Lung Cancer Clinical Trial
Official title:
Remifentanil Target Controlled Infusion Versus Standard of Care for Conscious Sedation During US-guided Transbronchial Needle Aspiration (EBUS-TBNA): a Randomized, Prospective, Control Study
Verified date | September 2023 |
Source | Scarlata, Simone, M.D. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | January 17, 2023 |
Est. primary completion date | July 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - patients aged 18-80 years, - clinical fit to undergo the planned procedure, according to the American Society of Anesthesiologists physical status classification. Exclusion Criteria: - current chronic opioid treatment, - substance abuse or drug use; - pregnancy, - history of allergy to related medications; - severe coagulation dysfunction; - severe hepatic - renal dysfunction; - history of abnormal recovery from anesthesia; - acute respiratory failure; - inability or unwillingness to provide informed consent. |
Country | Name | City | State |
---|---|---|---|
Italy | Università Campus Bio Medico | Roma |
Lead Sponsor | Collaborator |
---|---|
Scarlata, Simone, M.D. |
Italy,
Aswanetmanee P, Limsuwat C, Kabach M, Alraiyes AH, Kheir F. The role of sedation in endobronchial ultrasound-guided transbronchial needle aspiration: Systematic review. Endosc Ultrasound. 2016 Sep-Oct;5(5):300-306. doi: 10.4103/2303-9027.191608. — View Citation
Scarlata S, Costa F, Pascarella G, Strumia A, Antonelli Incalzi R, Agro FE. Remifentanil Target-Controlled Infusion for Conscious Sedation in Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA): A Case Series. Clin Drug Investig. — View Citation
Wahidi MM, Jain P, Jantz M, Lee P, Mackensen GB, Barbour SY, Lamb C, Silvestri GA. American College of Chest Physicians consensus statement on the use of topical anesthesia, analgesia, and sedation during flexible bronchoscopy in adult patients. Chest. 20 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient, bronchoscopist and anesthesiologist's comfort and satisfaction to the procedure. | the patient was given a satisfaction questionnaire to evaluate the degree of satisfaction. The 0-5 Likert numerical scale was used to evaluate the symptoms onset of cough (0 none-5 very much), sore throat (0-5), chest pain (0-5), shortness of breath (0 eupnoea- 5 worsening dyspnea), presence of memories (0 none - 5 vivid memories), and perioperative comfort (0 none - 5 excellent). The operator who performed the procedure and the sedation were also subjected to a satisfaction questionnaire which assessed the overall satisfaction (1 much worse than usual - 5 much better than usual). | At patient's dismission from bronchoscopy suit | |
Secondary | propofol boluses administered | Number and dosage of any propofol boluses administered (both in the experimental group and in the control group) | During the procedure | |
Secondary | Procedure time | Total duration of the procedure (in minutes) | During the procedure | |
Secondary | Level of sedation | Level of sedation achieved (Ramsey score) | During the procedure | |
Secondary | Over sedation | Episodes of over-sedation (Ramsey score > 3) | During the procedure | |
Secondary | Desaturation | Desaturation episodes | Up to an hour from the end of the procedure | |
Secondary | Hypotension | Episodes of hypotension (SBP <90 mmHg) | Up to an hour from the end of the procedure | |
Secondary | Bradycardia | Episodes of Bradycardia (HR<60) | Up to an hour from the end of the procedure | |
Secondary | Bradypnea or respiratory arrest | Episodes of bradypnea (RR<10) | Up to an hour from the end of the procedure | |
Secondary | Cough | Excessive cough (Unconfortable, unconstrained cough affecting patient's and operator comfort) | Up to two hours from the end of the procedure | |
Secondary | Airway support | Need for airway support | Up to an hour from the and of the procedure | |
Secondary | Sampled lymph nodes | Number of lymph nodes sampled during the procedure. | During the procedure | |
Secondary | Sampled lesions | Number of masses sampled during the procedure. | During the procedure | |
Secondary | Number of biopsies per limph node | Number of biopsies per single lymph node needed to obtain a confident sample size according to a visual on-site evaluation. | During the procedure | |
Secondary | Number of biopsies per mass | Number of biopsies per single mass needed to obtain a confident sample size according to a visual on-site evaluation | During the procedure |
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