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NCT06033729
Remifentanil Target Controlled Infusion Versus Standard of Care for Conscious Sedation During EBUS-TBNA
NA trial testing Remifentanil TCI in Lung Cancer in 30 participants. Completed in 17 January 2023.
1 July 2022
Quick facts
| Lead sponsor | Scarlata, Simone, M.D. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | supportive care |
| Enrollment | 30 |
| Start date | 20 September 2021 |
| Primary completion | 1 July 2022 |
| Estimated completion | 17 January 2023 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Remifentanil TCI — full drug profile →
- Midazolam injection — full drug profile →
- Fentanyl (fentanyl) — full drug profile →
- Propofol (Propofol) — full drug profile →
Conditions studied
- Lung Cancer — all drugs for Lung Cancer →
- Lung; Node — all drugs for Lung; Node →
- Sedation Complication — all drugs for Sedation Complication →
- Endoscopy — all drugs for Endoscopy →
Sponsor
Scarlata, Simone, M.D. — full company profile →
Who can join
Adults 18 to 80, any sex, with Lung Cancer or Lung; Node. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Background: endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a minimally invasive procedure for diagnosing and staging mediastinal lymph node lesions in lung cancer. Adequate sedation is crucial for patient comfort and diagnostic accuracy. Different sedation modalities, including moderate sedation/conscious sedation, deep sedation, and general anesthesia, are utilized. This study aims to evaluate patient comfort and satisfaction levels of healthcare providers (bronchoscopists and anesthesiologists) when administering remifentanil through Target Controlled Infusion (TCI) for conscious sedation during EBUS-TBNA. A prospective randomized study design compares this approach to the standard sedation protocol involving midazolam, fentanyl, and/or propofol. Methods: this study will enroll 30 eligible patients randomly divided into two groups. Group 1, "REMIFENTANIL TCI", underwent EBUS-TBNA under conscious sedation with remifentanil TCI infusion targeting a concentration of 3-6 ng/ml. Group 2, "STANDARD", received conscious sedation with a combination of midazolam, fentanyl, and/or propofol administered in boluses based on clinical requirements. Complications, safety, and satisfaction levels of the operator, anesthesiologist, and patients will be evaluated.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06033729
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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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 NCT06033729 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Scarlata, Simone, M.D.
- Last refreshed: 13 September 2023
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/NCT06033729.
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