Patient-controlled Sedation Versus Target-controlled Infusion in Orthopaedic Surgery Under Central Neuraxial Block
Propofol Sedation in Orthopaedic Surgery Under Central Neuraxial Block: Patient-controlled Sedation Versus Target-controlled Infusion
調査の概要
詳細な説明
Central neuraxial block (CNB) is one of the mainstays of anaesthesia methods in various disciplines particularly orthopaedic surgeries. However the state of consciousness can potentially cause patient anxiety thus sedation is often utilized as a mean to improve patient satisfaction and increase patient acceptance of CNB.
Conventionally, the anaesthesiologist administers sedatives for the patients. Propofol is the commonly used drug for sedation due to its favourable pharmacokinetic profile, which results in fast induction, easy control of depth of sedation and rapid recovery. It can be infused by using target-controlled infusion (TCI) devices where the anaesthetists titrates propofol by setting desired target plasma and effect site concentration. However it is difficult to judge precisely patient requirements for adequate patient sedation, comfort and analgesia as patients' needs differ.
Patient-controlled sedation (PCS) is a valid option, initially adapted from post surgery patient-controlled analgesia. It allows patients to titrate sedative medication to their comfort and therefore present an option that addresses the needs of patients with strong desire to maintain sense of control during procedures.
This study was designed to compare total propofol requirement between PCS versus TCI sedation (TCIS), complications and patient satisfaction, in patients undergoing lower limb orthopaedic surgery under CNB.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Kuala Lumpur
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Cheras、Kuala Lumpur、マレーシア、56000
- Pusat Perubatan Universiti Kebangsaan Malaysia
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) I or II.
- Aged 18-65 years.
- Elective lower limb orthopaedic surgery under CNB anticipated to last for 1.5 to 2 hours
Exclusion Criteria:
- Body Mass Index (BMI) > 30kg/m2
- Unable to cooperate (eg. mental disorders, language barrier)
- Drug abuse
- Alcoholism (chronic daily alcohol intake greater than 75 g of pure alcohol for ≥ 2 years, where 75g of alcohol = 5 cans of beer, 1 bottle of wine or half a pint of distilled spirit)
- Contraindications to the study drugs
- Pregnancy
- Significant pulmonary or cardiovascular diseases, including obstructive sleep apnoea and obesity hypoventilation syndrome
- Features of difficult airway
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：ヘルスサービス研究
- 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 |
|---|---|
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実験的：Group PCS
Patients in Group PCS (patient-controlled sedation) received intravenous (IV) propofol via a patient controlled analgesia (PCA) infusion pump.
The machine was set to deliver a demand bolus dose of 0.25 mg/kg with 1-minute lockout interval, without basal infusion.The patient was instructed to press on a hand-held device as often as required, to achieve their desired level of comfort or sedation.
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Patient-controlled propofol boluses for patients undergoing elective orthopaedic surgery under central neuraxial block
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アクティブコンパレータ：Group TCIS
Patients in Group TCIS (target-controlled infusion sedation) received IV propofol via a target-controlled infusion (TCI) pump, targeted at an initial effect site concentration (Cet) of 0.6 μg/ml, using the Schnider pharmacokinetic model.
Upon attainment of 0.6 μg/ml Cet, the patient's sedation level was assessed.
The Cet was increased or reduced accordingly by 0.2 μg/ml to attain an OAA/S score of 3.
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Patient-controlled propofol boluses for patients undergoing elective orthopaedic surgery under central neuraxial block
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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 |
|---|---|---|
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total propofol requirement between PCS versus TCI sedation (TCIS)
時間枠：Assessed from the beginning to the end of sedation, at the average of 120 minutes
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Total propofol requirement in both groups was calculated in mg/kg/hour.
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Assessed from the beginning to the end of sedation, at the average of 120 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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Patient satisfaction assessed by a 10-point numerical scale
時間枠：Within one hour after recovery from sedation
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Assessed using a 10-point verbal numerical rating scale (1 to 10), where 1 was regarded as extremely dissatisfied and 10 extremely satisfied.
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Within one hour after recovery from sedation
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Complications including incidence of hypotension, bradycardia, hypopnea, oxygen desaturation and over sedation
時間枠：Assessed from the beginning to the end of sedation, at the average of 120 minutes
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Documented as Yes or No for each specified complication
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Assessed from the beginning to the end of sedation, at the average of 120 minutes
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協力者と研究者
捜査官
- 主任研究者：Nadia Md Nor, MMED(Anaes)、Universiti Kebangsaan Malaysia Medical Centre
出版物と役立つリンク
一般刊行物
- Wahlen BM, Kilian M, Schuster F, Muellenbach R, Roewer N, Kranke P. Patient-controlled versus continuous anesthesiologist-controlled sedation using propofol during regional anesthesia in orthopedic procedures--a pilot study. Expert Opin Pharmacother. 2008 Nov;9(16):2733-9. doi: 10.1517/14656566.9.16.2733.
- Ekin A, Donmez F, Taspinar V, Dikmen B. Patient-controlled sedation in orthopedic surgery under regional anesthesia: a new approach in procedural sedation. Braz J Anesthesiol. 2013 Sep-Oct;63(5):410-4. doi: 10.1016/j.bjan.2012.07.012.
- Singh T, Ravishankar M. Conscious sedation with propofol for surgeries under spinal anaesthesia: anaesthesiologist versus patient controlled. J Anaesthesiol Clin Pharmacol. 21:169-173, 2005.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
その他の研究ID番号
- FF-2017-265
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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