the need for higher cumulative doses of administered propofol, higher risk of respiratory depression and lower patient and operator comfort. In addition, the non-invasive respiratory volume monitor (ExSpiron 2Xi) will be used for standard patient monitoring during the procedure, which assesses the lung tidal volume and respiratory rate by measuring the electrical impedance of the chest. This measurement captures inadequate ventilation before saturation drops, allowing even slight differences between selected drugs to be compared.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Impact of opioid addition on procedural conditions during colonoscopy: a randomized trial comparing propofol-based sedation protocols.
Novotny D, Palenik J, Tyll T, Brodyuk N, et al · · 2025 · cited 1× · PMID 40611561 · DOI 10.5946/ce.2024.347
Verify or expand the search:
- PubMed search for NCT06060626
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Sedation Complication
Currently open trials in the same condition.
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- NCT07456111 — A Comparison of Remimazolam Besylate and Propofol Sedation in Patients Undergoing Colonoscopic Polypectomy · Phase 4 · recruiting
- NCT06769308 — Effect of Goal-directed Analgesia and Sedation Using EEG Derived QCON/qNOX in ICU Patients · NA · recruiting
- NCT05371886 — Pharmacokinetics-pharmacodynamics of Morphine With or Without Midazolam Administered by Continuous Infusion in Neonatal · NA · recruiting
- NCT05765162 — Safe Brain Initiative, Operationalizing Precision Anaesthesia · recruiting
Other Charles University, Czech Republic trials
Trials by the same sponsor.
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- NCT07525154 — Development of a Certified Testing Procedure for Hip and Groin Injuries in Athletes · NA · not yet recruiting
- NCT07512570 — Feasibility and Preliminary Effects of a Structured Resistance Training Program in Children Aged 10-14 Years · NA · not yet recruiting
- NCT07424326 — Extended Ablation Versus Pulmonary Vein Isolation to Treat Persistent Atrial Fibrillation · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06060626 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Charles University, Czech Republic
- Last refreshed: 28 January 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06060626.
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