Sedation Methods in Percutaneous Transhepatic Biliary Drainage: Procedure Quality and Recovery
Evaluation of Sedation Methods Used in Percutaneous Transhepatic Biliary Drainage Procedures in Terms of Procedure Quality, Recovery Time, and Side Effects
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Ankara
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Ankara、Ankara、トルコ（Türkiye）、06800
- 募集
- Ankara Bilkent City Hospital
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コンタクト：
- Mücahid MD Mutlu, Resident
- 電話番号：+905078260298
- メール：mucahid.mutlu@gmail.com
-
コンタクト：
- Mücahid Mutlu
- 電話番号：+905078260298
- メール：mucahid.mutlu@gmail.com
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
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Intravenous propofol combined with remifentanil infusion for procedural sedation during percutaneous transhepatic biliary drainage.
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実験的：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.
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Intravenous propofol combined with ketamine bolus for procedural sedation during percutaneous transhepatic biliary drainage.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Recovery Time
時間枠：From completion of the procedure until Modified Aldrete Score >8, assessed up to 30 minutes
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Time to achieve adequate recovery assessed using the Modified Aldrete Score.
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From completion of the procedure until Modified Aldrete Score >8, assessed up to 30 minutes
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Hemodynamic Stability
時間枠：Baseline, every 5 minutes during the procedure (assessed up to 60 minutes), and immediately after the procedure.
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Changes in systolic, diastolic, and mean arterial blood pressure, heart rate, and oxygen saturation during the procedure.
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Baseline, every 5 minutes during the procedure (assessed up to 60 minutes), and immediately after the procedure.
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Pain Intensity
時間枠：Baseline (pre-procedure), immediately after recovery, and at 30 minutes post-recovery.
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Pain intensity assessed using the Numeric Rating Scale (NRS)
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Baseline (pre-procedure), immediately after recovery, and at 30 minutes post-recovery.
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Sedation Depth
時間枠：Every 5 minutes during the procedure, assessed up to 30 minutes.
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Sedation level assessed using the Ramsay Sedation Scale.
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Every 5 minutes during the procedure, assessed up to 30 minutes.
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Adverse Events
時間枠：Perioperatively and through the recovery period, assessed up to 30 minutes.
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Incidence of sedation-related adverse events including hypotension, bradycardia, hypoxia, apnea, nausea, and vomiting.
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Perioperatively and through the recovery period, assessed up to 30 minutes.
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Patient and Operator Satisfaction
時間枠：Immediately after the procedure
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Patient and operator satisfaction assessed after completion of the procedure.
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Immediately after the procedure
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- TABED-1-25-1188
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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