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临床试验/NCT06033729
NCT06033729已完成不适用

Remifentanil Target Controlled Infusion Versus Standard of Care for Conscious Sedation During US-guided Transbronchial Needle Aspiration (EBUS-TBNA): a Randomized, Prospective, Control Study

Scarlata, Simone, M.D.1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年9月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Patient, bronchoscopist and anesthesiologist's comfort and satisfaction to the procedure.

研究概览

简要总结

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.

详细描述

BACKGROUND Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a minimally invasive procedure that has gained major relevance in diagnosis lung cancer and staging of mediastinal lymph nodes (LN). Adequate sedation is an important part of the procedure since it improves patient's comfort and tolerance potentially positively affecting the diagnostic yield. It is also considered a standard of care for patients undergoing fiberoptic bronchoscopy unless specifically contraindicated.

The choice of the different level of sedation (from conscious to moderate to deep sedation) has always been challenging and, to date, no standardized practice exists. Deep sedation may be preferred in those cases where additional procedures such as placement of endobronchial stents, are required, or in order to make the procedure more suitable by limiting the patients motion. In remaining cases, conscious sedation allows to complain with the clinical demand without affecting respiratory and cardiovascular function, decreasing the cough reflex and maintaining sufficient swallowing capacity.

Not appropriate sedation can have serious complications, including respiratory depression or even arrest, hypoxia and/or hypercapnia, and cardiovascular and neurological side effects.

Commonly used drugs for sedation include propofol and a combination of benzodiazepines and opioids. However, achieving the ideal level of sedation can be challenging, since it may occasionally lead to over sedation, with detrimental effects. These risks are even greater if the patients present with lung disease, obesity, or heart disease. Conversely, under sedation can result in discomfort for the patient and challenging procedure it for the healthcare provider. Furthermore, benzodiazepines and medium-long-acting opioids continue their effect even after the procedure is finished, thus lasting the negative effects of these drugs over the time of the procedure.

In a recent case series, Scarlata and colleagues have provided a preliminary evidence of a TCI remifentanil protocol safety and effectiveness, providing an ideal and performant condition for bronchoscopists and a satisfactory comfort for patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

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;

干预措施: Remifentanil TCI (Drug)

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.

干预措施: Midazolam injection (Drug)

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.

干预措施: Fentanyl (Drug)

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.

干预措施: Propofol (Drug)

结局指标

主要结局

Patient, bronchoscopist and anesthesiologist's comfort and satisfaction to the procedure.

时间窗: At patient's dismission from bronchoscopy suit

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).

次要结局

  • Desaturation(Up to an hour from the end of the procedure)
  • Hypotension(Up to an hour from the end of the procedure)
  • Over sedation(During the procedure)
  • Airway support(Up to an hour from the and of the procedure)
  • Sampled lymph nodes(During the procedure)
  • Sampled lesions(During the procedure)
  • Level of sedation(During the procedure)
  • propofol boluses administered(During the procedure)
  • Procedure time(During the procedure)
  • Bradycardia(Up to an hour from the end of the procedure)
  • Bradypnea or respiratory arrest(Up to an hour from the end of the procedure)
  • Cough(Up to two hours from the end of the procedure)
  • Number of biopsies per limph node(During the procedure)
  • Number of biopsies per mass(During the procedure)

研究者

发起方
Scarlata, Simone, M.D.
申办方类型
Other
责任方
Principal Investigator
主要研究者

Simone Scarlata

Associate Professor in Internal Medicine

Scarlata, Simone, M.D.

研究点 (1)

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