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Sedation Methods in Percutaneous Transhepatic Biliary Drainage: Procedure Quality and Recovery

2026年6月8日 更新者:Ankara City Hospital Bilkent

Evaluation of Sedation Methods Used in Percutaneous Transhepatic Biliary Drainage Procedures in Terms of Procedure Quality, Recovery Time, and Side Effects

This prospective, randomized, single-center study aims to evaluate and compare two different sedation and analgesia regimens used during percutaneous transhepatic biliary drainage (PTBD) procedures. A total of 96 adult patients undergoing elective PTBD or biliary stenting will be randomized to receive either propofol-remifentanil or propofol-ketamine sedation. The primary outcome is recovery time assessed using the Modified Aldrete Score. Secondary outcomes include procedure quality, pain scores, patient and operator satisfaction, hemodynamic stability, and the incidence of sedation-related adverse events. The study is designed to determine the optimal sedation strategy for PTBD, particularly in fragile and elderly patient populations.

研究概览

详细说明

Percutaneous transhepatic biliary drainage (PTBD) is a therapeutic procedure commonly performed in patients with biliary obstruction when surgical intervention or endoscopic retrograde cholangiopancreatography is not feasible. These patients frequently present with advanced age, malignancy, cholangitis, and significant comorbidities, making them particularly vulnerable to sedation-related complications.

Procedural sedation and analgesia are commonly used during interventional radiology procedures to ensure patient comfort, immobility, and procedural success. However, inadequate sedation may result in patient movement, increased anxiety, procedural failure, and complications, whereas excessive sedation may lead to hemodynamic instability, respiratory depression, and delayed recovery, especially in frail patients.

In this study, two commonly used sedation regimens-propofol combined with remifentanil and propofol combined with ketamine-will be compared. Both regimens are routinely used in non-operating room anesthesia settings in our institution. Patients will be randomly assigned in a 1:1 ratio to one of the two groups. Standard monitoring will be applied, including non-invasive blood pressure, electrocardiography, and pulse oximetry, with supplemental oxygen administered via nasal cannula.

Sedation depth will be targeted to a Ramsay Sedation Score of 3-4 and assessed every five minutes during the procedure. Hemodynamic parameters, oxygen saturation, pain scores, recovery time, and adverse events such as hypotension, bradycardia, hypoxia, nausea, vomiting, and airway interventions will be recorded. Recovery will be evaluated using the Modified Aldrete Score at two-minute intervals until adequate recovery is achieved.

The primary objective of the study is to compare recovery times between the two sedation regimens. Secondary objectives include comparison of pain intensity, patient and operator satisfaction, total drug consumption, procedural tolerance, and incidence of adverse events. The findings of this study aim to contribute to safer and more effective sedation strategies for PTBD procedures in high-risk patient populations.

研究类型

介入性

注册 (估计的)

98

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Scheduled for elective percutaneous transhepatic biliary drainage (PTBD) and/or biliary stenting
  • ASA physical status II-IV
  • Fasting time of at least 6 hours prior to the procedure
  • Ability to provide written informed consent

Exclusion Criteria:

  • Inability to provide informed consent or to complete study assessments (e.g., Ramsay Sedation Scale, FRAIL scale, Numeric Rating Scale)
  • Clinical diagnosis of Alzheimer's Disease
  • Clinical diagnosis of demantia
  • Known allergy or hypersensitivity to propofol, remifentanil, ketamine, ondansetron, or deksketoprofen
  • Grade 3-4 aortic, mitral, or tricuspid valve disease
  • Advanced or decompensated heart failure (ejection fraction <25%)
  • Emergency procedures
  • Refusal to participate in the study

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Propofol-Remifentanil
Participants received intravenous propofol 0.5 mg/kg followed by a continuous intravenous remifentanil infusion initiated at 0.10-0.18 mcg/kg/min during the procedure. The remifentanil infusion rate was adjusted within the specified range according to clinical response to maintain adequate sedation, analgesia, and hemodynamic stability throughout the procedure.
Intravenous propofol combined with remifentanil infusion for procedural sedation during percutaneous transhepatic biliary drainage.
实验性的:Propofol-Ketamine
IParticipants received intravenous propofol 0.5 mg/kg followed by intravenous ketamine 0.3 mg/kg. Additional intravenous ketamine 5 mg was administered every 5 minutes as needed during the procedure to maintain the target sedation level and hemodynamic stability.
Intravenous propofol combined with ketamine bolus for procedural sedation during percutaneous transhepatic biliary drainage.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Recovery Time
大体时间:From completion of the procedure until Modified Aldrete Score >8, assessed up to 30 minutes
Time to achieve adequate recovery assessed using the Modified Aldrete Score.
From completion of the procedure until Modified Aldrete Score >8, assessed up to 30 minutes

次要结果测量

结果测量
措施说明
大体时间
Hemodynamic Stability
大体时间:Baseline, every 5 minutes during the procedure (assessed up to 60 minutes), and immediately after the procedure.
Changes in systolic, diastolic, and mean arterial blood pressure, heart rate, and oxygen saturation during the procedure.
Baseline, every 5 minutes during the procedure (assessed up to 60 minutes), and immediately after the procedure.
Pain Intensity
大体时间:Baseline (pre-procedure), immediately after recovery, and at 30 minutes post-recovery.
Pain intensity assessed using the Numeric Rating Scale (NRS)
Baseline (pre-procedure), immediately after recovery, and at 30 minutes post-recovery.
Sedation Depth
大体时间:Every 5 minutes during the procedure, assessed up to 30 minutes.
Sedation level assessed using the Ramsay Sedation Scale.
Every 5 minutes during the procedure, assessed up to 30 minutes.
Adverse Events
大体时间:Perioperatively and through the recovery period, assessed up to 30 minutes.
Incidence of sedation-related adverse events including hypotension, bradycardia, hypoxia, apnea, nausea, and vomiting.
Perioperatively and through the recovery period, assessed up to 30 minutes.
Patient and Operator Satisfaction
大体时间:Immediately after the procedure
Patient and operator satisfaction assessed after completion of the procedure.
Immediately after the procedure

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年2月1日

初级完成 (估计的)

2026年5月30日

研究完成 (估计的)

2026年6月10日

研究注册日期

首次提交

2026年1月12日

首先提交符合 QC 标准的

2026年6月8日

首次发布 (实际的)

2026年6月10日

研究记录更新

最后更新发布 (实际的)

2026年6月10日

上次提交的符合 QC 标准的更新

2026年6月8日

最后验证

2026年1月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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