Remifentanil Target Controlled Infusion Versus Standard of Care for Conscious Sedation During EBUS-TBNA

NCT06033729 | Completed

• 1 other identifier: CBM 20-12
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer; Lung; Node; Sedation Complication; Endoscopy

Keywords

endobronchial ultrasound; mediastinal staging of lung cancer; sedation in endoscopic procedures

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• propofol boluses administered

  During the procedure

• Procedure time

  During the procedure

• Level of sedation

  During the procedure

• Over sedation

  During the procedure

• Desaturation

  Up to an hour from the end of the procedure

Study Arms (2)

Group 1 "REMIFENTANIL TCI" (Experimental Group)

EXPERIMENTAL

the patients performed the EBUS-TBNA procedure under conscious sedation with infusion of Remifentanil TCI with a target between 3 and 6 ng/ml;

Drug: Remifentanil TCI

Group 2 "STANDARD" (Control Group)

ACTIVE COMPARATOR

the patients performed the EBUS-TBNA procedure in conscious sedation with the association of midazolam and/or fentanyl and/or propofol in refracted boluses based on clinical needs (agitation, unsatisfactory level of sedation or not collaborative patient) and according to the anesthesiologist's clinical judgement.

Drug: Midazolam injection; Drug: Fentanyl; Drug: Propofol

Interventions

Remifentanil TCI DRUG

REMI-TCI administration begun 5 minutes before the procedure, starting from an initial target at the effect site of 1 ng/ml and gradually increasing by 0.5 ng/ml until reaching an adequate level of sedation (Ramsey score between 2-3).

Also known as: REMI - target control infusion

Group 1 "REMIFENTANIL TCI" (Experimental Group)

Midazolam injection DRUG

Bolus administration of midazolam (1-2 mg)and/or until a Ramsey score 2-3 was reached

Also known as: Bolus administration of midazolam

Group 2 "STANDARD" (Control Group)

Fentanyl DRUG

Bolus adminitration of fentanyl (50-100 mcg) until a Ramsey score 2-3 was reached

Also known as: Bolus administration of Fentanyl

Group 2 "STANDARD" (Control Group)

Propofol DRUG

Bolus adminitration of propofol until a Ramsey score 2-3 was reached

Also known as: Bolus administration of Propofol

Group 2 "STANDARD" (Control Group)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients aged 18-80 years,
• clinical fit to undergo the planned procedure, according to the American Society of Anesthesiologists physical status classification.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Scarlata, Simone, M.D.: lead

Study Sites (1)

Università Campus Bio Medico

Roma, 00128, Italy

Location

Related Publications (3)

• 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. 2011 Nov;140(5):1342-1350. doi: 10.1378/chest.10-3361.

  PMID: 22045879 RESULT

• 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.

  PMID: 27803902 RESULT

• 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. 2020 Oct;40(10):985-988. doi: 10.1007/s40261-020-00960-0. No abstract available.

  PMID: 32767252 RESULT

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Midazolam; Fentanyl; Propofol

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The bronchoscopist, the patient and the research assistant administrating the questionnaires were blinded to the assigned group. It was not possible to blind anesthesiologists involved in the patient's care.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Internal Medicine

Model Details: Informed consent was obtained from each patient or legally authorized representative prior to enrollment in this study. After obtaining a signed informed consent the patient was randomly allocated 1:1 to the group "REMIFENTANIL TCI" or "STANDARD". A research randomizer software was used for randomization (iRANDOMIZER-SHMOOPI LLC-version 2.5).

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: September 13, 2023
• Study Start: September 20, 2021
• Primary Completion: July 1, 2022
• Study Completion: January 17, 2023
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)